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NCT01218126 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
604
Enrollment target

NCT01218126: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT01218126 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 604 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (354% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01218126, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
604 participants
Enrollment target

Study 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.

Primary Outcome

Exercise tolerance was assessed using the 6MWD. If a participant was recorded as having used supplemental oxygen or a walking aid (including sitting down then continuing walking) or a technical problem during a 6MWD then that walk was considered as invalid; otherwise the 6MWD was considered as valid. The baseline 6MWD value was defined as the longest distance walked, for a valid walk, at Visit 2. Variability between the distances walked during the first six-minute walk test (6MWD1) and the secon

Interventions

  • DRUG placebo
  • DRUG losmapimod

Trial Details

FieldValue
Enrollment Target 604 participants
Start Date 2010-11-04
Est. Completion 2011-12-21
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT01218126 record still lists

NCT01218126 is an interventional study that assigns participants to a tested intervention. The registered 604 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (354% higher).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT01218126 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01218126 about?

NCT01218126 is a clinical study titled "Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging Study to Evaluate the Efficacy and Safety of Losmapimod Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD).". 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 i...

What is the current status of trial NCT01218126?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 604 participants. The study started on 2010-11-04. Estimated completion is 2011-12-21.

What interventions are being tested in trial NCT01218126?

The interventions under investigation include: placebo (DRUG), losmapimod (DRUG).

Who is sponsoring clinical trial NCT01218126?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01218126's enrollment target sits among peer trials

604 53rd of 2000 higher than 1,948 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01218126, the US trial registry maintained by the National Library of Medicine. NCT01218126 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.