drugset / Trial / NCT01656395
A Dose-Ranging Study of MK-1029 in Adults With Persistent Asthma (MK-1029-012)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |