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NCT01727141 · ClinicalTrials.gov registry record · Phase 3
A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.
A Phase 3 study of Chronic Obstructive Pulmonary Disease (COPD), sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,042
- Enrollment target
- 20
- Study locations
NCT01727141: Completed Phase 3 study of Chronic Obstructive Pulmonary Disease (COPD), sponsored by Novartis Pharmaceuticals.
NCT01727141 is a Phase 3 study of Chronic Obstructive Pulmonary Disease (COPD) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,042 participants, above the 622-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (68% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01727141, a Phase 3 study of Chronic Obstructive Pulmonary Disease (COPD), has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,042 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.
Primary Outcome
Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 \* visit interaction, and visit, treatment \* visit int
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NVA237
- DRUG QVA149
- DRUG QAB149
Study Locations (20)
California
- Novartis Investigative Site - Fountain Valley
- Novartis Investigative Site - Fullerton
- Novartis Investigative Site - Huntington Beach
- Novartis Investigative Site - Montclair
- Novartis Investigative Site - Orange
- Novartis Investigative Site - Orangevale
- Novartis Investigative Site - Paramount
- Novartis Investigative Site - Riverside
- Novartis Investigative Site - Roseville
- Novartis Investigative Site - Sacramento
- Novartis Investigative Site - Sacramento
- Novartis Investigative Site - Sacramento
- Novartis Investigative Site - San Diego
- Novartis Investigative Site - Torrance
Alabama
- Novartis Investigative Site - Birmingham
- Novartis Investigative Site - Montgomery
Arizona
- Novartis Investigative Site - Mesa
- Novartis Investigative Site - Phoenix
Colorado
- Novartis Investigative Site - Wheat Ridge
Connecticut
- Novartis Investigative Site - Waterbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,042 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
What the finished NCT01727141 record still lists
NCT01727141 is an interventional study that assigns participants to a tested intervention. Its 1,042 participants enrollment target places it among the larger protocols in the corpus, above the 622-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (68% higher).
The record links to 1 condition, with Chronic Obstructive Pulmonary Disease (COPD) appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01727141 names 20 study sites across 5 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT01727141 about?
NCT01727141 is a clinical study titled "A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.". This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.
What is the current status of trial NCT01727141?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,042 participants. The study started on 2012-11. Estimated completion is 2014-02.
What conditions does trial NCT01727141 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease (COPD).
What interventions are being tested in trial NCT01727141?
The interventions under investigation include: Placebo (DRUG), NVA237 (DRUG), QVA149 (DRUG), QAB149 (DRUG).
Who is sponsoring clinical trial NCT01727141?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01727141 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Obstructive Pulmonary Disease (COPD)
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 NCT01727141's enrollment target sits among peer trials
1,042 12th of 36 higher than 25 of 36 other Chronic Obstructive Pulmonary Disease (COPD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease (COPD) 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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