A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)

Study acronym: CADENCE
StatusCompleted
PhasePhase 2
Started

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Record History

The 50 most recent of 54 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Results posted: Sep 23, 2026 Show 8 more changesShow less
    • Lead sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA to Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
    • Primary endpoint revised
    • Enrollment target: 164 to 165
    • Interventions: Placebo (Drug), Sotatercept 0.3 mg/kg (Drug), Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg (Drug) to Placebo (Drug), Sotatercept 0.3 mg/kg (Drug), Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg (Drug)
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints revised (15)
    • Site details revised at 5 of 119 sites
    • Publications: details revised at 1 of 1 entry
  2. Trial completedv53
  3. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Mar 30, 2026 to Apr 9, 2026
    v52
  4. Eligibility criteria revised
    • Secondary endpoints: 13 to 15
    v51
  5. Study completion date: Jan 30, 2026 to Mar 30, 2026v50
Show 45 earlier versionsHide 45 earlier versions
  1. Enrollment target: estimated 150 to confirmed 164
    • Primary completion date changed from estimate of Sep 12, 2025 to Sep 5, 2025
    • Study completion date: Dec 19, 2025 to Jan 30, 2026
    v49
  2. Study completion date: Sep 12, 2025 to Dec 19, 2025v48
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Oct 31, 2025 to Sep 12, 2025
    • Study completion date: Feb 20, 2027 to Sep 12, 2025
    • Site details revised at 119 of 119 sites
    v47
  4. Study sites: 117 to 119v46
  5. Re-verified, no change to tracked fieldsv45
  6. Secondary endpoints: 32 to 13
    • Study sites revised (117)
    • Study arms: 5 to 3
    v44
  7. Study sites: 116 to 117v43
  8. Study sites: 113 to 116v42
  9. Study sites: 112 to 113v41
  10. Study sites: 109 to 112
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 33 to 32
    v40
  11. Study sites: 106 to 109v39
  12. Study sites: 101 to 106v38
  13. Study sites: 94 to 101v37
  14. Study sites: 92 to 94v36
  15. Primary completion date: Oct 15, 2024 to Oct 31, 2025
    • Study sites: 90 to 92
    • Study completion date: May 19, 2026 to Feb 20, 2027
    v35
  16. Study sites: 89 to 90
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: 37 to 33
    v34
  17. Study sites: 86 to 89v33
  18. Site details revised at 20 of 86 sitesv32
  19. Site details revised at 6 of 86 sitesv31
  20. Site details revised at 4 of 86 sitesv30
  21. Study sites: 84 to 86v29
  22. Site details revised at 2 of 84 sitesv28
  23. Primary completion date: Jan 9, 2024 to Oct 15, 2024
    • Study sites: 82 to 84
    • Study completion date: Sep 9, 2025 to May 19, 2026
    v27
  24. Study sites: 81 to 82v26
  25. Study sites: 78 to 81v25
  26. Study sites: 74 to 78v24
  27. Study sites: 71 to 74v23
  28. Study sites: 70 to 71v22
  29. Study sites: 69 to 70v21
  30. Study sites revised (69)v20
  31. Study sites: 63 to 69v19
  32. Study sites: 58 to 63v18
  33. Study sites: 57 to 58v17
  34. Primary completion date: Aug 1, 2023 to Jan 9, 2024
    • Study completion date: Aug 22, 2025 to Sep 9, 2025
    • Site details revised at 1 of 57 sites
    v16
  35. Study sites: 54 to 57v15
  36. Enrollment target: 180 to 150
    • Study sites: 51 to 54
    • Interventions: Placebo (Drug), Sotatercept (Drug) to Placebo (Drug), Sotatercept 0.3 mg/kg (Drug), Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg (Drug)
    • Study arms: 3 to 5
    v14
  37. Study sites: 47 to 51v13
  38. Study sites revised (47)v12
  39. Study sites: 35 to 47v11
  40. Study sites: 33 to 35v10
  41. Study sites: 26 to 33v9
  42. Study sites: 21 to 26v8
  43. Start date: Nov 3, 2021 to Dec 29, 2021
    • Primary completion date: Aug 31, 2023 to Aug 1, 2023
    • Study completion date: Jun 30, 2025 to Aug 22, 2025
    v7
  44. Study sites: 5 to 21
    • Primary completion date: Aug 2023 to Aug 31, 2023
    • Study completion date: Jun 2025 to Jun 30, 2025
    v6
  45. Study sites: 2 to 5v5
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Merck (MSD)
411 trials monitored
See 26 trials at risk
Hypertension
1,935 trials monitored
See 96 trials at risk
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).
Trial Details
NCT Number NCT04945460
Lead Sponsor Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Conditions
(from sponsor)		 Hypertension, Pulmonary
Related terms Hypertension, Hypertension, Pulmonary
Enrollment 165 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov