protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT05377866 | 3.3 | Study process | 3.3 Study process Study will be conducted by two participants where one is defined as expert or proctor and the other as operator who will perform the CTO procedure. Operator carries out the procedure in our institution while expert is located 300 km away. The plan is to conduct ten CTO procedures where the operator us... | [] |
NCT05377866 | 3.4 | Statistics | 3.4 Statistics 3.4.1 Statistical analyses will be performed in IBM SPSS for Windows (IBM Corp., Armonk, NY, USA). Values will be presented as mean ± standard deviation, median (interquartile range) or no (%) as appropriate. | [] |
NCT05377866 | 3.5 | Data management | 3.5 Data management Each participant will be given a unique study subject number. A list of participating patients and their respective study numbers will be kept in a secure place in a locked office. Patient data will be stored in a de-identified manner in a secure database. | [] |
NCT05377866 | 4 | Ethical aspects | 4. Ethical aspects 4.1 This study is conducted in accordance with the protocol, applicable regulatory requirements and the declaration of Helsinki. The primary investigator has the responsibility to obtain approval of the study protocol, the patient information and the informed consent. | [] |
NCT05377866 | 4.2 | Risks, side effects, advantages and disadvatanges in participating in the study | 4.2 Risks, side effects, advantages and disadvatanges in participating in the study Complex CTO PCI is in itself associated with decreased success rate and higher complication risk compared to ordinary PCI in non-occluded vessels. This study group finds no reason to believe there should be safety concerns connected to ... | [] |
NCT05377866 | 5 | Patient information and informed consent | 5. Patient information and informed consent Patients will get written information about the study. Informed consent for participation in the study will be obtained from all patients. The patients will be informed that taking part is entirely voluntarily and that they can withdraw for study whenever they want. Withdrawa... | [] |
NCT05377866 | 6 | Biological material | 6. Biological material Biological material will not be drawn or stored in the study | [] |
NCT05377866 | 7 | Enrolment period | 7. Enrolment period Enrolment is expected to conclude in first quarter of 2022 | [] |
NCT05377866 | 8 | Publication | 8. Publication Results will be published in a peer reviewed international cardiovascular journal. | [] |
NCT05377866 | 9 | Study group | 9. Study group A study group is responsible for this protocol, administrates the study implementation and progression. - 1. Fefer, P., et al. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol 2012; 59: 991-7. - 2. Brilakis, Emmanouil... | [] |
NCT05412004 | 1 | Protocol Summary | 1. Protocol Summary | [] |
NCT05412004 | 1.1 | Synopsis | 1.1. Synopsis Master Protocol Title: A Master Protocol to Investigate the Efficacy and Safety of Tirzepatide Once Weekly in Participants who have Obstructive Sleep Apnea and Obesity: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-OSA) Brief Title: A Master Protocol for Tirzepatide in Participants with O... | [
"Rationale:",
"Objectives, Endpoints, and Estimands:",
"Overall Design:",
"Number of Participants:",
"Intervention Groups and Duration:"
] |
NCT05412004 | 1.2 | Schema Master Protocol and ISA Schema | 1.2. Schema Master Protocol and ISA Schema  Abbreviations: ISA = intervention-specific appendix; MTD = maximum-tolerated dose; PAP = positive airway pressure.
