protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04552470 | 8.2.3 | Vital Signs | 8.2.3. Vital Signs Supine BP will be measured with the participant's arm supported at the level of the heart, and recorded to the nearest mm Hg after approximately 5 minutes of rest. The same arm (preferably the dominant arm) will be used throughout the study. Participants should be instructed not to speak during measu... | [] |
NCT04552470 | 8.2.4 | Electrocardiograms | 8.2.4. Electrocardiograms Standard 12-lead ECGs should be collected at times specified in the [SOA](#page-12-0) section of this protocol using an ECG machine that automatically calculates the heart rate and measures PR, QT, and QTcF intervals and QRS complex. All scheduled ECGs should be performed after the participant... | [] |
NCT04552470 | 8.2.5 | Management of Glycemic Control | 8.2.5. Management of Glycemic Control HAEs and FPG will be routinely monitored during participation in the study. Based on this information, as well as review of the results reported by the central laboratory, an assessment of any symptomatic and asymptomatic occurrence of hypo- or hyper-glycemia must be undertaken. | [] |
NCT04552470 | 8.2.5.1 | Home Glucose Monitoring | 8.2.5.1. Home Glucose Monitoring - To aide in management of their T2DM, all participants will be provided home glucose monitoring supplies including a glucometer, instructions on the use of the glucometer and accompanying supplies. - Home glucose monitoring logs will be provided to participants for completion at home a... | [] |
NCT04552470 | 8.2.5.2 | Management of Hypoglycemia | 8.2.5.2. Management of Hypoglycemia GLP-1R agonists typically are not associated with hypoglycemia unless co-administered with anti-diabetic agents that can cause hypoglycemia (such as insulin or sulfonylureas), which are prohibited in this study. Blood glucose concentrations will be monitored throughout the study via ... | [] |
NCT04552470 | 8.2.5.2.1 | Definition and Severity of Categorization of Hypoglycemic Adverse Event (HAE) | 8.2.5.2.1. Definition and Severity of Categorization of Hypoglycemic Adverse Event (HAE) Based on review of the participant completed home glucose monitoring log at each time point specified in the [SOA](#page-12-0), as well as results reported by the central laboratory, the investigator must assess the glucose values ... | [
"3. Either:"
] |
NCT04552470 | 8.2.5.3 | Management of Hyperglycemia | 8.2.5.3. Management of Hyperglycemia Hyperglycemia is defined as the following: Fasting glucose ≥270 mg/dL (15.0 mmol/L) using glucometer (or central laboratory). After randomization, participants noted to have a fasting glucose value (during home glucose monitoring) meeting the above definition of hyperglycemia must b... | [] |
NCT04552470 | 8.2.6 | Clinical Safety Laboratory Assessments | 8.2.6. Clinical Safety Laboratory Assessments See [Appendix 2](#page-77-0) for the list of clinical safety laboratory tests to be performed and the [SOA](#page-12-0) for the timing and frequency. All protocol-required laboratory assessments, as defined in [Appendix 2](#page-77-0), must be conducted in accordance with t... | [] |
NCT04552470 | 8.2.7 | Pregnancy Testing | 8.2.7. Pregnancy Testing Pregnancy tests will be both urine and serum tests, and must have a sensitivity of at least 25 mIU/mL. Pregnancy tests will be performed in all females at the times listed in the [SOA.](#page-12-0) Following a negative pregnancy test result at screening, appropriate contraception must be commen... | [] |
NCT04552470 | 8.3 | Adverse Events and Serious Adverse Events | 8.3. Adverse Events and Serious Adverse Events The definitions of an AE and an SAE can be found in [Appendix](#page-80-0) 3. AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The investigator and any qualified designees are... | [] |
NCT04552470 | 8.3.1 | Time Period and Frequency for Collecting AE and SAE Information | 8.3.1. Time Period and Frequency for Collecting AE and SAE Information The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant begins from the time the participant provides informed consent, which is obtained before the participant's participation in the stud... | [] |
NCT04552470 | 8.3.1.1 | Reporting SAEs to Pfizer Safety | 8.3.1.1. Reporting SAEs to Pfizer Safety All SAEs occurring in a participant during the active collection period as described in Section 8.3.1 are reported to Pfizer Safety on the CT SAE Report Form immediately upon awareness and under no circumstance should this exceed 24 hours, as indicated in [Appendix](#page-80-0) ... | [] |
NCT04552470 | 8.3.1.2 | Recording Nonserious AEs and SAEs on the CRF | 8.3.1.2. Recording Nonserious AEs and SAEs on the CRF All nonserious AEs and SAEs occurring in a participant during the active collection period, which begins after obtaining informed consent as described in Section 8.3.1, will be recorded on the AE section of the CRF. The investigator is to record on the CRF all direc... | [] |
