chufangao/CTO huggingface dataset:
Clinical trial NCT02964507: Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Participants With Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced or Metastatic Breast Cancer
Official title: A Phase I/II Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Combination With Fulvestrant in Subjects With Hormone Receptor-positive/HER2-negative (HR+/HER2-) Advanced or Metastatic Breast Cancer
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: This study has been terminated due to meeting protocol defined futility.
Enrollment: 124.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-09-26
Primary completion date: 2020-09-29
Completion date: 2021-07-19
Baseline population: The interim analysis failed to demonstrate clinically meaningful activity, hence Phase II was not initiated.
Plan to share individual participant data: YES
IPD sharing description: GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
IPD time frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Clinical trial NCT02257567: A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma
Official title: A Phase IB/II Study Evaluating The Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin in Combination With Rituximab (R) or Obinutuzumab (G) Plus Bendamustine (B) in Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 331.0 (ACTUAL)
Number of arms: 12.0
Start date: 2014-10-15
Primary completion date: 2021-10-21
Completion date: 2021-10-21
Baseline population: Intent-to-treat (ITT) population included all participants who were randomized, whether or not the participants received the assigned treatment.
Clinical trial NCT03303469: Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging
Official title: Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: [18F]Fluoromisonidazole (FMISO) Imaging
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: study was terminated due to poor enrollment
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-10-30
Primary completion date: 2021-01-06
Completion date: 2021-01-06
Clinical trial NCT03846102: MORphine Use in the Fascia Iliaca Compartment Block With UltraSound
Official title: MORphine Use in the Fascia Iliaca Compartment Block With UltraSound
Acronym: MORFICUS
Sponsor: Zuyderland Medisch Centrum (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: COVID-19 crisis.
Enrollment: 55.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-28
Primary completion date: 2020-02-18
Completion date: 2020-02-18
Plan to share individual participant data: NO
Clinical trial NCT05711862: The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder
Official title: The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder
Sponsor: The University of Texas Health Science Center, Houston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of enrollment
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-03-09
Primary completion date: 2024-03-28
Completion date: 2024-03-28
Plan to share individual participant data: NO
Clinical trial NCT04859582: Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)-China Extension
Official title: A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Withdrawn due to protocol amendment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-08
Primary completion date: 2024-11-29
Completion date: 2024-11-29
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT03973879: Combination of PVSRIPO and Atezolizumab for Adults With Recurrent Malignant Glioma
Official title: A Phase 1b/2 Trial of PVSRIPO in Combination With Atezolizumab in Recurrent WHO Grade IV Malignant Glioma
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Re-submission Planned
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-29
Primary completion date: 2024-01-31
Completion date: 2024-01-31
Plan to share individual participant data: NO
Clinical trial NCT05209308: Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL
Official title: A Phase 2 Single-Arm, Open-Label Study to Assess the Safety and Efficacy of Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia - The CORAL Study
Acronym: CORAL
Sponsor: MEI Pharma, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Discontinuation of zandelisib development
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-11-22
Primary completion date: 2023-03-15
Completion date: 2023-03-15
Clinical trial NCT05249829: A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19
Official title: A Phase 2/3, Randomized, Observer-blind, Active-controlled, Multicenter Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 (Prototype) Booster Vaccine
Sponsor: ModernaTX, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 3548.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-02-16
Primary completion date: 2023-06-23
Completion date: 2023-06-23
Baseline population: The Safety Set included all randomized participants who received the study vaccine. Participants were included in the study vaccine arm that they actually received.
Plan to share individual participant data: NO
Clinical trial NCT05206656: Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer
Official title: Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer Patients: An Open-Labeled, Single-center, Prospective Study
Sponsor: Hunan Cancer Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-09
Primary completion date: 2022-04-30
Completion date: 2022-07-20
Plan to share individual participant data: NO
Clinical trial NCT03515551: Safety and Efficacy of IMCnyeso in Advanced NY-ESO-1 and/or LAGE-1A Positive Cancers
Official title: A Phase I/II Study of IMCnyeso, HLA- A*0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, in HLA-A*0201 Positive Patients With Advanced NY-ESO-1 and/or LAGE - 1A Positive Cancer
Sponsor: Immunocore Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Strategic decision to stop development and not based on any safety concerns
Enrollment: 29.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-15
Primary completion date: 2021-05-10
Completion date: 2021-05-10
Baseline population: The Full Analysis Set includes all participants assigned to treatment who receive at least 1 full or partial dose of study drug; one participant that sequentially enrolled in two cohorts (10 mcg and 30-100 mcg) is represented in the 30-100 mcg cohort.
Plan to share individual participant data: NO
Clinical trial NCT04143165: Ultrasound Guided Epidural Block in Axial SPA
Official title: Ultrasound Guided Epidural Block in Axial SPA Patient With Limited Spine Mobility: a Prospective Pilot Randomized Controlled Trial
Sponsor: Sohag University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 52.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-12
Primary completion date: 2020-01-12
Completion date: 2020-02-12
Plan to share individual participant data: NO
IPD sharing description: The consent form does not include this item
Clinical trial NCT03240523: Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
Official title: A Randomized, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
Acronym: ASTEROID 5
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to a change in the development program, the study was closed prematurely.
