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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00413205 |
This 2 arm study will investigate the efficacy, safety and tolerability of RAR Gamma versus placebo in ex-smokers with moderate or severe emphysema treated with optimal COPD therapy. Following optimization of COPD therapy (up to 6 weeks) patients will be randomized to receive either RAR Gamma (5mg) or placebo once daily using a 2:1 ratio (active:placebo), in addition to their standard therapy. Following the double-blind treatment period, patients will enter a 4-week follow-up period. The anticipated time on study period is 1-2 years, and the target sample size is 100-500 individuals.
Condition | Intervention | Phase |
---|---|---|
Emphysema |
Drug: RAR Gamma Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled Efficacy (as Assessed by Post-Bronchodilator FEV1) and Safety Study of RAR Gamma in Subjects With Smoking-Related, Moderate to Severe COPD With Emphysema Receiving Concurrent Optimised COPD Drug Therapy. |
Estimated Enrollment: | 727 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | November 2010 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: RAR Gamma
5mg po daily
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2: Placebo Comparator |
Drug: Placebo
po daily
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Ages Eligible for Study: | 44 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | NB19751 |
Study First Received: | December 18, 2006 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00413205 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pulmonary Emphysema Smoking Emphysema Lung Diseases, Obstructive |
Respiratory Tract Diseases Lung Diseases Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |
Pulmonary Emphysema Emphysema Lung Diseases, Obstructive Pathologic Processes |
Respiratory Tract Diseases Lung Diseases Pulmonary Disease, Chronic Obstructive |