CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 511 enrolled
Drug / intervention
NVA237 +2 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/NCT01697696
NCT01697696Phase 3Completed

A Multi-center, Randomized, Double-blind, 52-week Study to Assess the Safety of NVA237 Compared to QAB149 in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Have Moderate to Severe Airflow Limitation

Novartis Pharmaceuticals·interventional·Posted Oct 2, 2012·Updated Mar 16, 2016

In Brief

A Phase 3 clinical trial evaluating NVA237, Long-acting beta 2-agonist (LABA), and 1 other intervention for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 511 participants across 61 sites.

Detailed Summary

The purpose of the study is to provide long term safety data of NVA237. This study will assess the safety and tolerability of a single dose strength of NVA237.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2, 2012
Enrollment StartOct 1, 2012
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.8 years ago

Interventions

NVA237drug

NVA237 will be supplied in capsule form in blister packs for use in the Novartis Concept 1 SDDPI

Long-acting beta 2-agonist (LABA)drug

QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept 1 SDDPI

Placebodrug

Placebo to match QAB149