chufangao/CTO huggingface dataset:
Clinical trial NCT02589600: Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)
Official title: ZEST II for Osteoporotic Fracture Prevention
Acronym: ZEST II
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 310.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-31
Primary completion date: 2022-06-22
Completion date: 2022-06-22
Baseline population: Same as participant flow
Clinical trial NCT03279289: Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Population With mCRC After Failure of an Oxaliplatin-based Regimen
Official title: Randomised, Multicentre, Phase II Pilot Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Population With Metastatic Colorectal Cancer (mCRC) After Failure of an Oxaliplatin-based Regimen
Acronym: AFEMA
Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 170.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-25
Primary completion date: 2023-02-09
Completion date: 2023-02-09
Plan to share individual participant data: NO
Clinical trial NCT02122913: A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer
Official title: A Phase 1 Study of the Oral TRK Inhibitor Larotrectinib in Adult Patients With Solid Tumors
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 75.0 (ACTUAL)
Number of arms: 7.0
Start date: 2014-05-04
Primary completion date: 2017-02-01
Completion date: 2021-04-09
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 NCT03247244: Safety and Efficacy of Cannabis in Tourette Syndrome
Official title: A Double-blind, Randomized, Placebo-controlled Crossover Pilot Trial of Medical Cannabis in Adults With Tourette Syndrome
Sponsor: University Health Network, Toronto (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Recruitment/enrollment took too long
Enrollment: 15.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-01-15
Primary completion date: 2019-06-06
Completion date: 2020-01-27
Clinical trial NCT03602560: ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Official title: A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 265.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-10-01
Primary completion date: 2020-02-16
Completion date: 2020-02-16
Clinical trial NCT02971033: Ezetimibe as a Safe and Efficacious Treatment for Chronic Hepatitis C
Official title: Ezetimibe as a Safe and Efficacious Treatment for Chronic Hepatitis C
Sponsor: VA Office of Research and Development (FED)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study Funding ended
Enrollment: 2.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-04-16
Primary completion date: 2021-03-31
Completion date: 2021-03-31
Baseline population: no patients were randomized to 40mg/day ezetimibe group
Limitations and caveats: 1. A major limitation is that the study was that it was interrupted by the CoVID-19 pandemic and then was terminated early leading to small numbers of subjects analyzed. It is not possible to derive conclusions comparing the single patients enrolled in arms 1 and 2.~2. The patient in arm 2 had study medication remaining at the first pill count indicating that EZE dosing was lower than 20mg/day during at least part of the treatment period.
Plan to share individual participant data: NO
Clinical trial NCT03852433: Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD)
Official title: A Multicenter, Open-label, Randomized Phase 2b Clinical Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Patients With Chronic Hepatitis Delta
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 175.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-05-31
Primary completion date: 2022-04-05
Completion date: 2022-09-28
Baseline population: All Randomized Analysis Set included all participants who were enrolled (informed consent signed) and randomized in the study.
Plan to share individual participant data: NO
Clinical trial NCT03005184: Mechanism(s) Underlying Cardiovascular Effects of ARB/NEP Inhibition - Aim 2
Official title: Mechanism(s) Underlying Cardiovascular Effects of ARB/NEP Inhibition - Aim 2
Sponsor: Vanderbilt University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study is being redesigned and submitted as a new study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 12.0
Start date: 2017-09-30
Primary completion date: 2020-01-31
Completion date: 2020-01-31
Plan to share individual participant data: NO
Clinical trial NCT03320876: An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.
Official title: A Multicenter, Open-label, Long-term Extension Safety and Efficacy Study of Filgotinib Treatment in Subjects With Moderately to Severely Active Psoriatic Arthritis.