Dose Escalation and Visit Schema  Abbreviations: MTD = maximum-tolerated dose; QW = once weekly. | [
"Dose Escalation and Visit Schema"
] |
NCT05412004 | 1.3 | Schedule of Activities (SoA) | 1.3. Schedule of Activities (SoA) If Study Period I - Screening takes longer or shorter than 4 weeks to complete, it will not be considered a protocol deviation. Study Period I - Screening should not exceed 6 weeks unless approval from the sponsor is received. Visit procedures may be conducted over more than 1 day as l... | [] |
NCT05412004 | 2 | Introduction | 2. Introduction | [] |
NCT05412004 | 2.1 | Study Rationale | 2.1. Study Rationale Obstructive sleep apnea is a breathing disorder associated with significant comorbidity and mortality. Currently available therapeutic approaches have shown moderate success in treating the clinical signs and symptoms of OSA (that is, snoring and excessive daytime sleepiness) but have failed to add... | [] |
NCT05412004 | 2.2 | Background | 2.2. Background Obstructive sleep apnea is a serious medical condition with a limited number of therapeutic options and high unmet need. OSA is a well-established risk factor for morbidity and mortality from CV and other metabolic diseases; further, it negatively affects daily life of patients (Tietjens et al. 2019; Go... | [] |
NCT05412004 | 2.3 | Benefit/Risk Assessment | 2.3. Benefit/Risk Assessment More detailed information about the known and expected benefits and risks and reasonably expected AEs of tirzepatide may be found in the IB. | [] |
NCT05412004 | 3 | Objectives, Endpoints, and Estimands | 3. Objectives, Endpoints, and Estimands The following objectives and endpoints apply to both ISAs. | Primary Objective | Endpoints | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT05412004 | 4 | Study Design | 4. Study Design | [] |
NCT05412004 | 4.1 | Overall Design | 4.1. Overall Design Study I8F-MC-GPIF (GPIF) is a multicenter, randomized, parallel-arm, double-blind, placebocontrolled Phase 3 study to evaluate the efficacy and safety of tirzepatide at the MTD (10 mg or 15 mg) QW versus placebo in participants who have obesity and moderate-to-severe OSA. This basket-type master pro... | [] |
NCT05412004 | 4.2 | Scientific Rationale for Study Design | 4.2. Scientific Rationale for Study Design The basket trial design employs a single overarching trial structure as a means to implement multiple investigations (Woodcock and LaVange 2017). Such approaches often allow for more streamlined and coordinated clinical trial logistics and consistency in data collection method... | [] |
NCT05412004 | 4.3 | Justification for Dose | 4.3. Justification for Dose Tirzepatide doses of up to 15 mg administered SC QW will be evaluated in this study. Participants may be treated with lower maintenance dose of 10 mg if they do not achieve full dose escalation to 15 mg and/or do not tolerate 15 mg. These doses and associated escalation schemes were selected... | [] |
NCT05412004 | 4.4 | End of Study Definition | 4.4. End of Study Definition A participant is considered to have completed the study if they have completed all required phases of the study including the last visit or the last scheduled procedure shown in the SoA. The end of the study for each ISA is defined as the date of the last visit of the last participant in th... | [] |
NCT05412004 | 5 | Study Population | 5. Study Population Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as protocol waivers or exemptions, is not permitted. | [] |
NCT05412004 | 5.1 | Inclusion Criteria | 5.1. Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply:
Age 1. Participant must be at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age, inclusive, at the time of signing the informed consent.
T... | [
"Age",
"Type of Participant and Disease Characteristics",
"Weight",
"Sex and Contraceptive/Barrier Requirements",
"Informed Consent"
] |
NCT05412004 | 5.2 | Exclusion Criteria | 5.2. Exclusion Criteria Participants are excluded from the study if any of the following criteria apply:
Medical Conditions Diabetes-related - 9. Have T1DM or T2DM, history of ketoacidosis, or hyperosmolar state/coma. - 10. HbA1c ≥ 6.5% (≥ 48 mmol/mol) at Visit 1.
OSA-related - 11. Any previous or planned surgery for... | [
"Medical Conditions",
"OSA-related",
"Obesity-related",
"Other medical",
"Prior/Concomitant Therapy",
"Prior/Concurrent Clinical Study Experience"
] |
NCT05412004 | 5.3 | Lifestyle Considerations | 5.3. Lifestyle Considerations Per the SoA (Section [1.3\)](#page-14-0), participants will consult with study personnel experienced in diet and exercise counseling to receive lifestyle program instructions at timepoints indicated in the SoA. Diet and exercise goals and the importance of adherence to the lifestyle progra... | [] |
NCT05412004 | 5.3.1 | Meals and Dietary Restrictions | 5.3.1. Meals and Dietary Restrictions At Visit 2 and subsequent visits, participants will consult with study personnel experienced in diet and exercise counseling to receive lifestyle program instructions at timepoints indicated in the SoA. Dietary counseling will consist of advice on healthy food choices and focus on ... | [
"Equations for estimating BMR in kcal/daya"
] |
NCT05412004 | 5.3.2 | Physical Activity | 5.3.2. Physical Activity At Visit 2 and all subsequent visits, participants will be advised to increase their physical activity to at least 150 minutes per week. aRevised WHO equations (Adapted from: FAO/WHO/UNU 2004). | [] |