NCT04552470 | 8.3.2 | Method of Detecting AEs and SAEs | 8.3.2. Method of Detecting AEs and SAEs The method of recording, evaluating, and assessing causality of AEs and SAEs and the procedures for completing and transmitting SAE reports are provided in [Appendix](#page-80-0) 3. Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and nonleading... | [] |
NCT04552470 | 8.3.3 | Follow-up of AEs and SAEs | 8.3.3. Follow-up of AEs and SAEs After the initial AE/SAE report, the investigator is required to proactively follow each participant at subsequent visits/contacts. For each event, the investigator must pursue and obtain adequate information until resolution, stabilization, the event is otherwise explained, or the part... | [] |
NCT04552470 | 8.3.4 | Regulatory Reporting Requirements for SAEs | 8.3.4. Regulatory Reporting Requirements for SAEs Prompt notification by the investigator to the sponsor of an SAE is essential so that legal obligations and ethical responsibilities towards the safety of participants and the safety of a study intervention under clinical investigation are met. The sponsor has a legal r... | [] |
NCT04552470 | 8.3.5 | Exposure During Pregnancy or Breastfeeding, and Occupational Exposure | 8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational Exposure Exposure to the study intervention under study during pregnancy or breastfeeding and occupational exposure are reportable to Pfizer Safety within 24 hours of investigator awareness. | [] |
NCT04552470 | 8.3.5.1 | Exposure During Pregnancy | 8.3.5.1. Exposure During Pregnancy
An EDP occurs if: - A female participant is found to be pregnant while receiving or after discontinuing study intervention. - A male participant who is receiving or has discontinued study intervention exposes a female partner prior to or around the time of conception. - A female is f... | [
"An EDP occurs if:"
] |
NCT04552470 | 8.3.5.2 | Exposure During Breastfeeding | 8.3.5.2. Exposure During Breastfeeding An exposure during breastfeeding occurs if: - A female participant is found to be breastfeeding while receiving or after discontinuing study intervention. - A female is found to be breastfeeding while being exposed or having been exposed to study intervention (ie, environmental ex... | [] |
NCT04552470 | 8.3.5.3 | Occupational Exposure | 8.3.5.3. Occupational Exposure An occupational exposure occurs when a person receives unplanned direct contact with the study intervention, which may or may not lead to the occurrence of an AE. Such persons may include healthcare providers, family members, and other roles that are involved in the trial participant's ca... | [] |
NCT04552470 | 8.3.6 | Cardiovascular and Death Events | 8.3.6. Cardiovascular and Death Events Not applicable. | [] |
NCT04552470 | 8.3.7 | Disease Related Events and/or Disease Related Outcomes Not Qualifying as AEs or SAEs | 8.3.7. Disease Related Events and/or Disease Related Outcomes Not Qualifying as AEs or SAEs Not applicable. | [] |
NCT04552470 | 8.3.8 | Adverse Events of Special Interest | 8.3.8. Adverse Events of Special Interest Not applicable. | [] |
NCT04552470 | 8.3.8.1 | Lack of Efficacy | 8.3.8.1. Lack of Efficacy Lack of efficacy is reportable to Pfizer Safety only if associated with an SAE. | [] |
NCT04552470 | 8.3.9 | Medical Device Deficiencies | 8.3.9. Medical Device Deficiencies Not applicable. | [] |
NCT04552470 | 8.3.10 | Medication Errors | 8.3.10. Medication Errors Medication errors may result from the administration or consumption of the study intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength. Exposures to the study intervention under study may occur in clinical trial settings, such as medication errors. | Safe... | [
"Medication errors include:"
] |
NCT04552470 | 8.4 | Treatment of Overdose | 8.4. Treatment of Overdose For this study, any dose of study intervention greater than 12 tablets within a 24-hour time period 2 hours will be considered an overdose. Sponsor does not recommend specific treatment for an overdose. In the event of an overdose, the investigator should: - 1. Contact the medical monitor wit... | [] |
NCT04552470 | 8.5 | Pharmacokinetics | 8.5. Pharmacokinetics Blood samples of approximately 3 mL, to provide a minimum of 1 mL of plasma, will be collected into appropriately labeled tubes containing K2EDTA for measurement of plasma concentrations of PF-06882961 as specified in the [SOA.](#page-12-0) Instructions for the collection and handling of biologica... | [] |
NCT04552470 | 8.9 | Immunogenicity Assessments | 8.9. Immunogenicity Assessments Immunogenicity assessments are not included in this study. | [] |
