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

NCT01656395 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2018-09-13

Study results available
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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.

Conditions

Interventions

DRUG

MK-1029

MK-1029 10 mg, 30 mg or 150 mg oral tablets taken QD at bedtime, based on randomization.

DRUG

Montelukast 10 mg

Parts I-II: Participants will receive Montelukast 10 mg tablets QD

DRUG

Placebo

Parts I-II: Participants will receive Placebo tablets QD

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01656395 on ClinicalTrials.gov