Clinical trial
26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With…
NCT00463567 · Novartis, Industry · Completed
Key facts
| NCT number | NCT00463567 |
|---|---|
| Title | 26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) |
| Official title | A 26-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of Two Doses of Indacaterol (Selected From 75, 150, 300 & 600 µg o.d.) in Patients With Chronic Obstructive Pulmonary… |
| Lead sponsor | Novartis, Industry |
| Status | Completed |
| Phase | Phase 2/Phase 3 |
| Study type | Interventional |
| Conditions | Pulmonary Disease, Chronic Obstructive, COPD, Lung Diseases, Obstructive |
| Intervention type | Drug |
| Interventions | Indacaterol, Formoterol (12 µg b.i.d.), Tiotropium (18 µg o.d.), Placebo to Indacaterol, Placebo to Formoterol |
| Enrollment | 2,059 |
| Start date | Apr 1, 2007 |
| Primary completion | Aug 1, 2008 |
| Completion | Aug 1, 2008 |
| First posted | Apr 20, 2007 |
| Last update posted | Aug 18, 2011 |
| Countries | Argentina, Canada, Germany, India, Italy, Puerto Rico, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United States |
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: