NCT00917150

To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 771 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	tetomilast (OPC-6535)	oral administration of 12.5mg OPC-6535, once daily for 24months
DRUG	tetomilast (OPC-6535)	oral administration of 25mg OPC-6535, once daily for 24months
DRUG	tetomilast (OPC-6535)	oral administration of 50 mg OPC-6535, once daily for 24months
DRUG	placebo	oral administration of placebo, once daily for 24months

Timeline

• Start date: 2009-03-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2009-06-10
• Last updated: 2021-04-30
• Results posted: 2021-04-30

Locations

9 sites across 3 countries: China, Japan, South Korea