Sponsor: Galapagos NV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: development program for filgotinib for participants with psoriatic arthritis has been stopped
Enrollment: 122.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-07-26
Primary completion date: 2021-06-30
Completion date: 2021-06-30
Plan to share individual participant data: NO
Clinical trial NCT05567952: A Study to Learn About a Repeat 5-Day Treatment With the Study Medicines (Called Nirmatrelvir/Ritonavir) in People 12 Years Old or Older With Return of COVID-19 Symptoms and SARS-CoV-2 Positivity After Finishing Treatment With Nirmatrelvir/Ritonavir
Official title: AN INTERVENTIONAL, EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE A REPEAT 5-DAY COURSE OF NIRMATRELVIR/RITONAVIR COMPARED TO PLACEBO/RITONAVIR IN PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH REBOUND OF COVID-19 SYMPTOMS AND RAPID ANTIGEN TEST POSITIVITY
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 436.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-10-19
Primary completion date: 2023-09-27
Completion date: 2024-02-09
Baseline population: Full analysis set (FAS) included all participants randomly assigned to study intervention.
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 NCT05329623: A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants.
Official title: A Phase 1, Open-label, Single-dose, Multi-center, Parallel Group Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Matched Healthy Control Participants.
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 33.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-05-03
Primary completion date: 2024-04-07
Completion date: 2024-04-07
Plan to share individual participant data: NO
Clinical trial NCT02403674: Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021)
Official title: A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naïve HIV-1 Infected Subjects
Acronym: DRIVE-AHEAD
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 734.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-06-05
Primary completion date: 2017-03-20
Completion date: 2023-09-07
Baseline population: The Baseline Analysis Population consists of all randomized participants who received ≥1 dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT03822416: Treating Smokers With Mental Illness
Official title: Treating Tobacco Dependence in Smokers With Severe Mental Illness
Sponsor: University of Minnesota (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 38.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-01
Primary completion date: 2020-05-04
Completion date: 2020-05-04
Plan to share individual participant data: NO
Clinical trial NCT04452006: A Study in Healthy Subjects to Investigate the Safety and Tolerability of ACT- 541478 as Well as What ACT-541478 Does to the Body and the Way the Body Takes up, Distributes, and Gets Rid of ACT-541478
Official title: Single-center, Double-blind, Randomized, Placebo-controlled, Three-part, First-in-human, Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-541478 in Healthy Subjects
Sponsor: Idorsia Pharmaceuticals Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Based on interim analysis, the Sponsor decided to terminate the study prematurely.
Enrollment: 56.0 (ACTUAL)
Number of arms: 11.0
Start date: 2020-07-20
Primary completion date: 2021-04-20
Completion date: 2021-04-20
Plan to share individual participant data: NO
Clinical trial NCT04927975: Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Non-Segmental Vitiligo
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 185.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-06-30
Primary completion date: 2023-01-13
Completion date: 2023-08-29
Baseline population: ITT Population in Period 1 (ITT_1): all randomized participants in Period 1, analyzed according to the treatment groups that they were randomized to.
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Clinical trial NCT02335944: Study of Safety and Efficacy of EGFR-TKI EGF816 in Combination With cMET Inhibitor INC280 in Adult Patients With EGFR Mutated Non Small Cell Lung Cancer.
Official title: A Phase Ib/II, Multicenter, Open-label Study of EGF816 in Combination With INC280 in Adult Patients With EGFR Mutated Non-small Cell Lung Cancer.
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Company decision
Enrollment: 177.0 (ACTUAL)
Number of arms: 6.0
Start date: 2015-01-13
Primary completion date: 2020-11-10
Completion date: 2020-11-10
Baseline population: No participants were enrolled in Phase II-Group 5 arm due to early study termination.
