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NCT01756495 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of Losmapimod on Cardiac Conduction as Compared to Placebo and Moxifloxacin
A Phase 1 study of Acute Coronary Syndrome, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT01756495 is a Phase 1 study of Acute Coronary Syndrome that has completed, run by GlaxoSmithKline. The registered enrollment target is 56 participants, below the 2,720-participant average among 40 other Acute Coronary Syndrome trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01756495, a Phase 1 study of Acute Coronary Syndrome, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a double-blind, 4-period, randomized, cross-over study conducted in healthy adult subjects. The purpose of this study is to characterize the effect of orally administered losmapimod on the electrocardiogram (ECG) parameters with a focus on cardiac repolarization as measured by the corrected QT interval (QTc) duration, compared with placebo and moxifloxacin. Moxifloxacin (Avelox) is a drug with a known potential to create a mild QTc interval prolongation; therefore, it will serve as a positive control to validate the ability of this study to detect a change in the QTc interval. All subjects will participate in 4 study periods separated by a minimum washout period of 5 days. Each subject will receive one of 4 regimens (A = Losmapimod 7.5 milligram \[mg\] Twice daily \[BID\] x 5 days, B = Losmapimod 20 mg Once daily \[QD\] x 5 days, C = moxifloxacin 400 mg on Day 5, D = Losmapimod matched placebo and moxifloxacin placebo x 5 days) in each of the 4 planned study periods in a randomized, cross-over fashion. Subjects will be assigned to one of four treatment sequences following a Williams design (ABDC, BCAD, CDBA, DACB). Follow-up visit will occur 10 to 14 days after end of Period 4
Conditions Studied
Interventions
- DRUG Moxifloxacin
- DRUG Moxifloxacin Placebo
- DRUG Losmapimod
- DRUG Losmapimod matched Placebo
Study Locations (1)
Maryland
- GSK Investigational Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2013-01-10 |
| Est. Completion | 2013-04-23 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01756495
The ClinicalTrials.gov registry entry for NCT01756495 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,720-participant average among 40 other Acute Coronary Syndrome trials with a reported enrollment target (98% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute Coronary Syndrome appearing as the primary indexed condition, and to 4 interventions - of which Moxifloxacin is the first listed.
NCT01756495 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01756495 about?
NCT01756495 is a clinical study titled "A Study to Evaluate the Effect of Losmapimod on Cardiac Conduction as Compared to Placebo and Moxifloxacin". This will be a double-blind, 4-period, randomized, cross-over study conducted in healthy adult subjects. The purpose of this study is to characterize the effect of orally administered losmapimod on the electrocardiogram (ECG) parameters with a focus on cardiac repolarization as measured by the corre...
What is the current status of trial NCT01756495?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2013-01-10. Estimated completion is 2013-04-23.
What conditions does trial NCT01756495 study?
This clinical trial studies the following conditions: Acute Coronary Syndrome.
What interventions are being tested in trial NCT01756495?
The interventions under investigation include: Moxifloxacin (DRUG), Moxifloxacin Placebo (DRUG), Losmapimod (DRUG), Losmapimod matched Placebo (DRUG).
Who is sponsoring clinical trial NCT01756495?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01756495 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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