CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 604 enrolled
Drug / intervention
losmapimod +1 moredrug
Likely dose
losmapimod 2.5 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/NCT01218126
NCT01218126Phase 2Completed

A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging Study to Evaluate the Efficacy and Safety of Losmapimod (GW856553) Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease

GlaxoSmithKline·interventional·Posted Oct 11, 2010·Updated Feb 6, 2018

In Brief

A Phase 2 clinical trial evaluating losmapimod and placebo for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 604 participants across 48 sites in 8 countries.

Detailed Summary

Randomised, double-blind, parallel-group, multi-centre study evaluating three doses of losmapimod (2.5mg, 7.5 mg and 15 mg) twice daily (BID) versus placebo on exercise tolerance. Eligible subjects will be randomised to treatment after a one-week run-in period. The duration of the treatment period is 24 weeks. An estimated 1000 subjects will be screened to reach the target enrolment of approximately 600 randomised subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Czechia, Estonia, Germany, Norway, South Korea, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 11, 2010
Enrollment StartNov 4, 2010
Primary CompletionDec 21, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.7 years ago

Interventions

losmapimoddrug

comparison of different dosages of drug 2.5 mg, 7.5 mg or 15 mg

placebodrug

placebo comparison with active