Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04732221
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2021-01-27
Brief Title:
A Study of the Efficacy and Safety of MK-5475 in Participants With Pulmonary Arterial Hypertension INSIGNIA-PAH Phase 23 Study of an Inhaled sGC Stimulator in PAH MK-5475-007
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 23 Multicenter Randomized Double-blind Placebo-Controlled Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2024-07
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:
None
Brief Summary:
This is a two-part Phase 2Phase 3 study of MK-5475 an inhaled soluble guanylate cyclase stimulator in participants with pulmonary arterial hypertension PAH
The first part Phase 2 will assess three different doses of MK-5475 compared to placebo in a base period of 12 weeks followed by comparison of three different doses of MK-5475 during an optional 24 month extension period The treatment dose with the best efficacy and safety profile in the phase 2 cohort base period will be selected for use in the second part Phase 3 of the study The primary hypothesis of Phase 2 is that at least one MK-5475 dose is superior to placebo in reducing pulmonary vascular resistance PVR from baseline at week 12
The purpose of the second part Phase 3 of the study is to confirm the efficacy safety and tolerability of MK-5475 at the selected dose compared to placebo during a 12 week base period followed by an extension period of up to 5 years The primary hypothesis of Phase 3 is that MK-5475 is superior to placebo in increasing 6-minute walk distance 6MWD from baseline at week 12
The first part Phase 2 will assess three different doses of MK-5475 compared to placebo in a base period of 12 weeks followed by comparison of three different doses of MK-5475 during an optional 24 month extension period The treatment dose with the best efficacy and safety profile in the phase 2 cohort base period will be selected for use in the second part Phase 3 of the study The primary hypothesis of Phase 2 is that at least one MK-5475 dose is superior to placebo in reducing pulmonary vascular resistance PVR from baseline at week 12
The purpose of the second part Phase 3 of the study is to confirm the efficacy safety and tolerability of MK-5475 at the selected dose compared to placebo during a 12 week base period followed by an extension period of up to 5 years The primary hypothesis of Phase 3 is that MK-5475 is superior to placebo in increasing 6-minute walk distance 6MWD from baseline at week 12
Detailed Description:
None
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 |
|---|---|---|---|
| 2020-001108-40 | EUDRACT_NUMBER | Merck | None |
| MK-5475-007 | OTHER | None | None |