chufangao/CTO huggingface dataset:
Clinical trial NCT04680975: Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis
Official title: A Phase 2, Open-label Multicenter Study to Evaluate the Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Acronym: dcSSC
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision due to slow enrollment and strategic consideration; not driven by any safety concerns.
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-03
Primary completion date: 2022-05-10
Completion date: 2022-12-19
Baseline population: Analysis was performed on modified intent to treat (mITT) population which included all participants who received at least 1 dose of belumosudil 200 mg.
Limitations and caveats: Due to slow enrollment and strategic consideration, Sponsor decided to terminate the study and the termination was not driven by any safety concerns.
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 NCT04836832: Acalabrutinib and Duvelisib for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
Official title: A Phase Ib/II Study of Duvelisib and Acalabrutinib in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (DUAL Trial)
Sponsor: Ohio State University Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: PI decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-07-01
Primary completion date: 2023-12-31
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT05438758: Repeated Intranasal Esketamine Plus Almond Therapy in Participants With Treatment Resistant Depressive Disorder - 3 Month Extension Study
Official title: Phase 2, Controlled, Single-Blind, 3-Month Extension Study For Participants Originally Diagnosed With Treatment Resistant Major Depressive Disorder (TRD) Who Complete Study ZYL-730-01 With, or Without, Almond Therapy
Acronym: ZYL-730-02
Sponsor: Zylorion Health (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Withdrawn by Sponsor
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-01-15
Primary completion date: 2024-02-01
Completion date: 2024-03-01
Plan to share individual participant data: YES
IPD sharing description: IPD will be available to other members of the study team including Dr. Craig Buchholz
IPD time frame: Throughout the study
IPD access criteria: Involved in data collection
Clinical trial NCT04234516: Anti-suicidal Effects of Buprenorphine in Opioid Use Disorder
Official title: Functional Brain Mechanisms Underlying the Anti-suicidal Effects of Buprenorphine in Opioid Use Disorder
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: PI leaving the institute
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-20
Primary completion date: 2021-06-10
Completion date: 2021-06-10
Plan to share individual participant data: NO
Clinical trial NCT03910439: Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma
Official title: A Phase II Pilot Study of Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow/Insufficient accrual/COVID-19 pandemic
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-17
Primary completion date: 2020-11-04
Completion date: 2020-11-04
Plan to share individual participant data: NO
Clinical trial NCT02198209: Liraglutide Actions on the Liver: Effects on Glucose Phosphorylation
Official title: Liraglutide Actions on the Liver: Effects on Glucose Phosphorylation
Sponsor: Cedars-Sinai Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Investigator decided not to move forward with study prior to study start date
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-12-31
Primary completion date: 2020-07-31
Completion date: 2020-12-31
Clinical trial NCT04206605: A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)
Official title: A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 77.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-04
Primary completion date: 2022-10-20
Completion date: 2022-10-20
Baseline population: Safety analysis set (SAS) included all participants who received any exposure to the investigational product.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT04713202: Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl
Official title: Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl (NET-PACS Trial) Big Ten Cancer Research Consortium BTCRC-GI19-400
Acronym: NET-PACS
Sponsor: Big Ten Cancer Research Consortium (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Funder decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-03
Primary completion date: 2023-02-28
Completion date: 2024-02-29
Clinical trial NCT04622072: XZP-5809-TT1 Tablets in Patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
Official title: A Single-arm, Open, Multi-center Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Effectiveness of XZP-5809-TT1 Tablets in Patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Have Progressed After Treatment With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI).
Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic considerations
Enrollment: 21.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-02
Primary completion date: 2021-05-20
Completion date: 2022-04-27
Plan to share individual participant data: NO
Clinical trial NCT04072887: Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients
Official title: A 24-week Multi-center, Double-blind, Placebo Controlled Dose-range Finding Study to Investigate the Efficacy and Safety of Oral QBW251 in COPD Patients on Triple Inhaled Therapy (LABA / LAMA / ICS)
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 974.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-09-12
Primary completion date: 2021-10-08
Completion date: 2022-02-01
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT04408040: Use of Convalescent Plasma for COVID-19
Official title: Use of Convalescent Plasma Collected From Donors Recovered From COVID-19 Virus Disease for Transfusion, as an Empirical and Preemptive Treatment During Viral Pandemic Outbreak
Sponsor: Northside Hospital, Inc. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: New information regarding use of plasma in covid + patients
Enrollment: 8.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-07-14
Primary completion date: 2021-09-14
Completion date: 2021-09-14
Baseline population: No critical patients were consented for this study
Clinical trial NCT04240158: IW-6463 Safety Study in Healthy Elderly Subjects
Official title: Evaluating the Safety, Tolerability, and Pharmacodynamic Properties of IW-6463 in Healthy Elderly Subjects
Sponsor: Tisento Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Some subjects could not complete the second crossover period due to COVID-19-related site closure. The study was closed to allow analysis of all collected data.