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 NCT06102174: A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV
Official title: AN INTERVENTIONAL, PHASE 1b, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, MULTI-CENTER, DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SISUNATOVIR IN PEDIATRIC PARTICIPANTS UP TO AGE 60 MONTHS WITH RESPIRATORY SYNCYTIAL VIRUS (RSV) LOWER RESPIRATORY TRACT INFECTION (LRTI)
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study discontinued due to business reasons. There were no safety concerns in the decision to stop study and no changes to sponsor's assessment of the risk-benefit profile for participants who received sisunatovir in the study
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2024-02-15
Primary completion date: 2024-09-03
Completion date: 2024-09-03
Plan to share individual participant data: NO
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 NCT03361345: Topical 5% Tranexamic Acid as a Treatment for Postinflammatory Hyperpigmentation Due to Acne Vulgaris
Official title: Topical 5% Tranexamic Acid as a Treatment for Postinflammatory Hyperpigmentation Due to Acne Vulgaris
Sponsor: Wayne State University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Lack of recruitment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-01
Primary completion date: 2022-01-09
Completion date: 2022-01-09
Plan to share individual participant data: NO
Clinical trial NCT04816526: Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
Official title: Phase 2 Study of Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
Sponsor: Cartesian Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 13.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-01
Primary completion date: 2022-08-04
Completion date: 2022-11-03
Clinical trial NCT04830462: Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation
Official title: Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation
Sponsor: Herlev and Gentofte Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-15
Primary completion date: 2023-05-01
Completion date: 2023-05-01
Clinical trial NCT04700787: Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents
Official title: A Phase 1, Multi-Center, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Sulopenem and Sulopenem Etzadroxil + Probenecid in Adolescent Patients With Bacterial Infection
Sponsor: Iterum Therapeutics, International Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Enrollment challenges and change in development plan necessitating a change in study design
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-30
Primary completion date: 2022-03-25
Completion date: 2022-04-04
Plan to share individual participant data: NO
Clinical trial NCT02729714: A Pilot Study of Suvorexant for Insomnia in Parkinson Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Suvorexant for Insomnia in Parkinson Disease
Sponsor: Burdick, Daniel, M.D. (INDIV)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-04-30
Primary completion date: 2022-04-30
Completion date: 2022-04-30
Limitations and caveats: Designed as a pilot study, so recruitment goal was low and consequently the sample size is small, limiting interpretation of the significance of the differences between suvorexant and placebo.
Clinical trial NCT05900648: Regorafenib and XmAb20717 in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy (RX-CROME)
Official title: Regorafenib and XmAb20717 in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy (RX-CROME)
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: 0 participant accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-05-17
Primary completion date: 2024-02-09
Completion date: 2024-02-09
Clinical trial NCT02464657: Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
Official title: Phase I/II Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 44.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-07-31
Primary completion date: 2020-05-07
Completion date: 2020-05-07
Clinical trial NCT03498391: A Study of Human Multi-Sensory Integration
Official title: A Study of Human Multi-Sensory Integration: A Neurophysiologic Correlate of Conscious Perception
Acronym: MSI
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Due to the impact of COVID-19
Enrollment: 40.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2018-07-30
Primary completion date: 2023-05-31
Completion date: 2023-05-31
Plan to share individual participant data: NO
Clinical trial NCT03996369: Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
Acronym: ELEVATE UC 12
Sponsor: Arena Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 354.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-15
Primary completion date: 2021-12-07
Completion date: 2021-12-07
Baseline population: Full Analysis Set: All randomized participants who received at least 1 dose of study intervention.
Plan to share individual participant data: NO
Clinical trial NCT04267276: A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body
Official title: Investigation of Metabolism and Pharmacokinetics of BI 1265162 (C-14) After Intravenous Administration (Part 1) and Investigation of Metabolism and Pharmacokinetics of BI 1265162 (C-14) After Oral Administration (Part 2) in Healthy Male Subjects Following a Non-randomized, Open-label, Single-dose, Single Arm Per Trial Part Mass Balance Design
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to the COVID-19 pandemic, the recruitment of new subjects was temporarily halted in March 2020. The study was permanently discontinued in December 2020.
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-18
Primary completion date: 2020-04-02
Completion date: 2020-04-02
Baseline population: Treated set (TS): The treated set includes all participants who were entered and treated with one dose of trial drug. The treated set will be used for safety analyses.
Limitations and caveats: The study was interrupted due to COVID-19 crisis on 02-Apr-2020, after completion of Part 1. Further, the sponsor decided to discontinue the development of BI 1265162. Enrolment in Part 2 (oral administration of BI 1265162 (C-14)) did not take place. Decision to terminate trial was taken on 17-Dec-2020.
Plan to share individual participant data: NO
IPD sharing description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: http://trials.boehringer-ingelheim.com/