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NCT01072448 · ClinicalTrials.gov registry record · Phase 3
12-week Efficacy of Indacaterol
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 323
- Enrollment target
NCT01072448: Completed Phase 3 study, sponsored by Novartis.
NCT01072448 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 323 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01072448, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 323 participants
- Enrollment target
Study Summary
This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.
Primary Outcome
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.
Interventions
- DRUG Placebo to indacaterol
- DRUG Indacaterol 75 μg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2010-01 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
What the finished NCT01072448 record still lists
NCT01072448 is an interventional study that assigns participants to a tested intervention. The registered 323 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo to indacaterol is the first listed.
NCT01072448 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01072448 about?
NCT01072448 is a clinical study titled "12-week Efficacy of Indacaterol". This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.
What is the current status of trial NCT01072448?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 323 participants. The study started on 2010-01. Estimated completion is 2010-07.
What interventions are being tested in trial NCT01072448?
The interventions under investigation include: Placebo to indacaterol (DRUG), Indacaterol 75 μg (DRUG).
Who is sponsoring clinical trial NCT01072448?
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 NCT01072448's enrollment target sits among peer trials
323 1081st of 2000 higher than 920 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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