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NCT04945460 · ClinicalTrials.gov registry record · Phase 2
A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)
A Phase 2 study of Hypertension, Pulmonary, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ U.
- Active
- Registry status
- Phase 2
- Development phase
- 164
- Enrollment target
- 20
- Study locations
NCT04945460: Active Phase 2 study of Hypertension, Pulmonary, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ U.
NCT04945460 is a Phase 2 study of Hypertension, Pulmonary that is active but no longer recruiting, run by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ U. The registered enrollment target is 164 participants, below the 728-participant average among 10 other Hypertension, Pulmonary trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04945460, a Phase 2 study of Hypertension, Pulmonary, is active but no longer recruiting, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ U.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 164 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).
Primary Outcome
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sotatercept 0.3 mg/kg
- DRUG Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg
Study Locations (20)
California
- Scripps Clinic ( Site 4001) - La Jolla
- Cedars Sinai Medical Center ( Site 1082) - Los Angeles
- University of California Irvine ( Site 1086) - Orange
- Jeffrey S.Sager MD Medical Corporation ( Site 1060) - Santa Barbara
- Stanford University ( Site 1024) - Stanford
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028) - Torrance
Florida
- Bay Area Cardiology ( Site 1071) - Brandon
- Mayo Clinic Jacksonville - PPDS ( Site 1045) - Jacksonville
- AdventHealth Orlando ( Site 1058) - Orlando
- Tampa General Hospital ( Site 1043) - Tampa
Arizona
- PULMONARY ASSOCIATES, P.A. ( Site 1008) - Phoenix
- University of Arizona ( Site 1006) - Tucson
Colorado
- University Of Colorado ( Site 1013) - Aurora
- South Denver Cardiology Associates ( Site 1091) - Littleton
Georgia
- Piedmont Atlanta Hospital ( Site 1085) - Atlanta
- Emory University ( Site 1030) - Atlanta
Connecticut
- Winchester Chest Clinic ( Site 1093) - New Haven
District of Columbia
- The George Washington University Medical Faculty Associates ( Site 1025) - Washington D.C.
Idaho
- Saint Alphonsus Regional Medical Center ( Site 1097) - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2021-12-29 |
| Est. Completion | 2026-03-30 |
| Phase | Phase 2 |
Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ U3 total trials
What the registry record for NCT04945460 still lists
NCT04945460 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 728-participant average among 10 other Hypertension, Pulmonary trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Hypertension, Pulmonary appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04945460 names 20 study sites across 9 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT04945460 about?
NCT04945460 is a clinical study titled "A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)". This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with C...
What is the current status of trial NCT04945460?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2021-12-29. Estimated completion is 2026-03-30.
What conditions does trial NCT04945460 study?
This clinical trial studies the following conditions: Hypertension, Pulmonary.
What interventions are being tested in trial NCT04945460?
The interventions under investigation include: Placebo (DRUG), Sotatercept 0.3 mg/kg (DRUG), Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg (DRUG).
Who is sponsoring clinical trial NCT04945460?
This trial is sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ U, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04945460 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypertension, Pulmonary
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04945460's enrollment target sits among peer trials
164 4th of 10 higher than 7 of 10 other Hypertension, Pulmonary trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension, Pulmonary trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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