NCT05412004 | 5.4 | Screen Failures | 5.4. Screen Failures A screen failure occurs when a participant who consents to participate in the clinical study is not subsequently randomly assigned to study intervention in the study. A minimal set of screen failure information is required to ensure transparent reporting of screen failure participants to meet the C... | [] |
NCT05412004 | 5.5 | Criteria for Temporarily Delaying Enrollment/Randomization/Administration of Study Intervention of a Participant | 5.5. Criteria for Temporarily Delaying Enrollment/Randomization/Administration of Study Intervention of a Participant Not applicable. | [] |
NCT05412004 | 6 | Study Intervention(s) and Concomitant Therapy | 6. Study Intervention(s) and Concomitant Therapy Study intervention is defined as any investigational intervention(s), marketed product(s), placebo, or medical device(s) intended to be administered to/used by a study participant according to the study protocol. 6.1. Study Interventions Administered | Intervention | Tir... | [] |
NCT05412004 | 6.1.1 | Medical Devices | 6.1.1. Medical Devices The combination products provided for use in the study are tirzepatide autoinjector (or matching placebo). Any medical-device incidents, including those resulting from malfunctions of the device, must be detected, documented, and reported by the investigator throughout the study (see Section [10.... | [] |
NCT05412004 | 6.2 | Preparation, Handling, Storage, and Accountability | 6.2. Preparation, Handling, Storage, and Accountability - The investigator or designee must confirm appropriate storage conditions have been maintained during transit for all study intervention received and any discrepancies are reported and resolved before use of the study intervention. - Only participants enrolled in... | [] |
NCT05412004 | 6.3 | Measures to Minimize Bias: Randomization and Blinding | 6.3. Measures to Minimize Bias: Randomization and Blinding All participants will be centrally randomly assigned to study intervention using an IWRS. Before the study is initiated, the log in information and directions for the IWRS will be provided to each site. Study intervention will be dispensed at the study visits s... | [
"Stratification"
] |
NCT05412004 | 6.4 | Study Intervention Compliance | 6.4. Study Intervention Compliance A record of the number of single-dose pens dispensed to and taken by each participant must be maintained and reconciled with study intervention and compliance records. Intervention start and stop dates, including dates for intervention delays and/or dose reductions will also be record... | [] |
NCT05412004 | 6.5 | Dose Modification | 6.5. Dose Modification Dose modification is permitted for management of intolerable GI symptoms during the first 24 weeks of the treatment period (Section [6.5.1\)](#page-40-2). Participants who do not tolerate at least 10 mg even after the described measures, including 1 deescalation and re-escalation attempt, will be... | [] |
NCT05412004 | 6.5.1 | Management of Participants with Gastrointestinal Symptoms | 6.5.1. Management of Participants with Gastrointestinal Symptoms In participants who experience intolerable GI symptoms (for example, nausea, vomiting, or diarrhea) at any time during the study, the following measures are recommended: - counselling on dietary behaviors that may help mitigate nausea and vomiting, (for e... | [
"Participants who tolerate"
] |
NCT05412004 | 6.6 | Continued Access to Study Intervention after the End of the Study | 6.6. Continued Access to Study Intervention after the End of the Study Tirzepatide will not be made available to participants after conclusion of the study. | [] |
NCT05412004 | 6.7 | Treatment of Overdose | 6.7. Treatment of Overdose Study intervention overdose (more than the specified number of injections in less than 72 hours) will be reported as an AE. In the event of an overdose, the treating physician should: - Contact the medical monitor immediately. - Evaluate the participant to determine, in consultation with the ... | [] |
NCT05412004 | 6.8 | Concomitant Therapy | 6.8. Concomitant Therapy Participants will be permitted to use concomitant medications that they require during the study, except certain medications (Section [6.8.2\)](#page-43-0) that may interfere with the assessment of efficacy and safety characteristics of the study treatments. Investigative-site staff will inform... | [] |
NCT05412004 | 6.8.1 | Management of Incident Diabetes | 6.8.1. Management of Incident Diabetes Incident diabetes is defined when any 1 of the following occur after randomization (American Diabetes Association 2020): - unequivocal hyperglycemia (random glucose ≥200 mg/dL) with signs or symptoms of hyperglycemia - within a 4-week period, any 2 of the following criteria are ob... | [] |
NCT05412004 | 6.8.2 | Prohibited Concomitant Medications | 6.8.2. Prohibited Concomitant Medications The following medications are prohibited during the study: - DPP-4 inhibitors - Open-label GLP-1R agonists - Stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine, dextroamphetamine, dexmethylphenidate, methylphenidate, and lisdexamfetamine) - m... | [
"In addition,"
] |
NCT05412004 | 7 | Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal | 7. Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal Discontinuation of specific sites or of the study as a whole are handled as part of Section [10.1,](#page-69-1) Appendix 1. | [] |
