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NCT00463567 · ClinicalTrials.gov registry record · Phase 2
26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 2
- Development phase
- 2,059
- Enrollment target
NCT00463567: Completed Phase 2 study, sponsored by Novartis.
NCT00463567 is a Phase 2 study that has completed, run by Novartis. The registered enrollment target is 2,059 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1448% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00463567, a Phase 2 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2,059 participants
- Enrollment target
Study Summary
Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 \& 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD
Primary Outcome
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.
Interventions
- DRUG Indacaterol
- DRUG Formoterol (12 µg b.i.d.)
- DRUG Tiotropium (18 µg o.d.)
- DRUG Placebo to Indacaterol
- DRUG Placebo to Formoterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,059 participants |
| Start Date | 2007-04 |
| Est. Completion | 2008-08 |
| Phase | Phase 2 |
What the finished NCT00463567 record still lists
NCT00463567 is an interventional study that assigns participants to a tested intervention. Its 2,059 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1448% higher).
The record links to 0 conditions, and to 5 interventions - of which Indacaterol is the first listed.
NCT00463567 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00463567 about?
NCT00463567 is a clinical study titled "26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)". Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 \& 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selec...
What is the current status of trial NCT00463567?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2,059 participants. The study started on 2007-04. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00463567?
The interventions under investigation include: Indacaterol (DRUG), Formoterol (12 µg b.i.d.) (DRUG), Tiotropium (18 µg o.d.) (DRUG), Placebo to Indacaterol (DRUG), Placebo to Formoterol (DRUG).
Who is sponsoring clinical trial NCT00463567?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00463567's enrollment target sits among peer trials
2,059 8th of 2000 higher than 1,993 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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