Conditions: Pulmonary Hypertension Left Heart Disease
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 4
Healthy volunteers: no

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 PHOOP/rEF 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:

Arms:
arm 1: Starting dose of 1 mg daily (oral); the dose may be titrated up on the 8th, 15th, and 22nd day of treatment to 2 mg, 3 mg, or 4 mg, respectively, for the duration of the study (28 days) as tolerated. For participants who reach one or more of the down-dosing criteria, there is an opportunity to decrease the dose back to a previously well-tolerated dose level, or to ½ of the starting dose.

Interventions: intervention 1: MK-8892
Intervention descriptions: intervention 1: None

Protocol document: