protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04712669 | 6.3.1 | Investigational Product Packaging and Labeling | 6.3.1. Investigational Product Packaging and Labeling IP will be packaged in an appropriately sized bottle and labeled per local regulations. | [] |
NCT04712669 | 6.3.2 | Investigational Product Storage | 6.3.2. Investigational Product Storage IP is to be stored at 15°C to 25°C (59°F to 77°F) in a dry place and protected from light. | [] |
NCT04712669 | 6.3.3 | Investigational Product Administration | 6.3.3. Investigational Product Administration Once a patient is confirmed as eligible for study participation, the patient will be randomized via the IRT and assigned a kit(s) of IP. For each scheduled visit, the patient will be assigned new IP kit(s). | [] |
NCT04712669 | 6.3.4 | Investigational Product Accountability | 6.3.4. Investigational Product Accountability Accountability for the IP is the responsibility of the Investigator. The study site must maintain accurate records including what kits were received and date, to whom the IP was dispensed, and all accounts of IP that is lost/missing or discarded. Additional details will be ... | [] |
NCT04712669 | 6.3.5 | Investigational Product Handling and Disposal | 6.3.5. Investigational Product Handling and Disposal Patients should return all IP (including empty, partial, and full bottles) at their regularly scheduled clinic visits. Reconciliation of all IP that was dispensed, returned, or lost must be accounted for with documentation for any IP that was lost or missing. Returne... | [] |
NCT04712669 | 6.4 | Measures to Minimize Bias: Randomization and Blinding | 6.4. Measures to Minimize Bias: Randomization and Blinding This is a double-blind study. The Sponsor, Investigator, patient, and study site personnel will be blinded to all treatment group assignments. The Investigator will have the ability, in the IRT system, to unblind a patient, and the decision will reside solely w... | [
"Blind Break (IVRS/IWRS)"
] |
NCT04712669 | 6.5 | Investigational Product Compliance | 6.5. Investigational Product Compliance Patient compliance with IP will be assessed at each visit by the site/study staff. Compliance will be assessed by direct questioning of the patient and counting returned tablets at each study visit to the study site. Patients will be reminded of the importance of taking their IP ... | [] |
NCT04712669 | 6.6 | Concomitant Therapy | 6.6. Concomitant Therapy Any medication or vaccine (including over-the-counter or prescription medicines, vitamins, and/or herbal supplements) that the patient received in the 8 weeks prior to enrollment, is receiving at the time of enrollment, or receives during the study must be recorded along with: - x Reason for us... | [] |
NCT04712669 | 6.6.1 | Rodatristat-Drug Interaction Potential | 6.6.1. Rodatristat-Drug Interaction Potential In vitro experiments and in silico modeling to evaluate the drug-drug interaction potential of rodatristat ethyl and rodatristat have not identified any moderate or high risks for potential drug-drug interactions (IB, 2020). There is the potential for weak interactions with... | [
"No concomitant medications based on these in vitro and clinical findings are prohibited."
] |
NCT04712669 | 6.6.2 | Pulmonary Arterial Hypertension Medications | 6.6.2. Pulmonary Arterial Hypertension Medications The target population of patients with PAH will be receiving SOC treatment which can consist of monotherapy, dual, or triple combination therapy that have been taken for at least 12 weeks prior to the Screening RHC. These medications should be prescribed at doses consi... | [] |
NCT04712669 | 6.6.3 | Prohibited Medications and Supplements | 6.6.3. Prohibited Medications and Supplements The following drugs are prohibited: - x Drugs which are known to prolong QT and which are also clearly associated with a known risk for Torsades de Pointe (per www.CredibleMeds.org (Woosley, 2019), Refer to Appendix 1). - x MAOIs - x Telotristat ethyl - x 5-HTP or L-tryptop... | [] |
NCT04712669 | 7 | INTERVENTION AFTER THE END OF THE STUDY – OPEN-LABEL EXTENSION | 7. INTERVENTION AFTER THE END OF THE STUDY – OPEN-LABEL EXTENSION | [] |