NCT05412004 | 7.1 | Discontinuation of Study Intervention | 7.1. Discontinuation of Study Intervention When necessary, a participant may be permanently discontinued from study intervention. If so, the participant will remain in the study and follow procedures for remaining study visits, as shown in the SoA. A participant who prematurely discontinues study intervention is strong... | [
"participant decision",
"clinical considerations"
] |
NCT05412004 | 7.1.1 | Liver Chemistry Stopping Criteria | 7.1.1. Liver Chemistry Stopping Criteria The study intervention should be interrupted or discontinued if one or more of these conditions occur: | Elevation | Exception | |-----------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT05412004 | 7.1.2 | Temporary Discontinuation | 7.1.2. Temporary Discontinuation In certain situations, after randomization, the investigator may need to temporarily interrupt study intervention. Every effort should be made by the investigator to maintain participants on study intervention and to restart study intervention after any temporary interruption, as soon a... | [] |
NCT05412004 | 7.2 | Participant Discontinuation/Withdrawal from the Study | 7.2. Participant Discontinuation/Withdrawal from the Study Discontinuation is expected to be uncommon. A participant may withdraw from the study: - at any time at the participant's own request - at the request of the participant's designee (for example, parents or legal guardian) - a participant will be withdrawn from ... | [] |
NCT05412004 | 7.3 | Lost to Follow up | 7.3. Lost to Follow up A participant will be considered lost to follow-up if he or she repeatedly fails to return for scheduled visits and is unable to be contacted by the study site. Site personnel or designee are expected to make diligent attempts to contact participants who fail to return for a scheduled visit or we... | [] |
NCT05412004 | 8 | Study Assessments and Procedures | 8. Study Assessments and Procedures Study procedures and their timing are summarized in the SoA. Immediate safety concerns should be discussed with the sponsor immediately upon occurrence or awareness to determine if the participant should continue or discontinue study intervention. Adherence to the study design requir... | [] |
NCT05412004 | 8.1 | Efficacy Assessments | 8.1. Efficacy Assessments | [] |
NCT05412004 | 8.1.1 | Primary Efficacy Assessment | 8.1.1. Primary Efficacy Assessment | [] |
NCT05412004 | 8.1.1.1 | Polysomnography | 8.1.1.1. Polysomnography The primary efficacy assessment in this study is AHI. AHI measurements will be collected via polysomnography. Polysomnography assessments (including AHI, blood oxygen saturation parameters, PR, sleep parameters) will be performed during 1-night, overnight clinic stays, per the SoA. Data from th... | [] |
NCT05412004 | 8.1.2 | Secondary Efficacy Assessments | 8.1.2. Secondary Efficacy Assessments | [] |
NCT05412004 | 8.1.2.1 | Patient-Reported Outcomes | 8.1.2.1. Patient-Reported Outcomes | [] |
NCT05412004 | 8.1.2.1.1 | Functional Outcomes of Sleep Questionnaire (FOSQ) | 8.1.2.1.1. Functional Outcomes of Sleep Questionnaire (FOSQ) The FOSQ will be included to assess change in FOSQ domains and total score from baseline to Week 52. The FOSQ is a 30-item sleep-specific, participant-completed questionnaire used to assess the effect of disorders associated with excessive daytime sleepiness ... | [] |
NCT05412004 | 8.1.2.1.2 | PROMIS Short Form v1.0 Sleep-related Impairment 8a | 8.1.2.1.2. PROMIS Short Form v1.0 Sleep-related Impairment 8a The PROMIS Short Form v1.0 Sleep-related Impairment 8a assesses self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments associated with sleep problems or impaired alertness. The PR... | [] |
NCT05412004 | 8.1.2.1.3 | PROMIS Short Form v1.0 Sleep Disturbance 8b | 8.1.2.1.3. PROMIS Short Form v1.0 Sleep Disturbance 8b The PROMIS Short Form v1.0 Sleep Disturbance 8b assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep, including perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of... | [] |
NCT05412004 | 8.1.2.1.4 | Epworth Sleepiness Scale | 8.1.2.1.4. Epworth Sleepiness Scale The ESS will be included to assess improvements in excessive daytime sleepiness from baseline to Week 52. The ESS is an 8-item participant-completed measure that asks the participant to rate on a scale of 0 (would never doze) to 3 (high chance of dozing), their usual chances of dozin... | [] |
NCT05412004 | 8.1.2.1.5 | Short-Form 36 Version 2 Health Survey, Acute Form, 1-week Recall Version | 8.1.2.1.5. Short-Form 36 Version 2 Health Survey, Acute Form, 1-week Recall Version The SF-36v2 will be included to assess health-related quality of life from baseline to Week 52. The SF-36v2 acute form, 1-week recall version is a 36-item generic, participant-completed measure designed to assess the following 8 domains... | [] |
NCT05412004 | 8.1.2.1.6 | Patient Global Impression of Status – Obstructive Sleep Apnea (PGIS-OSA) Symptoms Scales | 8.1.2.1.6. Patient Global Impression of Status – Obstructive Sleep Apnea (PGIS-OSA) Symptoms Scales Three patient global impression of status scales will be included to assess categorical shift in participant self-rated assessment of their OSA symptom severity from baseline to Week 52.
