chufangao/CTO huggingface dataset:
Clinical trial NCT03996486: Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia
Official title: A Multicenter, Non-randomized, Open-label, Multiple Dose Escalation Study to Evaluate the Safety and Tolerability of Subcutaneous BAY1093884 in Males With Severe Hemophilia
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Company decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-28
Primary completion date: 2020-05-29
Completion date: 2020-07-31
Plan to share individual participant data: UNDECIDED
IPD sharing description: Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Clinical trial NCT04685421: Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery
Official title: Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery
Acronym: CohortI-II
Sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: PI, Christopher Tirotta, no longer at NCH as of 5-26-23.
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-15
Primary completion date: 2023-06-01
Completion date: 2023-06-01
Plan to share individual participant data: YES
IPD sharing description: De-identified will be posted in website.
IPD time frame: one year after study closure
IPD access criteria: Information will be provided by request to the PI
Clinical trial NCT04762511: A Study on the Reactogenicity, Safety and Immune Response of a Vaccine Against Herpes Simplex Virus (HSV)-2 in Healthy Participants Aged 18-40 Years
Official title: A Phase I, Single-blind, Randomised, Placebo-controlled, Dose Escalation Study to Evaluate the Reactogenicity, Safety and Immune Response of an HSV Vaccine in Healthy Participants Aged 18-40 Years
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: To enable development of an enhanced version of the vaccine
Enrollment: 17.0 (ACTUAL)
Number of arms: 8.0
Start date: 2021-03-02
Primary completion date: 2021-05-26
Completion date: 2021-05-26
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
Clinical trial NCT03600909: A Study of the Effect of Blood Stem Cell Transplant After Chemotherapy Alone in Patients With Fanconi Anemia
Official title: A Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Risk-Adjusted Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Accrual has been slow
Enrollment: 3.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-05-15
Primary completion date: 2021-04-09
Completion date: 2021-04-09
Baseline population: Study closed due to slow accrual
Clinical trial NCT04371978: Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19
Official title: Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19
Sponsor: Rabin Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: End of COVID-19 outbreak in Israel
Enrollment: 64.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-01
Primary completion date: 2021-04-04
Completion date: 2021-05-04
Plan to share individual participant data: NO
Clinical trial NCT04588259: Research Study to Compare a New Medicine Fast-acting Insulin Aspart to Another Medicine Insulin Aspart in Chinese People With Diabetes
Official title: Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec With or Without Metformin in Adults With Diabetes
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 331.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-09
Primary completion date: 2022-07-05
Completion date: 2022-08-05
Baseline population: Full analysis set (FAS) which included all randomised participants.
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT04299373: Surgical Weight Loss and Alcohol Perception
Official title: Effects of Metabolic Surgery on Alcohol Pharmacokinetics
Acronym: SWAP
Sponsor: University of Missouri-Columbia (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: In an effort to seek a more suitable method to measure alcohol clearance.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-10
Primary completion date: 2022-09-09
Completion date: 2022-09-09
Plan to share individual participant data: NO
Clinical trial NCT04649151: A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19
Official title: A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Adolescents 12 to <18 Years of Age
Acronym: TeenCove
Sponsor: ModernaTX, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 4331.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-12-09
Primary completion date: 2024-06-14
Completion date: 2024-06-14
Clinical trial NCT04487210: A Study to Evaluate the Safety and Immunogenicity of MVC-COV1901 Against COVID-19
Official title: A Phase I, Prospective, Open-Labeled Study to Evaluate the Safety and Immunogenicity of MVC-COV1901
Sponsor: Medigen Vaccine Biologics Corp. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-10-07
Primary completion date: 2021-06-01
Completion date: 2021-12-06
Clinical trial NCT06036511: Connectivity Changes Associated With Ketamine Assisted Psychotherapy for PTSD
Official title: Connectivity Changes Associated With Ketamine Assisted Psychotherapy for PTSD
Acronym: CONCHKAP
Sponsor: University of New Mexico (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Per PI, this trial will not be started at UNM due to change in institutional responsibilities of the PI
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-12-31
Primary completion date: 2023-12-31
Completion date: 2023-12-31
Plan to share individual participant data: NO
Clinical trial NCT04359095: Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia
Official title: Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia: A Pragmatic Randomized Controlled Trial
Sponsor: Universidad Nacional de Colombia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 650.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-08-18
Primary completion date: 2021-03-20
Completion date: 2021-06-30
Plan to share individual participant data: YES
IPD sharing description: Communicating trial results and data to be able to combine data from multiple studies (live SR)
IPD time frame: As soon we have checked the quality of data of recruited participants
IPD access criteria: Approved by the monitor committee of the study
Clinical trial NCT05167526: A Study to Find a Suitable Dose of ASP8731 and Check for Medical Problems at Each Dose in Healthy Adults
Official title: A Phase 1 Combined Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP8731 in Healthy Adult Participants, Including an Assessment of a Food Effect
Sponsor: Astellas Pharma Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated due to protocol defined stopping criteria being met.
Enrollment: 36.0 (ACTUAL)
Number of arms: 6.0
Start date: 2022-03-07
Primary completion date: 2022-11-10
Completion date: 2022-11-10
Plan to share individual participant data: NO
IPD sharing description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.
Clinical trial NCT03954639: Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Analgesia in Lower Extremity Surgeries
Official title: A Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupivacaine vs. Bupivacaine Only Administered as Combined Sciatic (in Popliteal Fossa) and Adductor Canal Nerve Block for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
Acronym: STRIDE
Sponsor: Pacira Pharmaceuticals, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Sponsor Decision.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-06-15
Primary completion date: 2020-09-30
Completion date: 2020-09-30
Plan to share individual participant data: NO
Clinical trial NCT04634409: A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness
Official title: A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Mono and Combination Therapy With Monoclonal Antibodies in Participants With Mild to Moderate COVID-19 Illness (BLAZE-4)
Acronym: BLAZE-4
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 1755.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-10-29
Primary completion date: 2021-07-27
Completion date: 2021-10-18
Baseline population: All participants who received at least one dose of study drug.
Plan to share individual participant data: YES
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Clinical trial NCT03519256: A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder
Official title: A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer
Acronym: CheckMate 9UT
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Insufficient Enrollment
Enrollment: 142.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-08-02
Primary completion date: 2022-08-22
Completion date: 2022-08-24
Limitations and caveats: As of early April 2021, Study CA2099UT enrollment was significantly behind the projected target enrollment, (number of participants enrolled 142; target enrollment 480). Since the study would be unable to meet the scientific objectives within a projected timeline, a decision was made in May 2021 to close the study.
Clinical trial NCT04352413: A Study of PLM60 in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy
Official title: An Open-label, Multi-center, Phase 2 Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection (PLM60) in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The sponsor has adjusted its R\&D strategy.
Enrollment: 45.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-18
Primary completion date: 2022-01-30
Completion date: 2022-04-29
Plan to share individual participant data: NO
Clinical trial NCT02405910: Ph2 Nab-paclitaxel With Gemcitabine to Determine Efficacy in Advanced Non-squamous NSCLC.
Official title: A Phase II Randomized Study of Nab-paclitaxel With Gemcitabine at Two Different Dose Combinations to Determine Efficacy in Patients With Advanced Non- Squamous Non-small Cell Lung Cancer (NSCLC).
Sponsor: West Virginia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: PI Left Institution
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-03-15
Primary completion date: 2017-12-31
Completion date: 2023-04-30
Clinical trial NCT04383756: Utilization of Donor Whole Blood for Blood Transfusion in Deceased Donor Liver Transplantation
Official title: Utilization of Donor Whole Blood for Blood Transfusion in Deceased Donor Liver Transplantation
Sponsor: Vanderbilt University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Study was never started
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-31
Primary completion date: 2021-07-31
Completion date: 2021-07-31
Plan to share individual participant data: NO
Clinical trial NCT03035838: Importance of Substance P in Intracranial Pressure Elevation Following Traumatic Brain Injury
Official title: Importance of Substance P in Intracranial Pressure Elevation Following Traumatic Brain Injury
Acronym: NK1
Sponsor: University of Cambridge (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Alternate study commenced using different drug
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-11-30
Primary completion date: 2022-12-31
Completion date: 2023-04-30
Plan to share individual participant data: NO
Clinical trial NCT02448771: A Study of Palbociclib in Combination With Bazedoxifene in Hormone Receptor Positive Breast Cancer
Official title: A Phase Ib/II Study of Palbociclib in Combination With Bazedoxifene in Hormone Receptor Positive Breast Cancer
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-07-09
Primary completion date: 2019-08-12
Completion date: 2021-03-03
Clinical trial NCT03796507: Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation
Official title: Early Post-surgical Temozolomide Therapy in Patients With High-Grade Gliomas Admitted to Acute Rehabilitation: A Feasibility Study
Sponsor: University of Rochester (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Hiring freeze of research personnel due to COVID pandemic
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-01
Primary completion date: 2021-12-15
Completion date: 2021-12-15
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02524379: Spinal Cord Injury Neuroprotection With Glyburide
Official title: Spinal Cord Injury Neuroprotection With Glyburide; Pilot Study: An Open-Label Prospective Evaluation of the Feasibility, Safety, Pharmacokinetics, and Preliminary Efficacy of Oral Glyburide (DiaBeta) in Patients With Acute Traumatic Spinal Cord Injury
Acronym: SCING
Sponsor: Ohio State University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Principal investigator has left the university; there were not enough participants to analyze the data.