NCT04712669 | 7.1 | Rationale for the Open-Label Extension | 7.1. Rationale for the Open-Label Extension The purpose of the OLE is to provide continuous, uninterrupted access to rodatristat ethyl for patients who participated in the main part of this study if the patient appears to benefit from the therapy (as determined by Investigator and patient). The OLE will also provide ac... | [] |
NCT04712669 | 7.2 | Objective | 7.2. Objective x To evaluate the long-term safety, tolerability, and efficacy of rodatristat ethyl in patients with PAH | [] |
NCT04712669 | 7.3 | Endpoints | 7.3. Endpoints | [] |
NCT04712669 | 7.3.1 | Safety endpoints | 7.3.1. Safety endpoints - x The proportion of patients who discontinue rodatristat ethyl due to an AE - x The proportion of patients with SAEs - x The proportion of patients with AEs - x The proportion of patients with treatment-emergent Grade 3 or 4 AEs - x The proportion of patients with treatment-emergent Grade 3 or... | [] |
NCT04712669 | 7.3.2 | Efficacy endpoints | 7.3.2. Efficacy endpoints - x Change in PVR - x Change in cardiac index, mPAP, mRAP, SvO2 at rest and PAC from baseline - x Time to Clinical Worsening - x Death from any cause - x Change in WHO FC from baseline - x Change in 6MWD from baseline - x Change in NT-proBNP from baseline - x Changes in right atrial size and R... | [] |
NCT04712669 | 7.4 | Open-Label Extension Design | 7.4. Open-Label Extension Design Patients in the Main Study that do not discontinue prematurely and complete up to and including the Week 24 Visit, have the option to rollover into the OLE. Patients who continue into the OLE will be blinded to the treatment they received in the Main Study. Patients who received active ... | [] |
NCT04712669 | 7.5 | Number of Patients and Inclusion/Exclusion Criteria | 7.5. Number of Patients and Inclusion/Exclusion Criteria The maximum number of patients enrolled into the OLE will be the number of patients who complete the Main Study (Week 24). | [] |
NCT04712669 | 7.6 | Inclusion Criteria | 7.6. Inclusion Criteria - 1. Patient must have completed study assessments and procedures up to and including Week 24 in the Main Study. - 2. Female patients of childbearing potential must have a negative serum or urine pregnancy test at the Week 24 visit and must agree to use contraception as detailed in Section 5.4.1... | [] |
NCT04712669 | 7.7 | Exclusion Criteria | 7.7. Exclusion Criteria - 1. Patients who have demonstrated noncompliance with study visits or IP in the Main Study. - 2. Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery. - 3. New major thrombo-embolic events developed after completion of the M... | [] |
NCT04712669 | 7.8 | Open-Label Extension Procedures | 7.8. Open-Label Extension Procedures All assessments in the OLE will be performed as explained in the Main Study. SoA for the OLE are in Section 1.4 and Section 1.5. Patients rolling into the OLE will complete the Screening/Enrollment Visit after their final visit in the Main Study (Week 24). All procedures for Week 24... | [] |
NCT04712669 | 7.9 | Open-Label Extension Treatment Assignment | 7.9. Open-Label Extension Treatment Assignment At the Screening/Enrollment Visit of the OLE, eligible patients who received placebo during the main study will be randomly allocated (1:1) to one of the following 2 treatment groups: | TreatmentArmName | TreatmentDescription | |---------------------------------|----------... | [] |
NCT04712669 | 7.10 | Investigational Product Preparation, Handling, Storage, and Accountability | 7.10. Investigational Product Preparation, Handling, Storage, and Accountability All IP preparation, handling, storage, and accountability will be the same as in the Main Study as in Section 6. | [] |
NCT04712669 | 7.11 | Dose Adjustment Criteria | 7.11. Dose Adjustment Criteria Dose adjustment criteria are the same as the Main Study and can be found in Section 6. | [] |
NCT04712669 | 7.12 | Criteria for Investigational Product/Study Termination | 7.12. Criteria for Investigational Product/Study Termination All criteria for IP and study termination are the same as in the Main Study and can be found in Section 8. | [] |
