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NCT02487498 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients.
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 355
- Enrollment target
NCT02487498: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT02487498 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 355 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02487498, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 355 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.
Primary Outcome
FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.
Interventions
- DRUG QVA149
- DRUG Umeclidinium/vilanterol
- DRUG Placebo (QVA149)
- DRUG Placebo (umeclidinium/vilanterol )
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 355 participants |
| Start Date | 2015-07-27 |
| Est. Completion | 2016-09-06 |
| Phase | Phase 3 |
What the finished NCT02487498 record still lists
NCT02487498 is an interventional study that assigns participants to a tested intervention. The registered 355 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 (54% lower).
The record links to 0 conditions, and to 4 interventions - of which QVA149 is the first listed.
NCT02487498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02487498 about?
NCT02487498 is a clinical study titled "Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients.". The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.
What is the current status of trial NCT02487498?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 355 participants. The study started on 2015-07-27. Estimated completion is 2016-09-06.
What interventions are being tested in trial NCT02487498?
The interventions under investigation include: QVA149 (DRUG), Umeclidinium/vilanterol (DRUG), Placebo (QVA149) (DRUG), Placebo (umeclidinium/vilanterol ) (DRUG).
Who is sponsoring clinical trial NCT02487498?
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 NCT02487498's enrollment target sits among peer trials
355 1025th of 2000 higher than 975 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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