At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 771 enrolled
Drug / intervention
tetomilast (OPC-6535) +3 moredrug
Likely dose
tetomilast (OPC-6535) 12.5mgfrom 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.
A Phase 2, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Dose-comparison Trial of OPC-6535 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 2 clinical trial evaluating tetomilast (OPC-6535) and placebo for Chronic Obstructive Pulmonary Disease. Completed, enrolled 771 participants across 9 sites in 3 countries.
Detailed Summary
To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of trough FEV1 over time as the primary endpoint.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesChina, Japan, South Korea
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedJun 2009
Primary CompletionApr 2014
TodayJul 2026
First PostedJun 10, 2009
Enrollment StartMar 1, 2009
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 17.1 years ago
Interventions
tetomilast (OPC-6535)drug
oral administration of 12.5mg OPC-6535, once daily for 24months
tetomilast (OPC-6535)drug
oral administration of 25mg OPC-6535, once daily for 24months
tetomilast (OPC-6535)drug
oral administration of 50 mg OPC-6535, once daily for 24months
placebodrug
oral administration of placebo, once daily for 24months