Enrollment: 24.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-06
Primary completion date: 2020-05-22
Completion date: 2020-05-22
Plan to share individual participant data: NO
Clinical trial NCT04702997: A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN)
Official title: A Phase 2 Trial to Evaluate Safety, Tolerability, and Efficacy of Bardoxolone Methyl in Patients With Chronic Kidney Disease at Risk of Rapid Progression
Acronym: MERLIN
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 81.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-09
Primary completion date: 2021-10-20
Completion date: 2021-11-23
Plan to share individual participant data: YES
IPD sharing description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Clinical trial NCT03749109: Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis
Official title: A Randomised, Double-blind, Placebo-controlled, Proof-of-mechanism Phase 2 Trial Investigating the Effect of Quinagolide Extended-release Vaginal Ring on Reduction of Lesions Assessed by High-resolution Magnetic Resonance Imaging in Women With Endometrioma, Deep Infiltrating Endometriosis, and/or Adenomyosis
Acronym: QLARITY
Sponsor: Ferring Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 67.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-19
Primary completion date: 2021-06-21
Completion date: 2021-07-18
Plan to share individual participant data: NO
Clinical trial NCT04341441: Will Hydroxychloroquine Impede or Prevent COVID-19
Official title: Will Hydroxychloroquine Impede or Prevent COVID-19: WHIP COVID-19 Study
Acronym: WHIP COVID-19
Sponsor: Henry Ford Health System (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Interim analysis did not reveal any safety concerns by the DSMB, but unblinded data did not provide support to continue. Event rate did not meet projected magnitude; given low recruitment potential, it is unlikely that a positive result will occur.
Enrollment: 624.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-04-07
Primary completion date: 2020-12-15
Completion date: 2020-12-15
Limitations and caveats: Study has been terminated. Interim analysis did not reveal any safety concerns by the DSMB with hydroxychloroquine treatment, but unblinded data did not provide support to continue due to low numbers of events. Event rate did not meet projected magnitude; given low recruitment potential, it is unlikely that a positive result will occur.
Plan to share individual participant data: NO
Clinical trial NCT03770091: Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis
Official title: Impact of Theraworx Foam on Pain and Motion and Patient-Reported Outcomes in Thumb Arthritis
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-12-21
Primary completion date: 2020-07-30
Completion date: 2020-08-01
Plan to share individual participant data: NO
Clinical trial NCT01583842: 124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study
Official title: 124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Funding
Enrollment: 10.0 (ACTUAL)
Number of arms: 3.0
Start date: 2013-04-09
Primary completion date: 2021-02-25
Completion date: 2021-02-25
Plan to share individual participant data: NO
Clinical trial NCT03419130: Radiation Therapy and Pembrolizumab in Treating Patients With Localized Urothelial Bladder Cancer
Official title: A Phase II Study of Radiation Therapy and Pembrolizumab in Patients With Localized Urothelial Bladder Cancer That Are Ineligible or Refusing Chemotherapy
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study withdrawn prior to patient enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-18
Primary completion date: 2020-12-31
Completion date: 2022-12-31
Clinical trial NCT04605926: A Study to Evaluate the Efficacy and Safety of Itolizumab in Subjects Hospitalized With COVID-19
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Itolizumab in Subjects Hospitalized With COVID-19
Acronym: EQUINOX
Sponsor: Equillium (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Sponsor has currently elected to withhold study initiation
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-30
Primary completion date: 2021-04-30
Completion date: 2021-06-30
Plan to share individual participant data: NO
Clinical trial NCT03417882: GRN-1201 With Pembrolizumab in Subjects With Metastatic PD-L1+ NSCLC
Official title: A Pilot, Open-Label, Multi-Center, Multi-Dose Study of GRN-1201 Added to Pembrolizumab in Subjects With Non-Small Cell Lung Cancer With High PD-L1 Expression
Sponsor: BrightPath Biotherapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Recruitment rate too slow
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-03
Primary completion date: 2022-12-05
Completion date: 2022-12-05
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04360876: Targeted Steroids for ARDS Due to COVID-19 Pneumonia: A Pilot Randomized Clinical Trial
Official title: Targeted Steroids for ARDS Due to COVID-19 Pneumonia: A Pilot Randomized Clinical Trial
Sponsor: University of Colorado, Denver (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Funding not received
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-01
Primary completion date: 2020-12-31
Completion date: 2021-01-30
Plan to share individual participant data: NO
IPD sharing description: No Plan
Clinical trial NCT04248465: An Efficacy and Safety Study of Ravulizumab in ALS Participants
Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS)
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The IDMC recommended the study be discontinued due to lack of efficacy with ravulizumab.
