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drugset / Trial / NCT01025843

Safety and Tolerability of MK-5478 in Participants With Hypertension (5478-001)

NCT01025843 ↗

Phase 1 Completed 20 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a two part introductory clinical trial with MK-5478. Part I will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of MK-5478 in young, healthy males. Part II will evaluate the safety, tolerability and pharmacodynamic effects of MK-5478 in participants with hypertension. The primary hypothesis is that single oral doses of MK-5478 are sufficiently safe and well tolerated.

Timeline

Start
2009-12-01
Primary completion
2010-05-01
Completion
2010-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Candesartan cilexetil Unknown 32 mg Oral
Subject MK-5478 Unknown 1 mg Oral
Subject MK-5478 Unknown 2 mg Oral
Subject MK-5478 Unknown 5 mg Oral
Subject MK-5478 Unknown 8 mg Oral
Subject MK-5478 Unknown 12 mg Oral
Subject MK-5478 Unknown 18 mg Oral
Subject MK-5478 Unknown 24 mg Oral
Subject MK-5478 Unknown 38 mg Oral

Indications

hypertensive disorder