NCT04712669 | 8 | DISCONTINUATION OF INVESTIGATIONAL PRODUCT AND PATIENT DISCONTINUATION/WITHDRAWAL | 8. DISCONTINUATION OF INVESTIGATIONAL PRODUCT AND PATIENT DISCONTINUATION/WITHDRAWAL Unnecessary withdrawal of patients should be avoided, and all efforts should be made to retain patients in the study. | [] |
NCT04712669 | 8.1 | Discontinuation of Investigational Product | 8.1. Discontinuation of Investigational Product The Medical Monitor should be notified of any change to background PAH therapy to determine any need for withdrawal. See Section 8.2 for study withdrawal procedures. Patients meeting any of the following liver chemistry criteria must be withdrawn (IP should be discontinue... | [] |
NCT04712669 | 8.1.1 | Temporary Discontinuation | 8.1.1. Temporary Discontinuation Temporary discontinuation of IP of up to 7 days will be allowed for extenuating circumstances or to manage AEs. | [] |
NCT04712669 | 8.2 | Patient Discontinuation/Withdrawal from the Study | 8.2. Patient Discontinuation/Withdrawal from the Study Patients may withdraw from the study at any time at his/her own request or may be withdrawn at any time at the discretion of the Investigator for safety, behavioral, compliance, or administrative reasons. This is expected to be uncommon. If the patient withdraws co... | [] |
NCT04712669 | 8.2.1 | Investigational Product Discontinuation | 8.2.1. Investigational Product Discontinuation If a patient is permanently discontinued from the IP, but agrees to study visits, the patient will come in for the Early Termination Visit and continue attending clinic visits as scheduled through the 24-week visit (from first dose). A final follow-up visit will not be req... | [] |
NCT04712669 | 8.2.2 | Study Discontinuation | 8.2.2. Study Discontinuation If a patient who discontinues IP decides to end all study participation, an Early Termination Visit should be conducted, as shown in the SoA (Section 1.3), if possible. Patients who withdraw should be asked if they may be contacted by the study site by telephone unless they explicitly withd... | [] |
NCT04712669 | 8.3 | Lost to Follow up | 8.3. Lost to Follow up A patient 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. The following actions must be taken if a patient fails to return to the clinic for a required study visit: - x The site must attempt to cont... | [
"Altavant Sciences GmbH Effective: 19JAN2022"
] |
NCT04712669 | 9 | STUDY ASSESSMENTS AND PROCEDURES | 9. STUDY ASSESSMENTS AND PROCEDURES Study procedures and their timing are summarized in the SoA in Section 1.3 for the Main Study and in Section 1.4 and Section 1.5 for the OLE. Safety concerns should be discussed with the Sponsor immediately upon occurrence or awareness to determine if the patient should continue or d... | [] |
NCT04712669 | 9.1 | Efficacy Assessments | 9.1. Efficacy Assessments The efficacy-related assessments, as outlined below, will be obtained at time points indicated in the SoA in Section 1.3 and Section 1.4. | [] |
NCT04712669 | 9.1.1 | Right Heart Catheterization | 9.1.1. Right Heart Catheterization The RHC is a common procedure used to diagnose PAH. Cardiopulmonary hemodynamics will be assessed by RHC. All required RHC parameters must be collected using the same methods at Screening/Randomization and Week 24. The Screening/Randomization RHC will be required to confirm the diagno... | [] |
NCT04712669 | 9.1.2 | Time to Clinical Improvement | 9.1.2. Time to Clinical Improvement TTCI will be evaluated by a multicomponent improvement score including WHO FC and 6MWT measurements: a > 10% increase in 6MWD or 30 meters AND an improvement to or maintenance of WHO FC II symptomatology, in the absence of a deterioration in clinical condition or death during the 24 ... | [] |
NCT04712669 | 9.1.3 | Time to Clinical Worsening | 9.1.3. Time to Clinical Worsening TTCW is defined as the first occurrence of a composite end point of: 1. Death from any cause, 2. Hospitalization for worsening PAH (any hospitalization for worsening PAH, lung or heart and lung transplantation, atrial septostomy, or initiation of parenteral prostanoid therapy), 3. Dise... | [] |
