Ignite Creation Date:
2024-05-06 @ 2:35 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02078557
Status:
TERMINATED
Last Update Posted:
2018-10-31
First Post:
2014-03-03
Brief Title:
A Multiple Dose Titration Study of MK-8892 in Participants With Pulmonary Hypertension and Left Heart Disease MK-8892-007
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Multiple Dose Titration Trial to Study the Safety Tolerability Pharmacokinetics and Pharmacodynamics of MK-8892 in Patients With Pulmonary Hypertension and Left Heart Disease
Status:
TERMINATED
Status Verified Date:
2018-03
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 study will assess multiple doses of MK-8892 administered to participants with pulmonary hypertension out of proportion PHOOP and heart failure with reduced left ventricular ejection fraction rEF It is hypothesized that generally safe and well tolerated multiple doses of MK-8892 will achieve a true reduction from baseline in pulmonary vascular resistance PVR greater than 12
Sixteen participants with PHOOPrEF were to receive multiple doses of MK-8892 titrated to the highest tolerated dose for each participant up to 4 mg daily and to undergo evaluation for safety and systemic hemodynamics and cardiac function Only 4 participants were enrolled and completed the study due to a strategic business decision by the sponsor to terminate the clinical conduct of all MK-8892 ongoing trials including this trial
Sixteen participants with PHOOPrEF were to receive multiple doses of MK-8892 titrated to the highest tolerated dose for each participant up to 4 mg daily and to undergo evaluation for safety and systemic hemodynamics and cardiac function Only 4 participants were enrolled and completed the study due to a strategic business decision by the sponsor to terminate the clinical conduct of all MK-8892 ongoing trials including this trial
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2013-004639-55 | EUDRACT_NUMBER | None | None |
| MK-8892-007 | OTHER | Merck Protocol Number | None |