Efficacy and Safety of TRC041266 in Patients With Heart Failure, LVEF ≥40%, Diastolic Dysfunction and Type 2 Diabetes Mellitus
NCT04507347 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2022-12-27
Summary
This study will be conducted as a randomized, multi-centre, double-blind, parallel-group, placebo-controlled study in patients receiving SoC therapy. Eligible participants will be randomized in a ratio of 1:1 to receive either test product, TRC041266 1500 mg or matching placebo twice daily for 48 weeks
Conditions
- Chronic Stable Heart Failure
Interventions
- DRUG
-
TRC041266
TRC041266 sachet 1500 mg strengths
- DRUG
-
TRC041266 sachet 1500 mg matching placebo
Sponsors & Collaborators
-
Torrent Pharmaceuticals Limited
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-30
- Primary Completion
- 2024-06-30
- Completion
- 2024-06-30
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