Status:
COMPLETED
To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Age 40 to 75 years, inclusive, at the time informed consent is obtained
- Ability to provide own written informed consent
- Agree to use an appropriate method of contraception until 3 months after the last dose of the investigational medicinal product (IMP)
- A rating of 1 or higher on the Goddard scale in assessment of emphysema severity by chest CT scan at screening
- Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) of less than 70% at screening
- Cigarette smoking history of at least 20 pack years at screening
Exclusion
- Subjects with obstructive disorders due to bronchial asthma
- Subjects receiving long-term oxygen therapy
- Subjects with active tuberculosis or obvious bronchiectasis
- Complication of malignant tumor
- Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders
- Uncontrolled condition with COPD exacerbation of level 2 or 3 within 8 weeks prior to the start of washout period (within 12 weeks prior to start of treatment period)
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
771 Patients enrolled
Trial Details
Trial ID
NCT00917150
Start Date
March 1 2009
End Date
April 1 2014
Last Update
April 30 2021
Active Locations (9)
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1
Central China Area, China
2
East China Area, China
3
North China Area, China
4
Northeast China Area, China