CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,324 enrolled
Drug / intervention
Glycopyrronium bromide +1 moredrug
Likely dose
Glycopyrronium bromide 50µgfrom 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/NCT01005901
NCT01005901Phase 3Completed

A 26-week Treatment, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

Novartis·interventional·Posted Nov 2, 2009·Updated Apr 12, 2012

In Brief

A Phase 3 clinical trial evaluating Glycopyrronium bromide and Placebo for Chronic Obstructive Pulmonary Disease. Completed, enrolled 1,324 participants across 96 sites in 11 countries.

Detailed Summary

A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, Japan, Netherlands, Romania, Russia, Singapore, South Korea, Spain, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2, 2009
Enrollment StartOct 1, 2009
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.7 years ago

Interventions

Glycopyrronium bromidedrug

Glycopyrronium bromide 50µg was supplied as inhalation capsules for use via a Single Dose Dry Powder Inhaler (SDDPI)

Placebodrug

Placebo inhalation capsules were provided for use via a SDDPI