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NCT01712516 · 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, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,001
- Enrollment target
NCT01712516: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01712516 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,001 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01712516, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,001 participants
- Enrollment target
Study Summary
This study will assess the efficacy, safety and tolerability of indacaterol maleate/glycopyrronium bromide 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
Interventions
- DRUG Placebo
- DRUG NVA237
- DRUG QVA149
- DRUG QAB149
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,001 participants |
| Start Date | 2012-12 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
What the finished NCT01712516 record still lists
NCT01712516 is an interventional study that assigns participants to a tested intervention. Its 1,001 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 (30% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01712516 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01712516 about?
NCT01712516 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 indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.
What is the current status of trial NCT01712516?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,001 participants. The study started on 2012-12. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01712516?
The interventions under investigation include: Placebo (DRUG), NVA237 (DRUG), QVA149 (DRUG), QAB149 (DRUG).
Who is sponsoring clinical trial NCT01712516?
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 NCT01712516's enrollment target sits among peer trials
1,001 295th of 2000 higher than 1,705 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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