NCT04712669 | 9.1.4 | Six-Minute Walk Test/Six-Minute Walk Distance | 9.1.4. Six-Minute Walk Test/Six-Minute Walk Distance The 6MWT is a simple, commonly used, standardized measure of functional exercise capacity and endurance. It is a commonly used measure of efficacy in PAH clinical studies. The change from baseline in 6MWD following intervention indicates symptomatic improvement over ... | [] |
NCT04712669 | 9.1.5 | Echocardiography | 9.1.5. Echocardiography Patients will undergo resting cardiac echocardiography at specified visits. Echocardiographic endpoints will include right atrial size and measures of RV function (TAPSE, tricuspid annular systolic velocity, and RV fractional area change). There will be a core imaging laboratory for centralized ... | [] |
NCT04712669 | 9.1.6 | Pulmonary Function Tests (PFTs) | 9.1.6. Pulmonary Function Tests (PFTs) PFTs (performed with or without bronchodilation) should be completed at Screening if there are no historical results from tests completed within 24 weeks prior to Screening. | [] |
NCT04712669 | 9.1.7 | World Health Organization Functional Class | 9.1.7. World Health Organization Functional Class PAH functional disease severity is classified according to WHO FC. Patients are classified into 1 of 4 functional classes on the basis of their degree of physical limitation and associated symptoms. Refer to Appendix 7 for full description of each Functional Class. | [] |
NCT04712669 | 9.1.8 | N-terminal pro-Brain Natriuretic Peptide Level | 9.1.8. N-terminal pro-Brain Natriuretic Peptide Level NT-proBNP is a strong predictor of disease progression and mortality in PAH patients. Current PAH treatment guidelines recommend measurement of NT-proBNP levels for both risk assessment and longitudinal follow up. NT-proBNP levels are also a good marker of response ... | [] |
NCT04712669 | 9.1.9 | Pulmonary Arterial Hypertension-Symptoms and Impact Questionnaire | 9.1.9. Pulmonary Arterial Hypertension-Symptoms and Impact Questionnaire The PAH SYMPACT Questionnaire is the first instrument for quantifying PAH symptoms and impacts. It is a brief, disease-specific patient-reported outcome (PRO) instrument possessing good psychometric properties. The questionnaire consists of two pa... | [] |
NCT04712669 | 9.1.10 | Registry to Evaluate Early and Long-term Pulmonary Arterial Hypertension Disease Management Lite 2 Risk Assessment Calculator | 9.1.10. Registry to Evaluate Early and Long-term Pulmonary Arterial Hypertension Disease Management Lite 2 Risk Assessment Calculator REVEAL Lite 2 includes 6 non-invasive variables: FC, vital signs (SBP and HR), 6MWD, NT-proBNP, and renal insufficiency (by eGFR). REVEAL Lite 2 will be a calculated parameter (by statis... | [] |
NCT04712669 | 9.1.11 | Actigraphy | 9.1.11. Actigraphy Data on physical activity will be collected using a small wrist-worn physical activity tracker (monitor designed for documenting physical movement) that will transmit all activity through the 24 weeks of the Main Study. | [] |
NCT04712669 | 9.2 | Safety Assessments | 9.2. Safety Assessments | [] |
NCT04712669 | 9.2.1 | Pregnancy Testing | 9.2.1. Pregnancy Testing Serum pregnancy tests will be obtained for all female patients of childbearing potential at Screening and every 4 weeks while on IP. Urine pregnancy tests will be obtained at all subsequent visits and must be confirmed negative at the Baseline Visit before randomization and IP dispensation. Add... | [] |
NCT04712669 | 9.2.2 | Physical Examinations | 9.2.2. Physical Examinations A complete physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal and neurological systems. Height (only at Screening) and weight will also be measured and recorded. Investigators should pay special attention to clinical signs relat... | [] |
NCT04712669 | 9.2.3 | Vital Signs | 9.2.3. Vital Signs Vital signs will be measured after 5 minutes rest and will include temperature, systolic and diastolic blood pressure, respiration rate and oxygen saturation. | [] |
NCT04712669 | 9.2.4 | Electrocardiograms | 9.2.4. Electrocardiograms Three 12-lead ECGs, one minute apart, will be obtained after at least 5 minutes of rest at Baseline. Single 12-lead ECGs will be performed at all other time points. Each ECG performed during the study will be obtained using an ECG machine that automatically calculates the HR and measures PR, Q... | [] |
