Ignite Creation Date:
2024-05-06 @ 4:18 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04945460
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2021-06-11
Brief Title:
A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF MK-7962-007A011-16
Sponsor:
Acceleron Pharma Inc a wholly-owned subsidiary of Merck Co Inc Rahway NJ USA
Organization:
Acceleron Pharma Inc a wholly-owned subsidiary of Merck Co Inc Rahway NJ USA
Study Overview
Official Title:
A Phase 2 Double-blind Randomized Placebo-controlled Study to Evaluate the Effects of Sotatercept Versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension Cpc-PH Due to Heart Failure With Preserved Ejection Fraction HFpEF
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CADENCE
Brief 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
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
Detailed Description:
Participants enrolled in the study will have a diagnosis of Cpc-PH due to HFpEF with New York Heart Association NYHA functional class FC II or III Participants will be randomly assigned in a 111 ratio to 1 of the 3 treatment groups placebo 03mgkg sotatercept and 07mgkg sotatercept during the placebo-controlled Treatment Period In the extension phase sotatercept-treated participants will continue on their current dose Placebo participants will be re-randomized in a 11 ratio to one of the two sotatercept treatment groups utilized in the placebo-controlled Treatment Period Each participant will be enrolled in the study for up to 114 weeks including a 28-day Screening Period a 24-week double-blind placebo-controlled Treatment Period an 18-month Extension Period and an 8-week Follow-up Period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-003020-32 | EUDRACT_NUMBER | Merck | None |
| A011-16 | OTHER | None | None |
| MK-7962-007 | OTHER | None | None |