chufangao/CTO huggingface dataset:
Clinical trial NCT03820466: Effect of Platelet Inhibition and / or Lipid Lowering in Non-ACS-patients With Positive Troponin
Official title: Investigator-initiated, Placebo-controlled, Randomized Trial to Assess the Efficacy and Safety of Platelet Inhibition and/ or Lipid Lowering in Non-ACS-patients With Elevated High-sensitivity Troponin Values
Acronym: GRAY-ZONE
Sponsor: Universitätsklinikum Hamburg-Eppendorf (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: insufficient recruitment due to the pandemic situation
Enrollment: 68.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-02-21
Primary completion date: 2021-12-02
Completion date: 2022-04-07
Plan to share individual participant data: NO
Clinical trial NCT05568225: A Study of Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)
Official title: A Phase 2 Open-Label Study to Evaluate Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Futility assessment concluded low likelihood of the trial showing meaningful patient benefit.
Enrollment: 17.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-11-22
Primary completion date: 2024-07-15
Completion date: 2024-07-15
Clinical trial NCT05682170: Study of the ZN-d5 and ZN-c3 in Subjects With Acute Myeloid Leukemia (AML)
Official title: A Phase 1/2 Dose Escalation Study of the BCL-2 Inhibitor ZN-d5 and the WEE1 Inhibitor ZN-c3 in Subjects With Acute Myeloid Leukemia
Sponsor: K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 40.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-12-01
Primary completion date: 2024-07-02
Completion date: 2024-07-26
Plan to share individual participant data: NO
Clinical trial NCT06165809: A Clinical Trial of TQB3015 Tablets in Patients With Advanced Malignant Cancer
Official title: A Phase I Study to Evaluate the Safety and Tolerance of TQB3015 Tablets With Advanced Malignant Cancer.
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: The sponsor voluntarily withdraw the project.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-12-31
Primary completion date: 2024-05-31
Completion date: 2024-05-31
Clinical trial NCT03693430: Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Official title: Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity
Acronym: STEP 5
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 304.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-05
Primary completion date: 2021-01-29
Completion date: 2021-03-23
Baseline population: The full analysis set (FAS) included all randomised participants according to the intention-to-treat principle.
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT04802161: Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes
Official title: Randomized Phase 2 Study of Daunorubicin and Cytarabine Liposome + Pomalidomide Versus Daunorubicin and Cytarabine Liposome in Newly Diagnosed AML With MDS-Related Changes
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Other - Pending amendment and futility analysis.
Enrollment: 78.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2022-08-24
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Plan to share individual participant data: YES
IPD sharing description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Clinical trial NCT04663321: Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006)
Official title: A Phase 2a, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-1942 Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Voluntarily terminated due to benefit/risk assessment
Enrollment: 99.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-05-20
Primary completion date: 2023-09-08
Completion date: 2023-09-08
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT05200143: Study of Ipilimumab, Nivolumab, and Cabozantinib in Patients With Cutaneous Melanoma
Official title: A Phase II, Single-Arm Clinical Trial Evaluating the Triplet Combination of Ipilimumab, Nivolumab, and Cabozantinib in Patients With Anti-PD-1(L1) Refractory Cutaneous Melanoma
Sponsor: Providence Health & Services (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Withdrawn support from BMS.
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-06-08
Primary completion date: 2023-09-11
Completion date: 2024-07-23
Clinical trial NCT06114121: Intrathecal Morphine vs. Intrathecal Morphine and Regional Anesthesia After Cesarean Section.
Official title: Comparing Intrathecal Morphine and Erector Spinae Plane Regional Anesthesia Against Intrathecal Morphine Alone for Post-Cesarean Section Pain
Sponsor: University of Miami (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Study will no longer be conducted
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2024-07-10
Primary completion date: 2024-09-10
Completion date: 2024-09-10
Plan to share individual participant data: NO
Clinical trial NCT03346434: Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL)
Official title: A Phase 2/3 Study Investigating the Pharmacokinetics, Safety, and Efficacy of Dupilumab in Patients Aged ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis
Acronym: Liberty AD
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 202.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-11-30
Primary completion date: 2021-07-08
Completion date: 2021-07-08
Clinical trial NCT03952143: A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes
Official title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 628.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-27
Primary completion date: 2021-01-20
Completion date: 2021-01-20
Baseline population: All randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: 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.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT04199351: Single and Multiple Ascending Dose Study of AMG 171 in Subjects With Obesity
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 171 in Subjects With Obesity
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Amgen determined the totality of the data does not support continuation of AMG 171 development program for treatment of Obesity. No safety concerns identified.
Enrollment: 60.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-12-13
Primary completion date: 2021-09-10
Completion date: 2021-09-10
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 (or other new use) 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 datasharing 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 link below.
