| Trial ID: | L7052 |
| Source ID: | NCT04507347
|
| Associated Drug: |
Trc041266
|
| Title: |
Efficacy and Safety of TRC041266 in Patients With Heart Failure, LVEF ≥40%, Diastolic Dysfunction and Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Stable Heart Failure
|
| Interventions: |
DRUG: TRC041266|DRUG: Placebo
|
| Outcome Measures: |
Primary: Primary composite endpoint consisting of incidence of cardiac mortality and/or number of worsening of heart failure and/or change from baseline to week 48 in functional capacity, Worsening of heart failure will be comprising of hospitalization for heart failure, or emergency visits for heart failure, or sustained increase in dose of diuretics Functional capacity shall be assessed by Physical Dimension-Minnesota Living with Heart Failure Questionnaire, and supervised 6-minute walk distance (measured in meters), 48 weeks |
|
| Sponsor/Collaborators: |
Sponsor: Torrent Pharmaceuticals Limited
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-06
|
| Completion Date: |
2024-06
|
| Results First Posted: |
|
| Last Update Posted: |
2022-12-27
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT04507347
|
