CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Reldesemtiv +1 moredrug
Likely dose
Not stated in 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/NCT02662582
NCT02662582Phase 2Completed

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Two Period, Crossover Study to Assess the Effect of CK-2127107 on Physical Function in Subjects With Chronic Obstructive Pulmonary Disease

Astellas Pharma Global Development, Inc.·interventional·Posted Jan 25, 2016·Updated Nov 14, 2024

In Brief

A Phase 2 clinical trial evaluating Reldesemtiv and Placebo for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 46 participants across 2 sites.

Detailed Summary

The purpose of this study was to assess the effect of CK-2127107 relative to placebo on cycle ergometer exercise tolerance, assessed as change from period baseline in constant work rate (CWR) endurance time, utilizing a breath-by-breath metabolic measurement system with integrated electrocardiogram (ECG). The time to intolerance was assessed by a stopwatch and verified from electronic recordings of the cycle ergometer. This study assessed cardiopulmonary and neuromuscular effects of CK-2127107 relative to placebo; the effect of CK-2127107 on resting spirometry relative to placebo; the safety and tolerability of CK-2127107 as well as the pharmacokinetics of CK-2127107.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsCytokinetics

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 25, 2016
Enrollment StartJun 30, 2016
Primary CompletionJun 8, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.4 years ago

Interventions

Reldesemtivdrug

Oral tablet

Placebodrug

Oral tablet