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NCT01005901 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,324
- Enrollment target
NCT01005901: Completed Phase 3 study, sponsored by Novartis.
NCT01005901 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 1,324 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01005901, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,324 participants
- Enrollment target
Study Summary
A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
Primary Outcome
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
Interventions
- DRUG Placebo
- DRUG Glycopyrronium bromide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,324 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
What the finished NCT01005901 record still lists
NCT01005901 is an interventional study that assigns participants to a tested intervention. Its 1,324 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 (72% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01005901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01005901 about?
NCT01005901 is a clinical study titled "A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo". A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
What is the current status of trial NCT01005901?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,324 participants. The study started on 2009-10. Estimated completion is 2010-12.
What interventions are being tested in trial NCT01005901?
The interventions under investigation include: Placebo (DRUG), Glycopyrronium bromide (DRUG).
Who is sponsoring clinical trial NCT01005901?
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 NCT01005901's enrollment target sits among peer trials
1,324 184th of 2000 higher than 1,816 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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