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

PHASE2CompletedINTERVENTIONAL
Enrollment

771

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
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

Trial Locations (9)

Unknown

Central China Area

East China Area

North China Area

Northeast China Area

Northwest China Area

South China Area

Southwest China Area

Kansai Region, Et Al.

Seoul, Et Al.

All Listed Sponsors
lead

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

NCT00917150 - To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients | Biotech Hunter | Biotech Hunter