Enrollment: 382.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-30
Primary completion date: 2021-10-17
Completion date: 2021-10-17
Baseline population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug grouped by randomized treatment group.
Limitations and caveats: The IDMC recommended the study be discontinued due to lack of efficacy with ravulizumab.
Clinical trial NCT04260607: Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department
Official title: Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department
Sponsor: Naval Medical Center Camp Lejeune (FED)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: As a busy MTF we were unable to retain a health care provider with the appropriate expertise to buy-in to this study once the initiating PI left military service.
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-14
Primary completion date: 2021-04-24
Completion date: 2022-02-16
Plan to share individual participant data: NO
Clinical trial NCT04375514: Study of ARO-ENaC in Healthy Volunteers and in Patients With Cystic Fibrosis
Official title: A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetic Effects of ARO-ENaC in Normal Healthy Volunteers and Safety, Tolerability and Efficacy in Patients With Cystic Fibrosis
Sponsor: Arrowhead Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business decision
Enrollment: 43.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-10
Primary completion date: 2021-09-03
Completion date: 2021-09-03
Plan to share individual participant data: NO
Clinical trial NCT04672876: Telotristat Ethyl for Reducing Intraoperative Carcinoid Crisis in Patients With Neuroendocrine Tumors
Official title: Telotristat Ethyl for Reducing the Incidence of Intraoperative Carcinoid Crisis in Patients With Small Bowel Neuroendocrine Tumors
Sponsor: University of Chicago (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Trial funding no longer available.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-01-31
Primary completion date: 2022-10-01
Completion date: 2023-10-01
Clinical trial NCT02203773: Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)
Official title: A Phase 1b Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine in Treatment-Naive Subjects With Acute Myelogenous Leukemia Who Are Greater Than or Equal to 60 Years of Age and Who Are Not Eligible for Standard Induction Therapy
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic considerations
Enrollment: 212.0 (ACTUAL)
Number of arms: 3.0
Start date: 2014-10-06
Primary completion date: 2022-06-16
Completion date: 2022-06-16
Plan to share individual participant data: NO
Clinical trial NCT05041972: ARX788 in Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors (ACE-Pan Tumor-02)
Official title: A Global Phase 2 Study to Evaluate the Efficacy and Safety of ARX788 for Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors
Sponsor: Ambrx, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Business strategy change
Enrollment: 0.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-11-05
Primary completion date: 2022-04-20
Completion date: 2022-04-20
Plan to share individual participant data: NO
IPD sharing description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available after the studies for which the medicine and indication have received marketing approval in European Union (EU) and United States (US) or regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Clinical trial NCT06097273: A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
Official title: A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
Sponsor: ModernaTX, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 8075.0 (ACTUAL)
Number of arms: 4.0
Start date: 2023-10-19
Primary completion date: 2024-05-28
Completion date: 2024-05-28
Clinical trial NCT03540225: Vaginal Progesterone for the Prevention of Preterm Birth in Twins
Official title: Vaginal Progesterone for the Prevention of Preterm Birth in Twins: A Pilot Randomised, Factorial Designed Trial (POPPET)
Acronym: POPPET
Sponsor: Chinese University of Hong Kong (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Fail to sort out the logistics of study drugs due to funding problems
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-04-30
Primary completion date: 2022-04-30
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT03985293: A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus
Official title: A 16-WEEK, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TWICE DAILY PF-06882961 ADMINISTRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED ON METFORMIN OR DIET AND EXERCISE
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 412.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-10-15
Primary completion date: 2021-06-08
Completion date: 2021-07-07
Baseline population: A total of 412 participants were assigned to treatment, 411 of whom were treated; 1 participant randomized to the PF-06882961 120 mg BID group was not treated.
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT03905538: Evaluation of [18F]FLT PET/CT as an Early Predictor of Outcome in Pediatric Solid Tumors
Official title: Evaluation of [18F]FLT PET/CT as an Early Predictor of Outcome in Pediatric Solid Tumors
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Lack of accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-08-13
Primary completion date: 2024-12-31
Completion date: 2024-12-31