NCT04712669 | 9.2.5 | Clinical Safety Laboratory Assessments | 9.2.5. Clinical Safety Laboratory Assessments A central laboratory will be used for clinical safety laboratory assessments. The details for sample collection, preparation, and shipping to the central laboratory will be provided in a separate lab manual. Reference ranges for all safety parameters will be provided to the... | [] |
NCT04712669 | 9.2.5.1 | Hematology | 9.2.5.1. Hematology | HematologyPanel | | | | |------------------------|----------------------------------|---------------|--| | Platelet Count | Red Blood Cell (RBC)Indices: | Automated WBC | | | | | Differential: | | | RBC Count | Mean Corpuscular Volume | Neutrophils | | | | (MCV) | | | | White Blood Cell (WBC) | Me... | [] |
NCT04712669 | 9.2.5.2 | Coagulation | 9.2.5.2. Coagulation | Coagulation Panel | |----------------------------------------------| | Prothrombin Time (PT) | | INR | | Activated Partial Thromboplastin Time (aPTT) | Coagulation testing will be done at Screening, Week 12, and Week 24 for all patients on the Main Study and at Weeks 12 and 24 during the OLE in t... | [] |
NCT04712669 | 9.2.5.3 | Clinical Chemistry | 9.2.5.3. Clinical Chemistry | | Clinical Chemistry Panel | | | | |---------------|--------------------------|--------------------------------------|---------------|--| | BloodUrea | Potassium | ALT | Albumin | | | Nitrogen | | | | | | Creatinine | Chloride | Gamma-Glutamyl Transferase | Total Protein | | | | | (GGT) | ... | [] |
NCT04712669 | 9.2.5.4 | Urinalysis | 9.2.5.4. Urinalysis
Urinalysis Bilirubin, Glucose, Protein, Blood and Ketones, Leukocytes, Nitrites, pH, Specific Gravity and Urobilinogen by dipstick Microscopic examination (if blood or protein is abnormal) Microbiology (at discretion of Investigator based on urinalysis results) | [
"Urinalysis"
] |
NCT04712669 | 9.2.5.5 | Other Tests | 9.2.5.5. Other Tests
Other Tests NT-proBNP Urine Creatinine (for calculation of 5-HIAA) at each 5-HIAA collection time Estimated Glomerular Filtration Rate (eGFR) FSH (as needed at Screening for confirmation of postmenopausal status) Serum beta-hCG (pregnancy test; only at Screening) Human Chorionic Gonadotropin (hCG)... | [
"Other Tests"
] |
NCT04712669 | 9.2.6 | Pharmacogenetic Testing | 9.2.6. Pharmacogenetic Testing A separate and specific informed consent form will be provided to patients to allow the sponsor to obtain and test a patient's blood sample taken at the Baseline/Day1 and the Week 24 visits for pharmacogenetic markers that may be predictive of the natural history of the disease, response ... | [] |
NCT04712669 | 9.2.7 | Optional Blood Sample for Future Research | 9.2.7. Optional Blood Sample for Future Research In addition to the study-specific informed consent to be signed by each patient participating in the study, a separate, specific signature will be required to document a patient's agreement to provide additional samples or to allow the use of the remainder of their alrea... | [] |
NCT04712669 | 9.2.8 | Suicidal Ideation and Behavior Risk Monitoring | 9.2.8. Suicidal Ideation and Behavior Risk Monitoring Rodatristat ethyl acts to decrease peripheral 5-HT levels and it was designed to not cross the blood-brain barrier; therefore, CNS 5-HT levels are not expected to be significantly impacted. However, patients being treated with IP should be monitored appropriately an... | [] |
NCT04712669 | 9.2.8.1 | Columbia Suicide Severity Rating Scale | 9.2.8.1. Columbia Suicide Severity Rating Scale The C-SSRS is a valid, reliable, evidenced-based suicidal ideation and behavior rating scale, which was developed by multiple institutions, including Columbia University with National Institute of Mental Health support, to evaluate suicide risk (CLP, 2016). The rater-/cli... | [] |
NCT04712669 | 9.2.8.2 | Hospital Anxiety and Depression Scale | 9.2.8.2. Hospital Anxiety and Depression Scale The HADS is a 14-item, self-rated measure designed to be used as a brief screen for depression (7 items) and anxiety (7 items) disorders among nonpsychiatric, medically ill, outpatient populations (Zigmond & Snaith, 1983). As a screening instrument, the HADS does not provi... | [] |