PGIS-OSA Fatigue This is a singl... | [
"PGIS-OSA Fatigue",
"PGIS-OSA Sleepiness",
"PGIS-OSA Snoring"
] |
NCT05412004 | 8.1.3 | Exploratory Efficacy Assessments | 8.1.3. Exploratory Efficacy Assessments | [] |
NCT05412004 | 8.1.3.1 | Actigraphy | 8.1.3.1. Actigraphy The actigraphy device (AX6) will be utilized in the OSA trial to objectively evaluate the effect of tirzepatide on various sleep and physical activity parameters including but not limited to change of daytime sleep time, sleep efficiency, and change in daytime physical activity from baseline. The ac... | [] |
NCT05412004 | 8.1.3.2 | Patient Global Impression of Change – Obstructive Sleep Apnea (PGIC-OSA) Symptoms Scales | 8.1.3.2. Patient Global Impression of Change – Obstructive Sleep Apnea (PGIC-OSA) Symptoms Scales Four patient global impression of change scales will be included to assess categorical shift in participant self-rated assessment of change in their OSA symptom severity from baseline to Week 52.
PGIC-OSA Fatigue This is ... | [
"PGIC-OSA Fatigue",
"PGIC-OSA Sleepiness",
"PGIC-OSA Sleep Quality",
"PGIC-OSA Snoring"
] |
NCT05412004 | 8.1.3.3 | EQ-5D-5L | 8.1.3.3. EQ-5D-5L The EQ-5D-5L (EuroQol Research Foundation 2019) is a standardized 5-item self-administered instrument for use as a measure of health outcome. It provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as w... | [] |
NCT05412004 | 8.2 | Safety Assessments | 8.2. Safety Assessments Planned time points for all safety assessments are provided in the SoA. | [] |
NCT05412004 | 8.2.1 | Physical Examinations | 8.2.1. Physical Examinations A complete physical examination will include, at a minimum, assessments of the CV, respiratory, gastrointestinal and neurological systems as well as a thyroid examination. Height, weight, and waist circumference will also be measured and recorded. A symptom-directed physical assessment will... | [] |
NCT05412004 | 8.2.2 | Vital Signs | 8.2.2. Vital Signs For each participant, vital signs measurements should be conducted according to the SoA (Section [1.3\)](#page-14-0). | [] |
NCT05412004 | 8.2.3 | Electrocardiograms (ECG) | 8.2.3. Electrocardiograms (ECG) Single 12-lead ECG will be obtained as outlined in the SoA (see Section [1.3\)](#page-14-0) using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. A local single 12-lead ECG will be collected at designated visits. ECGs should be col... | [] |
NCT05412004 | 8.2.4 | Clinical Safety Laboratory Tests | 8.2.4. Clinical Safety Laboratory Tests See Section [10.2,](#page-76-0) Appendix 2 for the list of clinical laboratory tests to be performed and the SoA for the timing and frequency. The investigator must review the laboratory results, document this review, and report any clinically relevant changes occurring during th... | [] |
NCT05412004 | 8.2.5 | Pregnancy Testing | 8.2.5. Pregnancy Testing See the SoA (Section [1.3\)](#page-14-0) for testing for pregnancy and timepoints. See Appendix 4 (Section [10.4\)](#page-88-0) for additional information for pregnancy. | [] |
NCT05412004 | 8.2.6 | Suicidal Ideation and Behavior Risk Monitoring | 8.2.6. Suicidal Ideation and Behavior Risk Monitoring Patients with obesity may occasionally develop suicidal ideation or behavior. Participants should be monitored appropriately and observed closely for SIB or any other unusual changes in behavior, especially at the beginning and end of the course of intervention, or ... | [] |
NCT05412004 | 8.2.6.1 | C-SSRS | 8.2.6.1. C-SSRS Columbia Suicide-Severity Rating Scale (C-SSRS) is a scale that captures the occurrence, severity, and frequency of suicidal ideation and behavior during the assessment period via a questionnaire. The scale was developed by the National Institute of Mental Health (NIMH) trial group (TASA) for the purpos... | [] |
NCT05412004 | 8.2.6.2 | PHQ-9 | 8.2.6.2. PHQ-9 The PHQ-9 is a validated self-report screening tool that assesses the presence and intensity of depressive symptoms. The PHQ-9, which incorporates the 9 Diagnostic and Statistical Manual-IV depression criteria as "0" (not at all) to "3" (nearly every day), was developed for use in primary care settings (... | [] |
NCT05412004 | 8.3 | Adverse Events, Serious Adverse Events, and Product Complaints | 8.3. Adverse Events, Serious Adverse Events, and Product Complaints The definitions of the following events can be found in Section [10.3,](#page-80-0) Appendix 3: - AEs - SAEs - PCs These events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorize... | [] |
NCT05412004 | 8.3.1 | Timing and Mechanism for Collecting Events | 8.3.1. Timing and Mechanism for Collecting Events This table describes the timing, deadlines, and mechanism for collecting events. | Event | CollectionStart | CollectionStop | Timing for Reportingto Sponsor orDesignee | Mechanism forReporting | Back-UpMethod ofReporting | |-------|-----------------------|--------------... | [] |
NCT05412004 | 8.3.1.1 | Adverse Event Monitoring with a Systematic Questionnaire | 8.3.1.1. Adverse Event Monitoring with a Systematic Questionnaire Nonleading AE collection should occur prior to the collection of the C-SSRS and PHQ-9, if AE and C-SSRS/PHQ-9 collections done on the same day. If a suicide-related event is discovered during the C-SSRS or PHQ-9 but was not captured during the nonleading... | [] |
NCT05412004 | 8.3.2 | Pregnancy | 8.3.2. Pregnancy
Collection of pregnancy information Male participants with partners who become pregnant - The investigator will attempt to collect pregnancy information on any male participant's female partner who becomes pregnant while the male participant is in this study. This applies only to male participants who... | [
"Collection of pregnancy information",
"Female participants who become pregnant"
] |
NCT05412004 | 8.3.3 | Adverse Events of Special Interest | 8.3.3. Adverse Events of Special Interest Adverse events of special interest are prospectively defined to include - severe hypoglycemia - MACE (adjudicated); includes, but not limited to CV death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina, and hospitalization for heart failure - treatment-emerge... | [] |
NCT05412004 | 8.4 | Pharmacokinetics | 8.4. Pharmacokinetics Blood samples will be obtained from all participants enrolled in the 2 ISAs to enable the characterization of tirzepatide PK and exposure response relationships, as permissible. Samples will be collected with concurrent immunogenicity samples at timepoints indicated in the SoA (Section [1.3\)](#pa... | [] |
NCT05412004 | 8.4.1 | Bioanalytical Methods | 8.4.1. Bioanalytical Methods Samples will be analyzed at a laboratory approved by the sponsor, and stored at a facility designated by the sponsor. Concentrations of tirzepatide will be assayed using a validated liquid chromatography mass spectrometry method. Analyses of samples collected from placebo-treated participan... | [] |
NCT05412004 | 8.5 | Pharmacodynamics | 8.5. Pharmacodynamics Samples to assess the PD properties of tirzepatide are included in the efficacy measures and not applicable in this section. | [] |
NCT05412004 | 8.6 | Genetics | 8.6. Genetics A whole blood sample will be collected for pharmacogenetic analysis where local regulations allow. | [] |
NCT05412004 | 8.7 | Biomarkers | 8.7. Biomarkers Blood samples will be collected to address questions of relevance to drug disposition, target engagement, PD, mechanism of action, variability of study participant response (including safety), and clinical outcome. Biomarkers will include measurement of biomolecules including proteins, lipids, and other... | [] |
NCT05412004 | 8.8 | Immunogenicity Assessments | 8.8. Immunogenicity Assessments At the visits and times specified in the SoA (Section [1.3\)](#page-14-0), venous blood samples will be collected for analysis to determine antibody production against tirzepatide. Antibodies may be further characterized for: cross-reactive binding to native GIP and GLP-1, neutralizing a... | [] |
NCT05412004 | 8.9 | Health Economics OR Medical Resource Utilization and Health Economics | 8.9. Health Economics OR Medical Resource Utilization and Health Economics Health economics or medical resource utilization and health economics parameters are not evaluated in this study. | [] |
