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NCT00846586 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,134
- Enrollment target
NCT00846586: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00846586 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,134 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00846586, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,134 participants
- Enrollment target
Study Summary
This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)
Primary Outcome
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Interventions
- DRUG Placebo to indacaterol
- DRUG Indacaterol 150 μg
- DRUG Tiotropium 18 μg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,134 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-03 |
| Phase | Phase 3 |
What the finished NCT00846586 record still lists
NCT00846586 is an interventional study that assigns participants to a tested intervention. Its 1,134 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo to indacaterol is the first listed.
NCT00846586 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00846586 about?
NCT00846586 is a clinical study titled "Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease". This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)
What is the current status of trial NCT00846586?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,134 participants. The study started on 2009-03. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00846586?
The interventions under investigation include: Placebo to indacaterol (DRUG), Indacaterol 150 μg (DRUG), Tiotropium 18 μg (DRUG).
Who is sponsoring clinical trial NCT00846586?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00846586's enrollment target sits among peer trials
1,134 244th of 2000 higher than 1,757 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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