NCT04712669 | 9.2.8.3 | Quick Inventory of Depressive Symptomatology | 9.2.8.3. Quick Inventory of Depressive Symptomatology The 16-item QIDS (Rush et al., 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in the clinician-rated (QIDS-C) and self-reported versions (QIDS-SR). Both versions assess all the criterion symptom domains designated by the Ameri... | [
"Altavant Sciences GmbH Effective: 19JAN2022"
] |
NCT04712669 | 9.3 | Adverse Events, Adverse Events of Special Interest, and Serious Adverse Events | 9.3. Adverse Events, Adverse Events of Special Interest, and Serious Adverse Events The definitions of an AE or SAE can be found in Appendix 14. AEs will be reported by the patient (or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The Investigator and any qualified d... | [] |
NCT04712669 | 9.3.1 | Adverse Events of Special Interest | 9.3.1. Adverse Events of Special Interest AESIs include: - Ь Severe constipation (and/or severe, persistent, or worsening abdominal pain) - Ь Depression/other significant mood-related disturbance (active suicidal ideation or behavior, severe depressive and/or anxious symptoms, other severe psychiatric TEAE) - Ь Elevati... | [] |
NCT04712669 | 9.3.2 | Time Period and Frequency for Collecting Adverse Event, Adverse Events of Special Interest, Serious Adverse Event Information | 9.3.2. Time Period and Frequency for Collecting Adverse Event, Adverse Events of Special Interest, Serious Adverse Event Information All SAEs will be collected from the signing of the ICF until the Follow-Up Visit at the time points specified in the SoA (Section 1.3). All AEs will be collected from the first dose of IP... | [] |
NCT04712669 | 9.3.3 | Method of Detecting Adverse Events, Adverse Events of Special Interest, and Serious Adverse Events | 9.3.3. Method of Detecting Adverse Events, Adverse Events of Special Interest, and Serious Adverse Events 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 14. Care will be taken not to introduce bias when... | [] |
NCT04712669 | 9.3.4 | Follow-up of Adverse Events, Adverse Events of Special Interest, and Serious Adverse Events | 9.3.4. Follow-up of Adverse Events, Adverse Events of Special Interest, and Serious Adverse Events After the initial AE/SAE report, the Investigator is required to proactively follow each patient at subsequent visits/contacts. All SAEs, and non-serious AESIs (as defined in Section 9.3.1), will be followed until resolut... | [] |
NCT04712669 | 9.3.5 | Regulatory Reporting Requirements for Serious Adverse Events | 9.3.5. Regulatory Reporting Requirements for Serious Adverse Events Prompt notification by the Investigator to the Sponsor of an SAE is essential so that legal obligations and ethical responsibilities towards the safety of patients and the safety of an IP under clinical investigation are met. The Sponsor has a legal re... | [] |
NCT04712669 | 9.3.6 | Pregnancy | 9.3.6. Pregnancy Patients will be instructed that if they/their partner become pregnant during the study, this should be reported to the Investigator. The Investigator should also be notified of any pregnancy that occurs during the study but not confirmed until after completion of the study for at least 5 terminal half... | [] |
NCT04712669 | 9.4 | Treatment of Overdose | 9.4. Treatment of Overdose Prior to this study, there has been no experience with rodatristat ethyl in patients with PAH. In healthy subjects, no safety concerns were identified following single doses ranging from 100 mg to 2000 mg or following repeat dosing over 14 days of up to 800 mg administered BID or up to 800 mg... | [] |
NCT04712669 | 9.5 | Pharmacokinetics | 9.5. Pharmacokinetics Blood samples for PK analysis of plasma rodatristat ethyl, rodatristat, M15 metabolite, selexipag, and ACT-333679 will be collected by indwelling cannula or venipuncture at the time points indicated in the SoA (Section 1.3). Note, selexipag/ACT-333679 PK samples will only be collected in subjects ... | [] |
NCT04712669 | 9.6 | Pharmacodynamics | 9.6. Pharmacodynamics Blood samples for determination of plasma 5-HIAA will be collected by indwelling cannula or venipuncture at the time points indicated in the SoA in Section 1.3. The actual date and time of each blood sample collection will be recorded. Urine samples will be collected for determination of 5-HIAA (b... | [] |