NCT05412004 | 9 | Statistical Considerations | 9. Statistical Considerations This section is a summary of the planned statistical analyses of the most important endpoints, including primary and key secondary endpoints. The SAP will include more technical and detailed description of the statistical analyses described in this section. Unblinding details will be speci... | [] |
NCT05412004 | 9.1 | Statistical Hypotheses | 9.1. Statistical Hypotheses For each ISA, the primary objective is to demonstrate that tirzepatide at the MTD (10 mg or 15 mg) is superior to Placebo in treating participants with OSA with respect to AHI endpoint. Thus the null and alternative hypotheses will be defined as below. Null hypothesis: tirzepatide at the MTD... | [] |
NCT05412004 | 9.1.1 | Multiplicity Adjustment | 9.1.1. Multiplicity Adjustment The statistical comparisons for the primary efficacy endpoint and the key secondary endpoints will be carried out based on a graphical approach for multiple comparisons within each ISA (Bretz et al. 2011). The graphical approach is a closed testing procedure; hence, it strongly controls t... | [] |
NCT05412004 | 9.2 | Analyses Sets | 9.2. Analyses Sets This table describes the populations that will be used for statistical analyses within each ISA of the master protocol. Additional intervention-specific populations for analyses may be described in the respective ISA. | Analysis Set or Population | Description | |----------------------------|--------... | [] |
NCT05412004 | 9.3 | Statistical Analyses | 9.3. Statistical Analyses | [] |
NCT05412004 | 9.3.1 | General Considerations | 9.3.1. General Considerations Statistical analysis will be the responsibility of the sponsor or its designee. Statistical analysis for each ISA will be conducted individually and a combined analysis with both ISAs is not planned. The SAP will be finalized prior to the unblinding of the first ISA. Changes to the data an... | [] |
NCT05412004 | 9.3.2 | Primary Analysis | 9.3.2. Primary Analysis The primary objective of this study is to test the hypothesis that tirzepatide at the MTD (10 mg or 15 mg) is superior to placebo for participants with moderate to severe OSA on the mean AHI reduction from baseline to Week 52. The primary analysis guided by the "treatment regimen" estimand will ... | [] |
NCT05412004 | 9.3.3 | Analysis of Key Secondary Endpoints | 9.3.3. Analysis of Key Secondary Endpoints The analyses for key secondary endpoints as in Section [3](#page-26-0) will be performed for both the "treatment regimen" and "efficacy" estimand as described in Section [9.3.1](#page-62-1) using the graphical testing scheme. The details of graphical testing scheme will be des... | [] |
NCT05412004 | 9.3.4 | Treatment Group Comparability | 9.3.4. Treatment Group Comparability | [] |
NCT05412004 | 9.3.4.1 | Participant Disposition | 9.3.4.1. Participant Disposition Participants who discontinue from the study will be identified, and the extent of their participation in the study will be reported for each ISA. A detailed description of participant disposition and the reasons for discontinuation will be summarized by treatment group for each ISA at t... | [] |
NCT05412004 | 9.3.4.2 | Participant Characteristics | 9.3.4.2. Participant Characteristics Participant characteristics and baseline clinical measures will be summarized for each treatment . For all participant characteristics, the summaries will include descriptive statistics for continuous measures (for example, sample size, mean, standard deviation, median, minimum, and... | [] |
NCT05412004 | 9.3.4.3 | Concomitant Therapy | 9.3.4.3. Concomitant Therapy Concomitant medications used during the study will be summarized for each ISA. | [] |
NCT05412004 | 9.3.5 | Safety Analyses | 9.3.5. Safety Analyses Unless specified otherwise, safety assessments will compare safety of tirzepatide at the MTD (10 mg or 15 mg) with placebo irrespective of adherence to study intervention. Thus, safety analyses will be conducted using the SS. | [] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.