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

NCT00917150 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 771

Last updated 2021-04-30

Study results available
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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

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • China
  • Japan
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00917150 on ClinicalTrials.gov