Enrollment: 766.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-07-31
Primary completion date: 2020-06-28
Completion date: 2021-10-25
Plan to share individual participant data: NO
IPD sharing description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Clinical trial NCT03773172: Study to Evaluate the Effects of MEDI6012 on Apolipoprotein B100 Metabolism
Official title: Study to Evaluate the Effects of Two Doses Over 48 Hours of MEDI6012 on Apolipoprotein B100 Metabolism in Subjects With Stable Atherosclerotic Cardiovascular Disease
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Early termination due to COVID-19
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-31
Primary completion date: 2020-05-20
Completion date: 2020-05-20
Plan to share individual participant data: NO
Clinical trial NCT04419389: APR-246 in Combination With Acalabrutinib or Venetoclax Based Therapy in Subjects With R/R Non Hodgkin Lymphomas (NHL)
Official title: Phase 1 and Dose Expansion Study of APR-246 in Combination With Acalabrutinib or Venetoclax-based Therapy in Subjects With R/R NHL Including Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL)
Acronym: R/R
Sponsor: Aprea Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 1.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-03-02
Primary completion date: 2021-08-23
Completion date: 2021-08-24
Plan to share individual participant data: NO
Clinical trial NCT04117958: Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers
Official title: A Global Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of the Half-life Extended Bispecific T-cell Engager AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business decision
Enrollment: 58.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-20
Primary completion date: 2023-06-01
Completion date: 2023-06-01
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT04536922: Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated or Viral Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab
Official title: Single Patient Protocol: A Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated or Viral Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Subject no longer able to participate in this single pt study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-27
Primary completion date: 2021-01-27
Completion date: 2021-01-27
Clinical trial NCT02362230: Evaluation of Icotinib in Metastatic Triple-negative Breast Cancer After Second-line Therapy
Official title: Sun Yat-sen University Cancer Center
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Difficulty accruing subjects the study accrual was closed
Enrollment: 26.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-01-31
Primary completion date: 2020-12-15
Completion date: 2020-12-15
Plan to share individual participant data: NO
Clinical trial NCT03056638: Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer
Official title: Phase III Randomized Trial Comparing Short Course Androgen Deprivation Therapy and Ultra-Hypofractionated SBRT Versus SBRT Alone For Intermediate Prostate Cancer
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to low accrual
Enrollment: 56.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-03-28
Primary completion date: 2023-08-16
Completion date: 2023-08-16
Clinical trial NCT03412734: Vaginal Preparation Prior to Hysterectomy
Official title: Is Chlorhexidine Vaginal Preparation Prior to Hysterectomy Superior to Iodine in Reducing Bacterial Count; a Randomized Controlled Trial
Sponsor: TriHealth Inc. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The institutional review board recommended the study stop enrollment prior to achieving its initial sample size for patient safety.
Enrollment: 94.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-18
Primary completion date: 2019-08-26
Completion date: 2020-01-29
Plan to share individual participant data: NO
Clinical trial NCT05172349: Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Trophic Ulcers
Official title: Pilote Study of the Use of a Double Amniotic Membrane Inserted in a Ring of Umbilical Vessels With Wharton's Jelly, Tissues Treated by the AMTRIX Process, in the Treatment of Trophic Ulcers
Sponsor: TBF Genie Tissulaire (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Change in sponsor's strategy
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-04-30
Primary completion date: 2022-09-30
Completion date: 2022-09-30
Clinical trial NCT03818399: Virginia Opioid Overdose Treatment InitiatVE
Official title: Virginia Opioid Overdose Treatment InitiatVE
Acronym: VOTIVE
Sponsor: Virginia Commonwealth University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to a financial business decision by the company supporting the research study (Indivior). The decision was not due to adverse events, safety reasons, or scientific reasons, but was a business decision.
Enrollment: 19.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-04
Primary completion date: 2021-02-24
Completion date: 2021-02-24
Clinical trial NCT04909892: Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 Long Haul Pulmonary Compromise
Official title: A Phase 2a Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 Long Haul Pulmonary Compromise
Sponsor: Sorrento Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Replaced by a different protocol.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-31
Primary completion date: 2022-01-31
Completion date: 2022-01-31
Clinical trial NCT04333420: Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
Official title: A Pragmatic Adaptive Randomized, Controlled Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
Acronym: PANAMO
Sponsor: InflaRx GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 399.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-03-31
Primary completion date: 2021-10-31
Completion date: 2021-12-01
Baseline population: Full Analysis Set (excluding one subject who was randomized in error to group Phase III: IFX-1 + SOC)
Plan to share individual participant data: NO
Clinical trial NCT03596073: Topical Calcipotriene Treatment for Breast Cancer Immunoprevention
Official title: A Pilot Trial of Topical Calcipotriene Treatment for Breast Cancer Immunoprevention
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Interim analysis did not show the required cytokine induction by topical calcipotriene to justify continuation of the trial
Enrollment: 43.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-07
Primary completion date: 2020-08-31
Completion date: 2020-08-31
Plan to share individual participant data: NO
Clinical trial NCT04143958: To Assess the Glycosphingolipid Clearance and Clinical Effects of Switching to Agalsidase Beta (Fabrazyme) Versus Continuing on Agalsidase Alfa (Replagal) in Male Patients With Classic Fabry Disease
Official title: A Randomized, Open-label, Active Comparator, 2-arm, Prospective Study to Assess the Glycosphingolipid Clearance and Clinical Effects of Switching to Agalsidase Beta (Fabrazyme) Versus Continuing on Agalsidase Alfa (Replagal) in Male Patients With Classic Fabry Disease
Acronym: BCLEAR1
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: The Sponsor terminated the study due to recruitment infeasibility without having enrolled any patient.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-30
Primary completion date: 2023-11-30
Completion date: 2023-11-30
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT04591028: A Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients
Official title: Indocyanine Green Lymphangiography as a Tool for Improving Lymphadenectomy in Gastric Cancer
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Lack of funding.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-01-31
Primary completion date: 2022-01-31
Completion date: 2022-08-10
Plan to share individual participant data: NO
Clinical trial NCT03813238: A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
Acronym: RECLAIM-DCP
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 63.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-06
Primary completion date: 2022-07-05
Completion date: 2022-07-21
Baseline population: The intent-to-treat (ITT) analysis set included all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.