NCT04712669 | 10 | STATISTICAL CONSIDERATIONS | 10. STATISTICAL CONSIDERATIONS A detailed description of statistical methods will be provided in a separate Statistical Analysis Plan (SAP) and the SAP will be finalized prior to database lock. | [] |
NCT04712669 | 10.1 | Statistical Hypotheses | 10.1. Statistical Hypotheses No formal hypotheses are planned for the study. | [] |
NCT04712669 | 10.2 | Sample Size Determination | 10.2. Sample Size Determination The sample size for this study was not based on a formal hypothesis testing. It is expected that 30 patients per arm will provide sufficient data to assess the safety and efficacy. Power calculations were conducted to examine the probability of detecting a difference among treatment grou... | [] |
NCT04712669 | 10.3 | Populations for Analyses | 10.3. Populations for Analyses For purposes of analysis, the following populations are defined: | Population | Description | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT04712669 | 10.4 | Statistical Analyses | 10.4. Statistical Analyses The SAP will be developed and finalized before database lock and will describe the patient populations to be included in 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 secondar... | [] |
NCT04712669 | 10.4.1 | Efficacy Analyses | 10.4.1. Efficacy Analyses | Endpoint | Statistical Analysis Methods | |-----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT04712669 | 10.4.2 | Safety Analyses | 10.4.2. Safety Analyses Safety and tolerability will be evaluated by assessment of AE incidence and changes in clinical laboratory tests, physical examinations, vital signs measurements, ECG readings, and suicidal ideation and behavior ratings at various time points during the study. The following AE summaries will be ... | [] |
NCT04712669 | 10.4.3 | Other Analyses | 10.4.3. Other Analyses Patient reported outcomes (HADS and QIDS-C), PK, PD, and exploratory descriptive analyses will be described in the SAP finalized before database lock. Population PK and any PK/PD analyses will be documented in a separate analysis plan and may be reported separately. The planned analyses for the O... | [] |
NCT04712669 | 10.5 | Interim Analyses | 10.5. Interim Analyses An external, multidisciplinary, IDMC will review the progress of the study and perform interim reviews of unblinded safety data at regular intervals and provide recommendations to the Sponsor whether the nature, frequency, and severity of AEs and AESIs associated with IP warrant the early termina... | [] |
NCT04712669 | 10.5.1 | Independent Data Monitoring Committee | 10.5.1. Independent Data Monitoring Committee The primary role of the IDMC, which consists of independent physicians with experience in the care of patients with PAH and the conduct of randomized, controlled studies and one non-voting biostatistician, is to ensure the safety of the patients enrolled in the study, inclu... | [] |
NCT04712669 | 11 | REFERENCES | 11. REFERENCES - Abid, S., Houssaini, A., Chevarin, C., Marcos, E., Tissot, C.-M., Gary-Bobo, G., Wan, F., Mouraret, N., Amsellem, V., Dubois-Randé, J.-L., Hamon, M., & Adnot, S. (2012). Inhibition of gut- and lung-derived serotonin attenuates pulmonary hypertension in mice. American Journal of Physiology-Lung Cellular... | [
"APPENDIX 1. CONCOMITANT AND PROHIBITED MEDICATIONS",
"PROHIBITED MEDICATIONS",
"APPENDIX 2. DIARRHEA MANAGEMENT",
"APPENDIX 4. COLLECTION OF PREGNANCY INFORMATION",
"Definitions",
"Woman of childbearing potential",
"Women in the following categories are not considered women of childbearing potential",
... |
NCT04712669 | 11 | Outlook (Self): | 11. Outlook (Self): - 0 Sees self as equally worthwhile and deserving as others. - 1 Is more self-blaming than usual. - 2 Largely believes that he/she causes problems for others. - 3 Ruminates over major and minor defects in self. | [] |
NCT04712669 | 12 | Suicidal Ideation: | 12. Suicidal Ideation: - 0 Does not think of suicide or death. - 1 Feels life is empty or is not worth
living. - 2 Thinks of suicide/death several times a week for several minutes. - 3 Thinks of suicide/death several times a day in depth, or has made specific plans, or attempted suicide. | [
"living."
] |
NCT04712669 | 13 | Involvement: | 13. Involvement: - 0 No change from usual level of interest in other people and activities. - 1 Notices a reduction in former interests/activities. - 2 Finds only one or two former interests remain. - 3 Has virtually no interest in formerly pursued activities. | [] |
NCT04712669 | 14 | Energy/Fatiguability: | 14. Energy/Fatiguability: - 0 No change in usual level of energy. - 1 Tires more easily than usual. - 2 Makes significant personal effort to initiate or maintain usual daily activities. - 3 Unable to carry out most of usual daily activities due to lack of energy. | [] |
NCT04712669 | 15 | Psychomotor Slowing: | 15. Psychomotor Slowing: - 0 Normal speed of thinking, gesturing, and speaking. - 1 Patient notes slowed thinking, and voice modulation is reduced. - 2 Takes several seconds to respond to most questions; reports slowed thinking. - 3 Is largely unresponsive to most questions without strong encouragement. | [] |
NCT04712669 | 16 | Psychomotor Agitation: | 16. Psychomotor Agitation: - 0 No increased speed or disorganization in thinking or gesturing. - 1 Fidgets, wrings hands and shifts positions often. - 2 Describes impulse to move about and displays motor restlessness. - 3 Unable to stay seated. Paces about with or without permission. Altavant Sciences GmbH Effective: 1... | [
"APPENDIX 13. REVEAL LITE 2.0 (BENZA ET AL., 2020)",
"APPENDIX 14. ADVERSE EVENTS: DEFINITIONS AND PROCEDURES FOR RECORDING, EVALUATION, FOLLOW UP, AND REPORTING",
"Definition of Adverse Event",
"Adverse Event Definition",
"Events Meeting the Adverse Event Definition",
"Events NOT Meeting the Adverse Even... |
NCT04712669 | A | serious adverse event is defined as any untoward medical occurrence that, at any dose: | A serious adverse event is defined as any untoward medical occurrence that, at any dose:
1. Results in death
2. Is life-threatening The term 'life-threatening' in the definition of 'serious' refers to an event in which the patient was at risk of death at the time of the event. It does not refer to an event, which hyp... | [
"1. Results in death",
"2. Is life-threatening",
"3. Requires inpatient hospitalization or prolongation of existing hospitalization",
"4. Results in persistent disability/incapacity",
"5. Is a congenital anomaly/birth defect",
"6. Other situations:",
"Recording and Follow Up of Adverse Events and/or Ser... |
NCT04842240 | 1 | Key Trial Contacts | 1. Key Trial Contacts | Chief Investigator: | Mr Baek Kim, FRCS MD MA | | |---------------------|-----------------------------------------|--| | | Consultant Oncoplastic Breast Surgeon | | | | LeedsBreast and Reconstructive Unit | | | | St James's University Hospital | | | | Leeds, UK. | | | | 0113 2068724 | | | | b.ki... | [] |
NCT04842240 | 2 | Abbreviations | 2. Abbreviations | AE | Adverse Event | |----------|-----------------------------------------------------------------------------------------| | | | | ABS | Association of Breast Surgery | | BRCA | Breast Cancer Gene | | BREAST-Q | BREAST-Q questionnaire | | CI | Chief Investigator | | CNST | Clinical Negligence Scheme... | [] |
NCT04842240 | 3 | Background and Rationale | 3. Background and Rationale Breast cancer affects around 55000 women per year in the UK (2015-2017; Cancer Research UK) and 5 year survival for all breast cancer is favourable at 86.6% in the UK as a result of advances in locoregional and systemic treatment. Nationally approximately 40% of women undergo mastectomy to t... | [] |
NCT04842240 | 4 | Objectives and Outcome Measures | 4. Objectives and Outcome Measures Does the difference in the surgical technique for immediate implant breast reconstruction (pre- versus sub-pectoral) influence patient perceived outcomes?
Aims: The current lack of research evidence and guidelines on the topic signifies that the type of operation undertaken usually c... | [
"Aims:",
"Objectives:",
"Outcome Measures:"
] |
NCT04842240 | 5 | Trial Design | 5. Trial Design | [] |
NCT04842240 | 5.1 | Research Design | 5.1 Research Design A prospective non-randomised longitudinal cohort study with data collection for patients undergoing mastectomy with immediate implant based reconstruction surgery for early breast cancer or risk reduction using repeated measures and mixed methods. | [] |
NCT04842240 | 5.2 | Study Measures | 5.2 Study Measures - a) Clinical Outcomes and process of care measures - e.g. anaesthetic blocks used, number of hospital contacts, unplanned admissions, clinic appointments, phone calls with hospital staff, medications prescribed and taken, any changes to treatment plan. Details will be obtained via the individual ele... | [] |
NCT04842240 | 5.3 | Study Duration | 5.3 Study Duration Patients will be a participant in the study for approximately thirteen months. Thirteen months following surgery is completion of the patient's involvement in the study. | [] |
NCT04842240 | 5.4 | Findings | 5.4 Findings The overall findings will determine the feasibility of using this approach to support the care of patients undergoing immediate implant based reconstructive surgery for breast cancer or risk reduction. All data and opinions will inform the future development of information which aims to improve patient cho... | [] |
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