A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16) (NCT04945460) | Clinical Trial Compass
CompletedPhase 2
A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)
United States164 participantsStarted 2021-12-29
Plain-language 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).
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Age 18 to 85 years
✓. Clinical diagnosis of HFpEF:
✓. Demonstrated Cpc-PH by all of the following:
✓. New York Heart Association FC of II or III
✓. Six-minute Walk Distance ≥100 m repeated twice during Screening and both values within 15% of each other, calculated from the highest value
✓. Chronic medication for HF or for any underlying condition, administered at a stable (per investigator) dose for ≥30 days prior to Visit 1. Diuretics and/or anticoagulants are excepted from this rule but should not be newly started or stopped within 30 days of Visit 1, and a prescribed dose change should not occur within 7 days of Visit 1. Anticoagulation may be suspended for RHC if necessary
✓. Women of childbearing potential must:
✓. Male participants must:
Exclusion criteria
✕. A diagnosis of PH in WHO Group 1, WHO Group 3, WHO Group 4, or WHO Group 5
✕. Clinically significant and active lung disease:
✕. Cardiovascular co-morbidities, which include any of the following:
✕. Hospitalization for any worsening of medical conditions or any significant surgery per investigator within 30 days of Visit 1
What they're measuring
1
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24
Timeframe: Baseline and Week 24
Trial details
NCT IDNCT04945460
SponsorAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
. Received any approved PAH-specific therapies (i.e., endothelin receptor antagonists, prostacyclin analogs, phosphodiesterase-5 inhibitors, soluble guanylate cyclase stimulators) within 30 days of Visit 1.The use of an oral phosphodiesterase type 5 inhibitor, if only indicated for erectile dysfunction, is permitted, if not administered within 48 hours of a study visit or procedure
✕. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin, or levosimendan) within 30 days of Visit 1
✕. Received erythropoietin within 6 months of Visit 1
✕. Known history of chronic liver disease, including untreated hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), with severe hepatic impairment and/or cirrhosis (e.g., hepatic encephalopathy)