Clinical trial NCT03737123: Trial of Atezolizumab Plus Chemotherapy After Progression on PD-1 or PD-L1 in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma
Official title: A Phase II Trial of Atezolizumab Plus Chemotherapy After Progression on PD-1 or PD-L1 Inhibitor in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma: HCRN GU17-295
Sponsor: Hoosier Cancer Research Network (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of accrual
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-12-19
Primary completion date: 2022-03-08
Completion date: 2022-05-18
Baseline population: No subject had been enrolled in arm B of Phase II
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03604978: Nivolumab and Multi-fraction Stereotactic Radiosurgery With or Without Ipilimumab in Treating Patients With Recurrent Grade II-III Meningioma
Official title: A Phase I/II Study of Nivolumab Plus or Minus Ipilimumab in Combination With Multi-Fraction Stereotactic Radiosurgery for Recurrent High-Grade Radiation-Relapsed Meningioma
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Why stopped: Scheduled Interim Monitoring
Enrollment: 38.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2019-06-17
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Clinical trial NCT05317078: A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications
Official title: Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 794 in Participants With Claudin 6-positive Advanced/Metastatic Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Amgen has made the business decision to discontinue development of AMG 794. The safety profile of AMG 794 remains unchanged.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-02-28
Primary completion date: 2023-12-19
Completion date: 2023-12-19
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 NCT04986072: Sodium Nitroprusside in Early Course Schizophrenia
Official title: Proof of Mechanism Study Using a Retinal Biomarker to Predict Treatment Response With Intravenous Sodium Nitroprusside in Symptomatic Early Course Schizophrenia
Sponsor: Beth Israel Deaconess Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Difficulty with recruiting subjects for the study
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-14
Primary completion date: 2024-06-01
Completion date: 2024-07-01
Plan to share individual participant data: NO
Clinical trial NCT02177695: S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer
Official title: A Randomized Phase II Study of Co-Expression Extrapolation (COXEN) With Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer
Acronym: COXEN
Sponsor: SWOG Cancer Research Network (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 237.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-08-28
Primary completion date: 2020-02-29
Completion date: 2022-12-01
Baseline population: All eligible participants
Plan to share individual participant data: YES
IPD sharing description: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
IPD time frame: Indefinite
IPD access criteria: NCTN/NCORP Data Archive registration
Clinical trial NCT03576885: Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia
Official title: Treatment of Delayed Pulmonary Transition in Extremely Preterm Infants & Bronchopulmonary Dysplasia
Sponsor: AdventHealth (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: based on DSMB recommendation at interim analysis
Enrollment: 182.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-07-15
Primary completion date: 2023-10-09
Completion date: 2023-10-09
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05291520: A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants
Official title: A Phase 1, Open-Label, Single-Dose Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, GSK3810109, Administered Either Subcutaneously or Intravenously With Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults
Acronym: SPAN
Sponsor: ViiV Healthcare (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-02-23
Primary completion date: 2023-04-10
Completion date: 2023-04-10
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, a 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 NCT04244253: A Phase 2 Trial of OPC-64005 for Major Depressive Disorder
Official title: A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison Trial to Assess Efficacy and Safety of OPC-64005 in Patients With Major Depressive Disorder
Sponsor: Otsuka Pharmaceutical Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 273.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-03-03
Primary completion date: 2022-02-08
Completion date: 2022-02-25
Baseline population: The safety analysis set includes all subjects who were administered at least 1 dose of double-blind IMP.
Plan to share individual participant data: YES
IPD sharing description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
IPD time frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
IPD access criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
Clinical trial NCT05526716: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)
Official title: A Phase 3 Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1080.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-09-23
Primary completion date: 2023-06-21
Completion date: 2023-06-21
Baseline population: All vaccinated participants are included.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT05773664: Dexamethasone and Azeliragon for Management of Post-Resection Cerebral Edema in Patients with Glioblastoma
Official title: A Phase I De-Escalation Study of Dexamethasone with Azeliragon for Management of Post-Resection Cerebral Edema in Patients with Glioblastoma
Sponsor: City of Hope Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2024-11-15
Primary completion date: 2024-11-29
Completion date: 2024-11-29
Clinical trial NCT04915846: Tamoxifen Therapy for Myotubular Myopathy
Official title: TAM4MTM: a Phase 1/2 Randomized, Placebo-Controlled, Double-Blinded, Single Crossover Study to Determine the Safety and Efficacy of Tamoxifen Therapy for Myotubular Myopathy (XLMTM)
Acronym: TAM4MTM
Sponsor: The Hospital for Sick Children (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study terminated due to safety concerns.
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-18
Primary completion date: 2024-05-09
Completion date: 2024-05-09
Plan to share individual participant data: NO
Clinical trial NCT04079088: Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS)
Official title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Decision to discontinue BIIB061 program was based on lack of stronger preclinical effects of BIIB061 on remyelination relative to opicinumab, that showed limited clinical efficacy in phase 2 clinical studies. This was not related to safety concerns.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-06-30
Primary completion date: 2024-09-18
Completion date: 2024-09-18
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 NCT01644253: Phase 1b Safety and Efficacy Study of TRU-016
Official title: Phase 1b, Open Label Study to Evaluate Safety and Efficacy of TRU-016 in Combination With Rituximab, Obinutuzumab, Rituximab and Idelalisib, or Ibrutinib in Chronic Lymphocytic Leukemia and With Bendamustine in Peripheral T-cell Lymphoma
Sponsor: Aptevo Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business decision
Enrollment: 87.0 (ACTUAL)
Number of arms: 8.0
Start date: 2012-09-30
Primary completion date: 2020-02-24
Completion date: 2021-04-21
Clinical trial NCT03351244: This Study Tests Whether BI 409306 Prevents Patients With Schizophrenia From Becoming Worse. This Study Looks at How Well Patients Tolerate BI 409306 and How Effective it is Over 6 Months
Official title: A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered BI 409306 During a 28-week Treatment Period as Adjunctive Therapy to Antipsychotic Treatment for the Prevention of Relapse in Patients With Schizophrenia.
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: disruption due to COVID-19
Enrollment: 264.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-12-07
Primary completion date: 2021-03-10
Completion date: 2021-03-31
Baseline population: Treated set (TS): the TS includes all patients who were randomised and were documented to have taken at least 1 dose of trial drug.
Limitations and caveats: The study was terminated due to sponsor decision. The planned number of participants to be recruited was not reached.