drugset / Trial / NCT02078557

A Multiple Dose Titration Study of MK-8892 in Participants With Pulmonary Hypertension and Left Heart Disease (MK-8892-007)

NCT02078557 ↗

Phase 1 Terminated 4 enrolled Merck Sharp & Dohme LLC
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-05-09
Primary completion
2014-08-15
Completion
2014-09-10

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-8892 Unknown 4 mg Oral