NCT04552470 | 8.10 | Health Economics | 8.10. Health Economics Health economics/medical resource utilization and health economics parameters are not evaluated in this study. | [] |
NCT04552470 | 9 | STATISTICAL CONSIDERATIONS | 9. STATISTICAL CONSIDERATIONS Detailed methodology for summary and statistical analyses of the data collected in this study is outlined here and further detailed in a SAP, which will be maintained by the sponsor. The SAP may modify what is outlined in the protocol where appropriate; however, any major modifications of ... | [] |
NCT04552470 | 9.1 | Statistical Hypotheses | 9.1. Statistical Hypotheses No formal inferential statistics will be applied to the safety, tolerability, PK data. | [] |
NCT04552470 | 9.2 | Sample Size Determination | 9.2. Sample Size Determination A sample size of approximately 36 participants (approximately 9 participants in each of the placebo and 3 PF-06882961 arms) has been selected empirically to permit adequate characterization of safety, tolerability, PK at each dose level in Japanese participants with T2DM. Participants who... | [] |
NCT04552470 | 9.3 | Analysis Sets | 9.3. Analysis Sets For purposes of analysis, the following analysis sets are defined: PFIZER CONFIDENTIAL | ParticipantAnalysis Set | Description | | |-----------------------------|---------------------------------------------------------------------|--| | Enrolled/Randomly | "Enrolled" means a participant's agreement ... | [] |
NCT04552470 | 9.4 | Statistical Analyses | 9.4. Statistical Analyses The SAP will be developed and finalized before any analyses are performed and will describe the analyses and procedures for accounting for missing, unused, and spurious data. This section is a summary of the planned statistical analyses of the primary and secondary endpoints. | [] |
NCT04552470 | 9.4.1 | General Considerations | 9.4.1. General Considerations All treatment arms of PF-06882961 and placebo will be reported separately. | [] |
NCT04552470 | 9.4.2 | Primary Endpoint(s) | 9.4.2. Primary Endpoint(s) All safety and tolerability analyses will be performed on the safety population. AEs, ECGs, BP, PR, and safety laboratory data will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of participants. Any clinical laboratory, ECG, BP, and PR abnormalities of... | [] |
NCT04552470 | 9.4.2.1 | Electrocardiogram Interval Analyses | 9.4.2.1. Electrocardiogram Interval Analyses Changes from baseline for the ECG parameters QT interval, heart rate, QTcF interval, PR interval, and QRS complex will be summarized by treatment and time. The number (%) of participants with maximum postdose QTcF values and maximum increases from baseline in the following c... | [
"Safety QTc Assessment"
] |
NCT04552470 | 9.4.3 | Secondary Endpoint(s) | 9.4.3. Secondary Endpoint(s) | [] |
NCT04552470 | 9.4.3.1 | Pharmacokinetic Analyses of PF-06882961 | 9.4.3.1. Pharmacokinetic Analyses of PF-06882961 The PK parameters (AUC24, Cmax, Tmax, t½) for PF-06882961 following Day 1 and multiple dose administration will be derived from the concentration-time profiles, as data permit. The PK parameters to be assessed in this study, their definition and method of determination a... | [] |
NCT04552470 | 9.4.5 | Other Safety Analyses | 9.4.5. Other Safety Analyses | [] |
NCT04552470 | 9.4.5.1 | Hypoglycemia Monitoring and Reporting | 9.4.5.1. Hypoglycemia Monitoring and Reporting The HAEs will be listed in a separate table and summarized categorically.  | [] |
NCT04552470 | 9.5 | Interim Analyses | 9.5. Interim Analyses No formal interim analysis will be conducted for this study. As this is an sponsor-open study, the sponsor may conduct unblinded reviews of the data during the course of the study for the purpose of safety assessment, and/or supporting clinical development. | [] |
NCT04552470 | 9.6 | Data Monitoring Committee or Other Independent Oversight Committee | 9.6. Data Monitoring Committee or Other Independent Oversight Committee This study will not use a DMC. | [] |
NCT04552470 | 10 | SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS | 10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS | [] |
NCT04552470 | 10.1 | Appendix 1: Regulatory, Ethical, and Study Oversight Considerations | 10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations | [] |
NCT04552470 | 10.1.1 | Regulatory and Ethical Considerations | 10.1.1. Regulatory and Ethical Considerations This study will be conducted in accordance with the protocol and with the following: - Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and CIOMS International Ethical Guidelines; - Applicable ICH GCP guidelines; - App... | [] |
NCT04552470 | 10.1.1.1 | Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP | 10.1.1.1. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable regulatory authority in any area of the world, or if the investigator is aware of any new information that might influence the evaluation of th... | [] |
