Ignite Creation Date:
2024-05-06 @ 2:38 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04370873
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2020-04-29
Brief Title:
MK-5475 in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease PH-COPD MK-5475-006
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Multiple Dose MK-5475 in Participants With Pulmonary Hypertension Associated With COPD
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:
The primary objectives of this study are to assess the safetytolerability and efficacy by evaluating changes in pulmonary vascular resistance PVR and pulmonary blood volume PBV of MK-5475 in participants with pulmonary hypotension associated with chronic obstructive pulmonary disease PH-COPD The primary hypothesis is that 28 days of MK-5475 treatment is superior to placebo treatment in reduction of PVR
Detailed Description:
Part 1 of this study will assess safety tolerability and PK of MK-5475 compared to placebo Part 2 will assess safety tolerability PK and changes in PVR and PBV of MK-5475 compared to placebo
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 |
|---|---|---|---|
| 2020-000488-22 | EUDRACT_NUMBER | Merck | None |
| MK-5475-006 | OTHER | None | None |