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Revefenacin (TD-4208) in COPD (Study 0091)
NCT01704404Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2012
- Primary completion
- Nov 2013
- Countries
- 1
- Sponsor
- Mylan
- Modality
- Small Molecules
- Drugs
- revefenacin
- Conditions
- chronic obstructive pulmonary disease (COPD)
01
Overview
Phase 2, randomised, double-blind trial of revefenacin in chronic obstructive pulmonary disease (COPD) (7 arms), sponsored by Mylan. Primary endpoint: Change From Baseline to Day 7 in Trough Forced Expiratory Volume in 1 Second. Started Dec 2012; status: completed.
02
Design
7 arms- Study design
- RandomizedDouble-blind
22 µg TD-4208
44 µg TD-4208
88 µg TD-4208
175 µg TD-4208
350 µg TD-4208
700 µg TD-4208
1 more in the full profile.
03
Who it enrols
Patients aged 40-75 with moderate to severe COPD (FEV1/FVC < 0.7, post-bronchodilator FEV1 30-80%) and a positive response to ipratropium bromide.
04
Endpoints
Primary
Change From Baseline to Day 7 in Trough Forced Expiratory Volume in 1 Second
Secondary
Area Under the FEV1-Time Curve From 0 to 24 Hours
Area Under the FEV1-Time Curve From 12 to 24 Hours
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