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)
Sponsor study identifier
Secondary identifiers
interventional
771
3 countries
9
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of trough FEV1 over time as the primary endpoint.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
June 8, 2009
Actual (reported)June 10, 2009
Actual (reported)April 2014
Actual (reported)April 2014
Actual (reported)April 30, 2021
Actual (reported)Trough Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline to 24 Months
Measurement over time (from baseline over the 24-month treatment period) and change from baseline to end of the treatment period.
Baseline, 24 months
Change From Baseline at 24 Months in Total Symptom Diary Score
Baseline, 24 months
Change From Baseline at 24 Months in St. George's Respiratory Questionnaire (SGRQ) Total Score
Baseline, 24 months
oral administration of 12.5mg OPC-6535, once daily for 24months
oral administration of 25mg OPC-6535, once daily for 24months
Central China Area, China
East China Area, China
North China Area, China
Northeast China Area, China
Northwest China Area, China
South China Area, China
Southwest China Area, China
Kansai Region, Et Al., Japan
771 participants (actual enrollment reported by the registry).
First Submitted
June 8, 2009
First Posted
June 10, 2009
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Efficacy Study of Treatment With Single Doses of CHF 4226 pMDI in Patients With Chronic Obstructive Pulmonary Disease (COPD)
oral administration of 50 mg OPC-6535, once daily for 24months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Seoul, Et Al., South Korea
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)Last Updated
April 30, 2021
Results First Posted
April 30, 2021
Record last verified: 2021-04
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Source: ClinicalTrials.gov.
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