At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 83 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.
A Randomized, Double-blind, Placebo-controlled, 4 Period Incomplete Block Cross-over, Multi-center, Multiple Dose (7 Days) Dose-ranging Study to Assess the Efficacy and Safety of 4 Doses of NVA237 in Patients With Stable COPD, Compared to Seven Days Treatment With Tiotropium (18μg Once Daily, Open Label) as an Active Control
In Brief
A Phase 2 clinical trial evaluating NVA237, Placebo, and 1 other intervention for Chronic Obstructive Pulmonary Disease. Completed, enrolled 83 participants across 3 sites in 3 countries.
Detailed Summary
This study will assess the efficacy and safety of glycopyrronium bromide (NVA237) in patients with stable COPD, in comparison to an active comparator.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesBelgium, France, Japan
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2007
First PostedJul 2007
Primary CompletionDec 2007
TodayJul 2026
First PostedJul 16, 2007
Enrollment StartJul 1, 2007
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 19.0 years ago
Interventions
NVA237drug
single-dose dry-powder inhaler (SDDPI)
Placebodrug
single-dose dry-powder inhaler (SDDPI)
Tiotropiumdrug
Handihaler inhaler