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NCT02487446 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of QVA149 in COPD Patients
A Phase 3 study of Chronic Obstructive Pulmonary Disease, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 357
- Enrollment target
- 20
- Study locations
NCT02487446: Completed Phase 3 study of Chronic Obstructive Pulmonary Disease, sponsored by Novartis Pharmaceuticals.
NCT02487446 is a Phase 3 study of Chronic Obstructive Pulmonary Disease that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 357 participants, below the 1,750-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02487446, a Phase 3 study of Chronic Obstructive Pulmonary Disease, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 357 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG QVA149
- DRUG Umeclidinium/vilanterol
- DRUG Placebo (umeclidinium/vilanterol)
- DRUG Placebo (QVA149)
Study Locations (20)
Florida
- Novartis Investigative Site - Altamonte Springs
- Novartis Investigative Site - DeLand
- Novartis Investigative Site - Fort Lauderdale
- Novartis Investigative Site - Kissimmee
- Novartis Investigative Site - Miami
- Novartis Investigative Site - Pensacola
- Novartis Investigative Site - Pensacola
- Novartis Investigative Site - Port Orange
Alabama
- Novartis Investigative Site - Andalusia
- Novartis Investigative Site - Anniston
- Novartis Investigative Site - Jasper
- Novartis Investigative Site - Multiple Locations
Arizona
- Novartis Investigative Site - Multiple Locations
- Novartis Investigative Site - Tempe
- Novartis Investigative Site - Tucson
California
- Novartis Investigative Site - Huntington Beach
- Novartis Investigative Site - Rancho Mirage
Arkansas
- Novartis Investigative Site - Fayetteville
Colorado
- Novartis Investigative Site - Colorado Springs
Georgia
- Novartis Investigative Site - Conyers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 357 participants |
| Start Date | 2015-07-28 |
| Est. Completion | 2016-09-12 |
| Phase | Phase 3 |
What the finished NCT02487446 record still lists
NCT02487446 is an interventional study that assigns participants to a tested intervention. The registered 357 participants enrollment target is mid-sized for trials with a published cap, below the 1,750-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 4 interventions - of which QVA149 is the first listed.
NCT02487446 names 20 study sites across 7 states, led by Florida, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT02487446 about?
NCT02487446 is a clinical study titled "Efficacy and Safety Study of QVA149 in 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 NCT02487446?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 357 participants. The study started on 2015-07-28. Estimated completion is 2016-09-12.
What conditions does trial NCT02487446 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease.
What interventions are being tested in trial NCT02487446?
The interventions under investigation include: QVA149 (DRUG), Umeclidinium/vilanterol (DRUG), Placebo (umeclidinium/vilanterol) (DRUG), Placebo (QVA149) (DRUG).
Who is sponsoring clinical trial NCT02487446?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02487446 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02487446's enrollment target sits among peer trials
357 30th of 86 higher than 57 of 86 other Chronic Obstructive Pulmonary Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease 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.
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