Clinical trial
OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic…
NCT00076089 · AstraZeneca, Industry · Completed
Key facts
| NCT number | NCT00076089 |
|---|---|
| Title | OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111) |
| Official title | Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52-week, Multicenter, Double-blind Study With 500 mcg Roflumilast Once Daily Versus Placebo. |
| Lead sponsor | AstraZeneca, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Chronic Obstructive Pulmonary Disease, COPD |
| Intervention type | Drug |
| Interventions | Roflumilast |
| Enrollment | 1,100 |
| Start date | Dec 1, 2003 |
| Primary completion | Dec 1, 2005 |
| Completion | Dec 1, 2005 |
| First posted | Jan 15, 2004 |
| Last update posted | Dec 2, 2016 |
| Countries | Canada, France, Germany, Poland, South Africa, United States |
At a glance
- 10–99 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: