drugset / Trial / NCT01005901

A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo

NCT01005901 ↗

Phase 3 Completed 1324 enrolled Novartis
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2009-10
Primary completion
2010-12
Completion
2010-12

Outcome

Met primary endpoint

paper Least squares mean (± standard error) trough FEV1 at Week 12 was significantly higher in patients receiving NVA237 (1.408 ± 0.0105 L), versus placebo PMID 22151296 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Glycopyrronium Unknown 50 ug Inhaled