Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413205
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2006-12-18
Brief Title:
TESRA Treatment of Emphysema With a Gamma-Selective Retinoid Agonist
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 21 ratio activeplacebo 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None