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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 is a Phase 2 study that has completed, run by Novartis. The registered enrollment target is 2,059 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00463567
The ClinicalTrials.gov registry entry for NCT00463567 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 2,059 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Indacaterol is the first listed.
NCT00463567 reports 0 study locations.
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.
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