drugset / Trial / NCT01656395

A Dose-Ranging Study of MK-1029 in Adults With Persistent Asthma (MK-1029-012)

NCT01656395

Phase 2 Terminated 576 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This adaptive design, dose-ranging study of MK-1029 will assess the dose-related efficacy and safety of MK-1029 compared with placebo using measures of lung function (forced expiratory volume in 1 second \[FEV1\]). The primary objectives are (1) To demonstrate that MK-1029, compared with placebo, results in dose-related improvements in FEV1 over the last 6 weeks of the 12-week active-treatment period; and (2) To determine the dose-related safety and tolerability of MK-1029 as monotherapy and as concomitant dosing with montelukast over 12 weeks. The primary hypothesis is: MK-1029 is superior to placebo in a dose-related fashion in the average change from baseline in FEV1 over the last 6 weeks of the 12-week active-treatment period.

Timeline

Start
2012-08-23
Primary completion
2014-06-10
Completion
2014-07-08

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-1029 Unknown 1 mg Oral
Subject MK-1029 Unknown 3 mg Oral
Subject MK-1029 Unknown 10 mg Oral
Subject MK-1029 Unknown 30 mg Oral
Subject MK-1029 Unknown 60 mg Oral
Subject MK-1029 Unknown 150 mg Oral
Subject Montelukast Other / unclassified 10 mg

Indications