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NCT01202188 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,144
- Enrollment target
NCT01202188: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01202188 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 2,144 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (178% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01202188, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,144 participants
- Enrollment target
Study Summary
The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.
Primary Outcome
Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No
Interventions
- DRUG placebo
- DRUG tiotropium
- DRUG indacaterol and glycopyrronium (QVA149)
- DRUG glycopyrronium (NVA237)
- DRUG indacaterol (QAB149)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,144 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
What the finished NCT01202188 record still lists
NCT01202188 is an interventional study that assigns participants to a tested intervention. Its 2,144 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 (178% higher).
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT01202188 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01202188 about?
NCT01202188 is a clinical study titled "A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)". The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.
What is the current status of trial NCT01202188?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,144 participants. The study started on 2010-09. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01202188?
The interventions under investigation include: placebo (DRUG), tiotropium (DRUG), indacaterol and glycopyrronium (QVA149) (DRUG), glycopyrronium (NVA237) (DRUG), indacaterol (QAB149) (DRUG).
Who is sponsoring clinical trial NCT01202188?
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 NCT01202188's enrollment target sits among peer trials
2,144 96th of 2000 higher than 1,905 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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