NCT04552470 | 10.1.2 | Financial Disclosure | 10.1.2. Financial Disclosure Investigators and subinvestigators will provide the sponsor with sufficient, accurate financial information as requested to allow the sponsor to submit complete and accurate financial certification or disclosure statements to the appropriate regulatory authorities. Investigators are respons... | [] |
NCT04552470 | 10.1.3 | Informed Consent Process | 10.1.3. Informed Consent Process The investigator or his/her representative will explain the nature of the study to the participant and answer all questions regarding the study. The participant should be given sufficient time and opportunity to ask questions and to decide whether or not to participate in the trial. Par... | [] |
NCT04552470 | 10.1.4 | Data Protection | 10.1.4. Data Protection All parties will comply with all applicable laws, including laws regarding the implementation of organizational and technical measures to ensure protection of participant data. Participants' personal data will be stored at the study site in encrypted electronic and/or paper form and will be pass... | [] |
NCT04552470 | 10.1.5 | Dissemination of Clinical Study Data | 10.1.5. Dissemination of Clinical Study Data Pfizer fulfills its commitment to publicly disclose clinical study results through posting the results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the EudraCT, and/or www.pfizer.com, and other public registries in accordance with applicable local laws/regulati... | [
"www.clinicaltrials.gov",
"EudraCT",
"www.pfizer.com",
"Documents within marketing authorization packages/submissions",
"Data Sharing"
] |
NCT04552470 | 10.1.6 | Data Quality Assurance | 10.1.6. Data Quality Assurance All participant data relating to the study will be recorded on printed or electronic CRF unless transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator is responsible for verifying that data entries are accurate and correct by physically or electronic... | [] |
NCT04552470 | 10.1.7 | Source Documents | 10.1.7. Source Documents Source documents provide evidence for the existence of the participant and substantiate the integrity of the data collected. Source documents are filed at the investigator site. Data reported on the CRF or entered in the eCRF that are from source documents must be consistent with the source doc... | [] |
NCT04552470 | 10.1.8 | Study and Site Start and Closure | 10.1.8. Study and Site Start and Closure The study start date is the date on which the clinical study will be open for recruitment of participants. The first act of recruitment is the date of the first participant's first visit and will be the study start date. The sponsor designee reserves the right to close the study... | [] |
NCT04552470 | 10.1.9 | Publication Policy | 10.1.9. Publication Policy The results of this study may be published or presented at scientific meetings by the investigator after publication of the overall study results or 1 year after the end of the study (or study termination), whichever comes first. The investigator agrees to refer to the primary publication in ... | [] |
NCT04552470 | 10.1.10 | Sponsor's Qualified Medical Personnel | 10.1.10. Sponsor's Qualified Medical Personnel The contact information for the sponsor's appropriately qualified medical personnel for the study is documented in the study contact list located in the study team on demand system. To facilitate access to appropriately qualified medical personnel on study-related medical ... | [] |
NCT04552470 | 10.2 | Appendix 2: Clinical Laboratory Tests | 10.2. Appendix 2: Clinical Laboratory Tests The following laboratory tests will be performed at times defined in the [SOA](#page-12-0) section of this protocol. Additional laboratory results may be reported on these samples as a result of the method of analysis or the type of analyzer used by the clinical laboratory, o... | [] |
NCT04552470 | 10.3 | Appendix 3: Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-up, and Reporting | 10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-up, and Reporting | [] |
NCT04552470 | 10.3.1 | Definition of AE | 10.3.1. Definition of AE
AE Definition - An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. - NOTE: An AE can therefore be any unfavorable and unintended sign (includ... | [
"AE Definition",
"Events Meeting the AE Definition",
"Events NOT Meeting the AE Definition"
] |
NCT04552470 | 10.3.2 | Definition of SAE | 10.3.2. Definition of SAE If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions are met (eg, hospitalization for signs/symptoms of the disease under study, death due to progression of disease).
An SAE is defined as any untoward medical occurrence that, at any dose:
a. Resu... | [
"An SAE is defined as any untoward medical occurrence that, at any dose:",
"a. Results in death",
"b. Is life-threatening",
"c. Requires inpatient hospitalization or prolongation of existing hospitalization",
"d. Results in persistent disability/incapacity",
"e. Is a congenital anomaly/birth defect",
"f... |
NCT04552470 | 10.3.3 | Recording/Reporting and Follow-up of AEs and/or SAEs | 10.3.3. Recording/Reporting and Follow-up of AEs and/or SAEs
AE and SAE Recording/Reporting The table below summarizes the requirements for recording adverse events on the CRF and for reporting serious adverse events on the CT SAE Report Form to Pfizer Safety. These requirements are delineated for 3 types of events: (... | [
"AE and SAE Recording/Reporting",
"Assessment of Intensity",
"Assessment of Causality",
"for every event before the initial transmission of the SAE data to the sponsor.",
"Follow-up of AEs and SAEs"
] |
NCT04552470 | 10.3.4 | Reporting of SAEs | 10.3.4. Reporting of SAEs
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool The primary mechanism for reporting an SAE to Pfizer Safety will be the electronic data collection tool. - If the electronic system is unavailable, then the site will use the paper SAE data collection tool (see next section... | [
"SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool",
"SAE Reporting to Pfizer Safety via CT SAE Report Form"
] |
NCT04552470 | 10.4 | Appendix 4: Contraceptive Guidance | 10.4. Appendix 4: Contraceptive Guidance | [] |
NCT04552470 | 10.4.1 | Male Participant Reproductive Inclusion Criteria | 10.4.1. Male Participant Reproductive Inclusion Criteria No contraception methods are required for male participants in this study, as the calculated safety margin is ≥100-fold between the estimated maternal exposure due to seminal transfer and the NOAEL for serious manifestations of developmental toxicity in nonclinic... | [] |
NCT04552470 | 10.4.2 | Female Participant Reproductive Inclusion Criteria | 10.4.2. Female Participant Reproductive Inclusion Criteria A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: Is not a WOCBP (see definitions below in Section 10.4.3). OR - Is a WOCBP and using a contraceptive method that is highl... | [] |
NCT04552470 | 10.4.3 | Woman of Childbearing Potential | 10.4.3. Woman of Childbearing Potential A woman is considered fertile following menarche and until becoming postmenopausal unless permanently sterile (see below). If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot be confirmed before the first dose of study intervention, ad... | [] |
NCT04552470 | 10.4.4 | Contraception Methods | 10.4.4. Contraception Methods Contraceptive use by men or women should be consistent with local availability/regulations regarding the use of contraceptive methods for those participating in clinical trials.
Highly Effective Methods That Have Low User Dependency - 1. Implantable progestogen-only hormone contraception ... | [
"Highly Effective Methods That Have Low User Dependency",
"Highly Effective Methods That Are User Dependent",
"PFIZER CONFIDENTIAL"
] |
NCT04552470 | 10.6 | Appendix 6: Liver Safety: Suggested Actions and Follow-up Assessments Potential Cases of Drug-Induced Liver Injury | 10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-up Assessments Potential Cases of Drug-Induced Liver Injury Humans exposed to a drug who show no sign of liver injury (as determined by elevations in transaminases) are termed "tolerators," while those who show transient liver injury, but adapt are termed "ad... | [] |
NCT04552470 | 10.7 | Appendix 7: ECG Findings of Potential Clinical Concern | 10.7. Appendix 7: ECG Findings of Potential Clinical Concern
ECG Findings That May Qualify as AEs - Marked sinus bradycardia (rate 280 msec. - New prolongation of QTcF to >480 msec (absolute) or by 60 msec from baseline. - New-onset atrial flutter or fibrillation, with controlled ventricular response rate: ie, rate 30... | [
"ECG Findings That May Qualify as AEs",
"ECG Findings That May Qualify as SAEs",
"ECG Findings That Qualify as SAEs"
] |
NCT04552470 | 10.8 | Appendix 8: Prohibited Prior/Concomitant Medications | 10.8. Appendix 8: Prohibited Prior/Concomitant Medications The following medications are prohibited until the first follow-up visit (ie, Visit 11, Week 9-10), unless stated otherwise. If a participant receives a prohibited medication, the investigator should contact the Sponsor Clinician or Sponsor Medical Monitor to d... | [] |
NCT04552470 | 10.9 | Appendix 9: Proposed Chronology of Procedures | 10.9. Appendix 9: Proposed Chronology of Procedures For the procedures described below, where multiple procedures are scheduled at the same timepoint(s) relative to dosing, the following chronology of events should be adhered to: - 12-lead ECG: obtain prior to blood samples, and prior to dosing (except for post-dose co... | [] |
NCT04552470 | C | CCI | C CCI C - Post-dose PK blood collection to occur approximately 4 hours post-dose (see [Section 8.5](#page-59-0)): if collection time coincides with time of a meal/snack, these blood samples should be collected just prior to the meal/snack; - Other pre-dose procedures: obtain sample/perform procedure as close as possibl... | [
"10.10. Appendix 10: Abbreviations",
"11. REFERENCES"
] |
NCT04587193 | 4 | \ List the study inclusion criteria: | 4. \ List the study inclusion criteria: Parkinson's Participant - 1) age 21 years or older, - 2) PD confirmed by a movement disorder specialist using UK Brain Bank Criteria, - 3) H&Y stage II, III, IV, or V. Caregiver participant 1) Willing to complete questionnaire | [] |
NCT04587193 | 5 | \ List the study exclusion criteria: | 5. \ List the study exclusion criteria: Parkinson's Participant - 1) neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of gait, stance, balance or coordination, - 2) history of implantable cardiac device or ablative surgery, - 3) moderate to severe cognitive impairment / demen... | [
"Background, Rationale & Goals Section Complete",
"Study Procedures",
"NOTE - A POST-CARD/FLIER WILL BE UPLOADED AFTER IRB APPROVAL WITH AN AMENDMENT.",
"TIMING AND FREQUENCY OF RECRUITMENT ACTIVITIES",
"WHERE AND HOW RECRUITMENT PROCEDURES WILL BE COMPLETED",
"WHO WILL RECRUIT OR RESPOND TO POTENTIAL PAR... |
NCT04587193 | 9 | \ Describe the other ways the study team will minimize any potential perception of undue influence to participate: | 9. \ Describe the other ways the study team will minimize any potential perception of undue influence to participate: Participants will be told verbally and in writing on the ICF that participation is voluntary and that they may decline without prejudice to their ongoing care. | [] |
NCT04587193 | 10 | \ How much time will participants be given to make a decision: | 10. \ How much time will participants be given to make a decision: They will be allowed to take as much time as needed to read the ICF, ask questions, and make a decision. If they wish to take the informed consent form (ICF) home to think about it, they may do that and return at a later date to enroll in the study. 11.... | [
"Consent Groups",
"Consent Groups",
"Name Signed Consent by Participant Signed Parent/Guardian Permission or Legally Authorized Representative Consent Signed Assent by Child or Decisionally Impaired Adult Verbal Assent by Child or Decisionally Impaired Adult Short Form Consent (limited applicability) None of th... |
NCT04607837 | C | LI NI C A L S T U D Y P R O T O C O L | C LI NI C A L S T U D Y P R O T O C O L Pr ot oc ol n u m ber: A P D 3 3 4 2 1 0 Pr ot oc ol title: A Ra n d o mize d, D o u ble Bli n d, Place b o C o ntr olle d, 5 2 Wee k St u d y t o Assess t he Efficac y a n d Safet y of Etrasi m o d i n S u bjects wit h M o deratel y Acti ve Ulcerati ve C olitis Brief title: G L ... | [] |
NCT04607837 | C | o nfi de nti alit y St ate me nt | C o nfi de nti alit y St ate me nt T his d oc u me nt c o ntai ns c o nfi de ntial i nf or mati o n of Are na P har mace uticals, I nc. U na ut h orize d distri b uti o n, c o p yi n g, or discl os ure is strictl y pr o hi bite d u nless re q uire d b y a p plica ble la w. Pers o ns recei vi n g t his i nf or mati o n ... | [] |