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-02-14
Primary completion date: 2021-02-08
Completion date: 2021-02-08
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05116228: Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis in Low Disease Activity and Remission
Official title: Randomized, Prospective, Active-comparator Controlled, Patient-blinded Study to Demonstrate Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis Patients in Low Disease Activity and Remission - the REDOREM Study
Acronym: REDOREM
Sponsor: Medical University of Vienna (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Failure to recruit
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-09-01
Primary completion date: 2021-11-01
Completion date: 2021-11-01
Plan to share individual participant data: NO
Clinical trial NCT04017013: Therapeutic Efficacy of Intravenous Lidocaine Infusion Compared With Epidural Analgesia for Postoperative Pain Control in Adult Patients Undergoing Major Abdominal Surgery: Non-Inferiority Clinical Trial
Official title: Therapeutic Efficacy of Intravenous Lidocaine Infusion Compared With Epidural Analgesia for Postoperative Pain Control in Adult Patients Undergoing Major Abdominal Surgery: Non-Inferiority Clinical Trial
Sponsor: Universidad de Antioquia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 210.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-01
Primary completion date: 2022-09-05
Completion date: 2022-09-05
Plan to share individual participant data: NO
Clinical trial NCT04414241: Hydroxychloroquine to Prevent SARS-CoV-2 Infection/COVID-19
Official title: Hydroxychloroquine to Prevent SARS-CoV-2 Infection Among Healthcare Workers: Randomized Controlled, Open-label, Phase 3 Clinical Trial
Sponsor: Universidad Peruana Cayetano Heredia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 68.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-25
Primary completion date: 2020-11-23
Completion date: 2020-11-23
Plan to share individual participant data: NO
Clinical trial NCT03305666: Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures
Official title: A Randomized Clinical Trial of Single Dose Liposomal Bupivacaine Delivered Via VATS Intercostal Nerve Block vs. Continuous Bupivacaine Infusion Delivered Via Indwelling Subscapular Catheter After Surgical Stabilization of Rib Fractures
Sponsor: Denver Health and Hospital Authority (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-05
Primary completion date: 2020-07-20
Completion date: 2021-01-31
Baseline population: The baseline analysis did not include two patients who were withdrawn from the study.
Limitations and caveats: There were no limitations that created barriers to the completion of this project. While this was expected at the outset of this exploratory trial, there was a relatively small sample size with a wide range of fractures for individual participants. Underpowering likely limited analyses of secondary outcomes such as narcotic requirements and failure of LRA. The study also excluded patients with GCS \< 8, so caution should be exercised when extrapolating to mechanically ventilated patients.
Plan to share individual participant data: NO
Clinical trial NCT04874714: Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis
Official title: Prospective, Randomized, Placebo-controlled, Multi-center Trial Comparing the Efficacy and Safety of Subcutaneous Immunotherapy With a Mixture of Grasses and Mites at Adequate Doses Versus Monotherapy, for the Treatment of Allergy
Sponsor: Inmunotek S.L. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to the low recruitment rate since the start of the trial
Enrollment: 18.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-04-30
Primary completion date: 2023-10-09
Completion date: 2023-10-09
Plan to share individual participant data: NO
Clinical trial NCT03284463: Safety and Efficacy of Glibenclamide Combined With Rt-PA in Acute Cerebral Embolism
Official title: Safety and Efficacy of Glibenclamide Combined With Rt-PA in Treating Acute Ischemic Stroke: a Prospective, Randomized, Double-blind, Placebo-control, Multi-center Study
Acronym: SE-GRACE
Sponsor: Nanfang Hospital, Southern Medical University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 306.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-01
Primary completion date: 2022-08-28
Completion date: 2023-05-28
Plan to share individual participant data: NO
Clinical trial NCT04073147: Venetoclax and Obinutuzumab for Relapsed/Refractory Primary CNS Lymphoma
Official title: Chemotherapy Free Treatment With Venetoclax and Obinutuzumab for Relapsed / Refractory Primary CNS Lymphoma Patients (VENOBI-CNS Study) - A Phase IB Study to Assess the Pharmacokinetics in the Cerebrospinal Fluid
Acronym: VENOBI-CNS
Sponsor: Klinikum Stuttgart (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: low recruitment
Enrollment: 4.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-05-12
Primary completion date: 2021-11-25
Completion date: 2021-11-25
Plan to share individual participant data: YES
IPD sharing description: IPD will by made available on a data depository (e.g. https://datadryad.org/) after study completion and publication of results.
IPD time frame: after study completion and publication of results.
IPD access criteria: not decided yet
Clinical trial NCT03978884: Phase 4 Study of the Efficacy of Losartan Based Therapy in Hypertensives With and Without Diabetes
Official title: An Open Label, Single Arm Prospective Study to Evaluate Efficacy and Safety of Losartan Based Therapy Reslio® (Losartan) and Resilo-h® (Losartan+Hydrochlorthiazide) in Diabetic and Uncontrolled Hypertensive Patients
Sponsor: The University of The West Indies (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Unable to effective arrange trial logistics
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-06-01
Primary completion date: 2020-05-31
Completion date: 2020-12-31
Plan to share individual participant data: NO