To Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF)
NCT06264310 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2024-11-29
Summary
This Study Aims to Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF)
Conditions
- Heart Failure
- Worsening Heart Failure (WHF)
Interventions
- DRUG
-
Matching placebo SC injection
- DRUG
-
R2R01
Pharmaceutical Form: sterile 2R vials containing 10 mg of R2R01 for SC injection.
Sponsors & Collaborators
-
International HealthCare, LLC
collaborator OTHER -
River 2 Renal Corp.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-01
- Primary Completion
- 2024-11-04
- Completion
- 2024-11-25
- FDA Drug
- Yes
Countries
- United States
- Germany
- Italy
Study Locations
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