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NCT00413205 · ClinicalTrials.gov registry record · Phase 2
TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 491
- Enrollment target
NCT00413205 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 491 participants.
The verdict
NCT00413205, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 491 participants
- Enrollment target
Study 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 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.
Interventions
- DRUG Placebo
- DRUG RAR Gamma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 491 participants |
| Start Date | 2007-01 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00413205
The ClinicalTrials.gov registry entry for NCT00413205 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 491 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00413205 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00413205 about?
NCT00413205 is a clinical study titled "TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)". 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) ...
What is the current status of trial NCT00413205?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 491 participants. The study started on 2007-01. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00413205?
The interventions under investigation include: Placebo (DRUG), RAR Gamma (DRUG).
Who is sponsoring clinical trial NCT00413205?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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