Clinical trial
Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic…
NCT00393458 · Novartis, Industry · Completed
Key facts
| NCT number | NCT00393458 |
|---|---|
| Title | Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control |
| Official title | A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily)… |
| Lead sponsor | Novartis, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Chronic Obstructive Pulmonary Disease |
| Intervention type | Drug |
| Interventions | Indacaterol, Formoterol, Placebo to indacaterol, Placebo to formoterol |
| Enrollment | 1,732 |
| Start date | Oct 1, 2006 |
| Primary completion | Jul 1, 2008 |
| Completion | Jul 1, 2008 |
| First posted | Oct 27, 2006 |
| Last update posted | Aug 18, 2011 |
| Countries | Argentina, Chile, Colombia, Czechia, Denmark, Ecuador, Egypt, Estonia, France, Germany, Hungary, Israel and 13 more |
At a glance
- 100–999 Study sites
- Yes 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: