Trial · NCT04945460
A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)
NCT04945460, Phase 2, Completed, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16). Trials, record NCT04945460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04945460
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)
- NCT number
- NCT04945460
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 165 participants, actual
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Conditions
- Hypertension, Pulmonary
- Interventions
- Sotatercept 0.3 mg/kg, Placebo, Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg
- First posted
- 2021-06-30
- Last updated
- 2026-09-23
- Other registries' IDs
- eudract:2021-003020-32
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24 | Baseline and Week 24 | PVR, a hemodynamic variable of pulmonary circulation, was measured by right heart catheterization (RHC). Participants missing a value at baseline were excluded from the analysis. Participants missing a value at Week 24 (other than death or experienced a clinical worsening event), multiple imputation was used to impute missing data. Participants who died, the worst-rank score was assigned. Participants missing a value at Week 24 due to a clinical worsening event, the next-worst-rank score was used. The 'Full Range' is the minimum and maximum of the 100 medians from the 100 imputed datasets. |
| Secondary | Base Study: Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 24 | Baseline and Week 24 | The 6MWD was performed to assess functional capacity. The 6MWD was assessed using the 6-minute walk test (6MWT) to measure the distance covered over a time period of 6 minutes. An increase in the distance walked during the 6MWT indicated improvement in functional exercise capacity. Participants missing a value at baseline were excluded from the analysis. Participants missing a value at Week 24 (other than death or experienced a clinical worsening event), multiple imputation was used to impute missing data. Participants who died, the worst-rank score was assigned. Participants missing a value at Week 24 due to a clinical worsening event, the next-worst-rank score was used. The 'Full Range' is the minimum and maximum of the 100 medians from the 100 imputed datasets. |
| Secondary | Base Study: Time to First Clinical Worsening Event (TTCW) at Weeks 24 | 24 Weeks | Clinical Worsening events were defined as the number of weeks from first dose date to any of the following: * Hospitalization due to a cardiopulmonary indication (a non-elective hospitalization lasting at least 24 hours in duration caused by clinical conditions directly related to Pulmonary Hypertension and/or Heart Failure) * Administration of intravenous diuretics or subcutaneous (SC) furosemide * Death (all causes) * Decrease in 6 minute walk distance (6MWD) by ≥15% from baseline confirmed by 2 tests at least 4hours, but no more than 1 week apart. |
| Secondary | Base Study: Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Week 24 | Baseline and Week 24 | mPAP was calculated from systolic and diastolic pulmonary artery pressure measured by right heart catheterization. Participants missing a value at baseline were excluded from the analysis. Participants missing a value at Week 24 (other than death or experienced a clinical worsening event), multiple imputation was used to impute missing data. Participants who died, the worst-rank score was assigned. Participants missing a value at Week 24 due to a clinical worsening event, the next-worst-rank score was used. The 'Full Range' is the minimum and maximum of the 100 medians from the 100 imputed datasets. |
| Secondary | Base Study: Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Week 24 | Baseline and Week 24 | PCWP is an indirect estimate of left atrial pressure measured in right heart catheterization. Participants missing a value at baseline were excluded from the analysis. Participants missing a value at Week 24 (other than death or experienced a clinical worsening event), multiple imputation was used to impute missing data. Participants who died, the worst-rank score was assigned. Participants missing a value at Week 24 due to a clinical worsening event, the next-worst-rank score was used. The 'Full Range' is the minimum and maximum of the 100 medians from the 100 imputed datasets. |
| Secondary | Base Study: Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at Week 24 | Baseline and Week 24 | TAPSE is an echocardiographic measurement of tricuspid valve annulus movement, as an indicator of right heart function. Participants missing a value at baseline were excluded from the analysis. Participants missing a value at Week 24 (other than death or experienced a clinical worsening event), multiple imputation was used to impute missing data. Participants who died, the worst-rank score was assigned. Participants missing a value at Week 24 due to a clinical worsening event, the next-worst-rank score was used. The 'Full Range' is the minimum and maximum of the 100 medians from the 100 imputed datasets. |
| Secondary | Base Study: Change From Baseline in Right Ventricular Fractional Area Change (RVFAC) at Week 24 | Baseline and Week 24 | RVFAC is an echocardiographic measurement of percent change between right ventricular area during diastole and systole, as an indicator of right heart function. Participants missing a value at baseline were excluded from the analysis. Participants missing a value at Week 24 (other than death or experienced a clinical worsening event), multiple imputation was used to impute missing data. Participants who died, the worst-rank score was assigned. Participants missing a value at Week 24 due to a clinical worsening event, the next-worst-rank score was used. The 'Full Range' is the minimum and maximum of the 100 medians from the 100 imputed datasets. |
| Secondary | Base Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 24 | Baseline and Week 24 | LVEF is an echocardiographic measurement of percent change between left ventricular volume during diastole and systole, as an indicator of left heart function. Participants missing a value at baseline were excluded from the analysis. Participants missing a value at Week 24 (other than death or experienced a clinical worsening event), multiple imputation was used to impute missing data. Participants who died, the worst-rank score was assigned. Participants missing a value at Week 24 due to a clinical worsening event, the next-worst-rank score was used. The 'Full Range' is the minimum and maximum of the 100 medians from the 100 imputed datasets. |
| Secondary | Base Study: Change From Baseline in Isovolumic Relaxation Time (IVRT) at Week 24 | Baseline and Week 24 | IVRT is an echocardiographic measurement of the interval between closure of the aortic valve, to onset of filling by opening of the mitral valve. It was used as an indicator of diastolic dysfunction. Participants missing a value at baseline were excluded from the analysis. Participants missing a value at Week 24 (other than death or experienced a clinical worsening event), multiple imputation was used to impute missing data. Participants who died, the worst-rank score was assigned. Participants missing a value at Week 24 due to a clinical worsening event, the next-worst-rank score was used. The 'Full Range' is the minimum and maximum of the 100 medians from the 100 imputed datasets. |
| Secondary | Base Study: Change From Baseline in Ratio of Mitral Inflow Velocity E to Mitral Annular Velocity'(e') (E/e' Ratio) at Week 24 | Baseline and Week 24 | E/e' is a ratio of mitral inflow velocity E to mitral annular velocity (e') as measured by electrocardiography as an indicator of diastolic function. Participants missing a value at baseline were excluded from the analysis. Participants missing a value at Week 24 (other than death or experienced a clinical worsening event), multiple imputation was used to impute missing data. Participants who died, the worst-rank score was assigned. Participants missing a value at Week 24 due to a clinical worsening event, the next-worst-rank score was used. The 'Full Range' is the minimum and maximum of the 100 medians from the 100 imputed datasets. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41904795 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04945460
GET https://conductscience.org/api/trials/v1/NCT04945460/registered