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NCT00821093 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,123
- Enrollment target
NCT00821093: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00821093 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,123 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00821093, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,123 participants
- Enrollment target
Study Summary
This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.
Primary Outcome
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; 1, 2, 3, 4, and 8 hours; 11 hours 10 minutes and 11 hours 45 minutes 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 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.
Interventions
- DRUG Placebo to indacaterol
- DRUG Placebo to salmeterol
- DRUG Indacaterol 150 µg
- DRUG Salmeterol 50 µg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,123 participants |
| Start Date | 2009-01 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
What the finished NCT00821093 record still lists
NCT00821093 is an interventional study that assigns participants to a tested intervention. Its 1,123 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 (45% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo to indacaterol is the first listed.
NCT00821093 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00821093 about?
NCT00821093 is a clinical study titled "Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD)". This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.
What is the current status of trial NCT00821093?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,123 participants. The study started on 2009-01. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00821093?
The interventions under investigation include: Placebo to indacaterol (DRUG), Placebo to salmeterol (DRUG), Indacaterol 150 µg (DRUG), Salmeterol 50 µg (DRUG).
Who is sponsoring clinical trial NCT00821093?
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 NCT00821093's enrollment target sits among peer trials
1,123 248th of 2000 higher than 1,752 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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