NCT04607837 | P | R O T O C O L HI S T O R Y | P R O T O C O L HI S T O R Y | D oc u me nt | A me n d me nt T y pe | D ate | | |------------------------|---------------------------|--------------------------------|--| | me n d me nt 2. 0 | Gl o bal | 0 4 A u g ust 2 0 2 2 | | | A me n d me nt 1. 1 | Re gi o nS pecific | 1 7J u ne 2 0 2 1 | | | A me n d me nt 1. 0 |... | [] |
NCT04607837 | P | R O T O C O L S Y N O P SI S | P R O T O C O L S Y N O P SI S S p o ns or: Are na P har mace uticals, I nc. N a me of i n vesti g ati o n al st u d y dr u g: Etrasi m o d ( A P D 3 3 4) Pr ot oc ol n u m ber: A P D 3 3 4 2 1 0 Pr ot oc ol title: A Ra n d o mize d, D o u ble Bli n d, Place b o C o ntr olle d, 5 2 Wee k St u d y t o Assess t he Effica... | [
"O bjecti ves:",
"Pri mar y",
"Sec o n dar y",
"Safet y",
"Ot her",
"St u d y desi g n:",
"E n d of 1 2 Wee k D o u ble Bli n d Tre at me nt Peri o d",
"E n d of 4 0 Wee k D o u ble Bli n d Tre at me nt Peri o d ( Wee k 5 2)",
"O pe n L a bel E xte nsi o n St u d y ( St u d y A P D 3 3 4 3 0 3)",
... |
NCT04607837 | P | h ar m ac o ki netic assess me nts: | P h ar m ac o ki netic assess me nts: Plas ma c o nce ntrati o ns of etrasi m o d will be assesse d fr o m sa m ples c ollecte d pre d ose a n d h o urs p ost d ose (after 1 2 lea d E C G) o n Wee k 0/ Da y 1, a n d pre d ose (tr o u g h at Wee ks 2, 4, 8, 1 2, 1 6, 2 4, 3 2, 4 8, 5 2 a n d Earl y Ter mi nati o n ( E T... | [
"Ot her assess me nts:",
"Bi o mar ker e n d p oi nts",
"Healt h relate d q ualit y of life e n d p oi nts"
] |
NCT04607837 | S | afet y assess me nts: | S afet y assess me nts: Safet y will be assesse d usi n g m o nit ori n g of a d verse e ve nts, cli nical la b orat or y fi n di n gs, 1 2 lea d E C Gs , H olter rec or di n g, p h ysical e xa mi nati o ns, vital si g ns, p ul m o nar y f u ncti o n tests, o p ht hal m osc o p y, a n d o ptical c o here nce t o m o gr... | [
"Saf et y e n d p oi nts",
"St atistic al met h o ds:",
"Deter mi nati o n of sa m ple size",
"Efficac y a nal ysis",
"M ulti ple c o m paris o n pr oce d ure",
"P har mac o ki netic a nal ysis",
"Safet y a nal ysis",
"I nteri m a nal ysis",
"LI S T O F A P P E N DI C E S",
"LI S T O F A B B R E V... |
NCT04607837 | T | a ble Disc h ar ge Criteri a After C ar di ac M o nit ori n g | T a ble Disc h ar ge Criteri a After C ar di ac M o nit ori n g S u bjects will be rele ase d fr o m t he cli nic al site after d osi n g o n D a y 1 ( b ut n o s o o ner t h a n 4 h o urs p ost d ose) w he n t he y f ulfill t he f oll o wi n g disc h ar ge criteri a: - Heart rate ≥ 5 0 b p m or n o m ore t ha n 1 0 b ... | [
"E xte n de d C ar di ac M o nit ori n g",
"St u d y Tre at me nt Disc o nti n u ati o n Rel ate d t o P ost ose ar di ac M o nit ori n g",
"Re as o ns f or St u d y Tre at me nt Disc o nti n u ati o n Rel ate d t o P ost d ose C ar di ac M o nit ori n g",
"C ar di ac M o nit ori n g U p o n Tre at me nt Re I... |
NCT04607837 | T | a ble Cli nic al L a b or at or y Tests | T a ble Cli nic al L a b or at or y Tests C R E E NI N G O N L Y Vir ol o g y HI V, H Bs A g, H C V ( RI B A) St o ol S a m ple Bacterial c ult ure, o va a n d parasites, C. difficile Dr u gs of A b use A m p heta mi ne, bar bit urates, be nz o diaze pi nes, c ocai ne, met ha d o ne, met ha m p heta mi ne, met h yle ne... | [
"P R E G N A N C Y T E S TI N G",
"C LI NI C A L C H E MI S T R Y, H E M A T O L O G Y, A N D C O A G U L A TI O N"
] |
NCT04607837 | U | RI N A L Y SI S | U RI N A L Y SI S A p peara nce Bilir u bi n Nitrite Occ ult bl o o d C ol or Gl uc ose p H Pr otei n Ket o nes Micr osc o pic e xa mi nati o n of S pecific gra vit y Ur o bili n o ge n se di me nt
T a ble Cli nic al L a b or at or y Tests ( C o nti n ue d) | BI OM A R K E R S | |------------------------------------| ... | [
"T a ble Cli nic al L a b or at or y Tests ( C o nti n ue d)",
"9. 9. 8. 1. Scree ni n g",
"9. 9. 8. 1. 1. Dr u gs of A b use",
"9. 9. 8. 1. 2. Pre g n a nc y Testi n g",
"9. 9. 8. 1. 3. Vir ol o g y",
"9. 9. 8. 2. Cli nic al C he mistr y, He m at ol o g y, C o a g ul ati o n, a n d Uri n al ysis",
"9. ... |
NCT04622332 | A | Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess Safety and Efficacy of SIR1-365 in Patients with Severe COVID-19 Study Number: SIR365-US-101 | A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess Safety and Efficacy of SIR1-365 in Patients with Severe COVID-19 Study Number: SIR365-US-101 | | SIR365-US-101 Clinical Study Report | |-----------------------------------|----------------------------------------------------------------------... | [
"Confidentiality Statement",
"Study Title:",
"Sponsor:",
"Study Number:",
"Study Phase:",
"Investigational Product, Dosage and Mode of Administration:",
"Reference Therapies, Dosage and Mode of Administration:",
"Objectives:",
"Primary Objective:",
"Secondary Objectives:",
"Introduction:",
"St... |
NCT04691115 | 1 | INTRODUCTION | 1. INTRODUCTION | [] |
NCT04691115 | 1.1 | Overview | 1.1. Overview AM1476 is a 5-hydroxytryptamine receptor 2B (5-HT2B) antagonist being developed by AnaMar AB for the treatment of systemic sclerosis. Peripheral 5-HT2B receptors have been suggested to play a significant role in fibrosis, with the receptor being upregulated in fibrotic tissues. Activation of the 5-HT2B re... | [] |
NCT04691115 | 1.2 | Summary of Non-clinical Pharmacology | 1.2. Summary of Non-clinical Pharmacology AM1476 has been evaluated for 5-HT2B receptor interactions using mouse, rat, and human receptors. Both binding (human only) assays and functionality assays have been employed. In a chronic graft versus host disease (cGvHD) model of systemic sclerosis (SSc) using minor histocomp... | [
"(GLP Study)",
"I"
] |
NCT04691115 | 1.6.2 | 13-Week Oral Toxicity Study in Mice (GLP Study) | 1.6.2. 13-Week Oral Toxicity Study in Mice (GLP Study) This administered study in orally mice was to Crl:CD1(ICR) conducted in accordance mice (12/sex/toxicity with GLP, groups; in which 3 AM1476 [control] or was 18/sex/toxicokinetic groups) for 13 weeks to determine toxicity and toxicokinetic profile. Mice were admini... | [] |
NCT04691115 | 1.6.3 | 28-day Study) Oral Toxicity Study with a 4-week Recovery Period in Dogs (GLP | 1.6.3. 28-day Study) Oral Toxicity Study with a 4-week Recovery Period in Dogs (GLP AM1476 This 30 mg/kg/day, pivotal was toxicology administered or 65 mg/kg/day study orally in to dogs at beagle 0 was mg/kg/day dogs conducted (5/sex (vehicle in in accordance the control), control with 15 and mg/kg/day, high-dose GLP, ... | [] |
NCT04691115 | 1.10 | Benefit-risk Assessment | 1.10. Benefit-risk Assessment Healthy subjects in the current study will not receive any health benefit (beyond that of an assessment of their medical status) from participating in the study. The risks of participation are primarily those associated with adverse reactions to the investigational medicinal product (IMP),... | [] |
NCT04691115 | 2 | OBJECTIVES AND ENDPOINTS | 2. OBJECTIVES AND ENDPOINTS | [] |
NCT04691115 | 2.1 | Objectives | 2.1. Objectives The primary objective of the study is: • to determine the safety and tolerability of single and multiple oral doses of AM1476 in healthy subjects. The secondary objectives of the study are: - to determine the single- and multiple-oral dose PK of AM1476 in healthy subjects. - to determine the effect of f... | [] |
NCT04691115 | 2.2 | Endpoints | 2.2. Endpoints | [] |
NCT04691115 | 2.2.1 | Primary Endpoints | 2.2.1. Primary Endpoints The primary safety endpoints for this study are as follows: - incidence and severity of AEs - incidence of laboratory abnormalities, based on haematology, clinical chemistry, coagulation, and urinalysis test results - vital signs measurements - 12-lead ECG parameters - telemetry - neurological ... | [] |
NCT04691115 | 2.2.2 | Secondary Endpoints | 2.2.2. Secondary Endpoints For Part A, the single-ascending dose and food (fed versus fasted dietary status at dosing), PK outcome endpoints of AM1476 are as follows: - area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) - area under the plasma concentration-time curve from time zero to t... | [] |
NCT04691115 | 3 | INVESTIGATIONAL PLAN | 3. INVESTIGATIONAL PLAN | [] |
NCT04691115 | 3.1 | Overall Study Design and Plan | 3.1. Overall Study Design and Plan This will be a double-blind, randomised, placebo-controlled, single- and multiple-oral dose study conducted in 2 parts. | [] |
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