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NCT01119950 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 388
- Enrollment target
NCT01119950: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01119950 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 388 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (192% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01119950, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 388 participants
- Enrollment target
Study Summary
This study was designed to investigate the efficacy and safety of NVA237, a long-acting muscarinic antagonist, in patients with moderate to severe COPD.
Primary Outcome
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. The maximal response of incremental once daily and twice daily doses of NVA237 that each dose achieves in relation to the maximal effect of NVA237 on Trough FEV1 was measured at Day 28. FEV1 was measured in response to all doses administered (see Outcome Measure #19). All trough FEV1 responses to active doses were corrected using the placebo response. A mo
Interventions
- DRUG NVA237 12.5 µg once daily
- DRUG NVA237 25.0 µg once daily
- DRUG NVA237 12.5 µg twice daily
- DRUG NVA237 50.0 µg once daily
- DRUG NVA237 25.0 µg twice daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 388 participants |
| Start Date | 2010-04 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
What the finished NCT01119950 record still lists
NCT01119950 is an interventional study that assigns participants to a tested intervention. The registered 388 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (192% higher).
The record links to 0 conditions, and to 5 interventions - of which NVA237 12.5 µg once daily is the first listed.
NCT01119950 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01119950 about?
NCT01119950 is a clinical study titled "Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)". This study was designed to investigate the efficacy and safety of NVA237, a long-acting muscarinic antagonist, in patients with moderate to severe COPD.
What is the current status of trial NCT01119950?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 388 participants. The study started on 2010-04. Estimated completion is 2010-12.
What interventions are being tested in trial NCT01119950?
The interventions under investigation include: NVA237 12.5 µg once daily (DRUG), NVA237 25.0 µg once daily (DRUG), NVA237 12.5 µg twice daily (DRUG), NVA237 50.0 µg once daily (DRUG), NVA237 25.0 µg twice daily (DRUG).
Who is sponsoring clinical trial NCT01119950?
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 NCT01119950's enrollment target sits among peer trials
388 109th of 2000 higher than 1,892 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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