CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,001 enrolled
Drug / intervention
QVA149 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01712516
NCT01712516Phase 3Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Oct 23, 2012·Updated Jul 15, 2015

In Brief

A Phase 3 clinical trial evaluating QVA149, QAB149, and 2 other interventions for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 1,001 participants across 95 sites in 9 countries.

Detailed Summary

This study will assess the efficacy, safety and tolerability of indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD)
CountriesColombia, Egypt, France, Guatemala, Hungary, Panama, Slovakia, Slovenia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 23, 2012
Enrollment StartDec 1, 2012
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.7 years ago

Interventions

QVA149drug

QVA149 was supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI

QAB149drug

QAB149 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.

NVA237drug

NVA237 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.

Placebodrug

Placebo was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.