CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 107 enrolled
Drug / intervention
MK-1029 +2 moredrug
Likely dose
MK-1029 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01624974
NCT01624974Phase 2Completed
CompareCT.gov

A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Crossover Study of MK-1029 in Adult Subjects With Persistent Asthma Who Remain Uncontrolled While Being Maintained on Montelukast

Merck Sharp & Dohme LLC·interventional·Posted Jun 21, 2012·Updated Jan 2, 2019

In Brief

A Phase 2 clinical trial evaluating MK-1029, Placebo, and 1 other intervention for Asthma. Completed, enrolled 107 participants.

Detailed Summary

The purpose of this study is to evaluate the effect of MK-1029 on lung function in the treatment of adults who have persistent asthma that is uncontrolled with the use of montelukast (ML). Participants will use randomized study drug (either MK-1029 or placebo) for two separate 4-week treatment periods. All participants will also use ML during the treatment periods. The primary hypothesis is that MK-1029 is superior to placebo in change from baseline in forced expiratory volume in one second (FEV1) at the end of the 4-week treatment period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 21, 2012
Enrollment StartAug 9, 2012
Primary CompletionMay 5, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.0 years ago

Interventions

MK-1029drug

MK-1029 150 mg tablets taken QD

Placebodrug

Placebo tablets (matching the MK-1029 150 mg tablets) QD

Montelukast (ML)drug

ML 10 mg tablets QD