CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 211 enrolled
Drug / intervention
NVA237 +1 moredrug
Likely dose
NVA237 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/NCT01119937
NCT01119937Phase 3Completed
CompareCT.gov

A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Long Term Safety and Tolerability of NVA237 (50µg o.d.) Using Tiotropium (18µg o.d.) as an Active Control in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Novartis Pharmaceuticals·interventional·Posted May 10, 2010·Updated Jan 18, 2013

In Brief

A Phase 3 clinical trial evaluating NVA237 and Tiotropium for Chronic Obstructive Pulmonary Disease. Completed, enrolled 211 participants across 40 sites.

Detailed Summary

This is a 52-week, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily NVA237, using tiotropium as an active control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD) .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2010
Enrollment StartMay 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.1 years ago

Interventions

NVA237drug

50µg capsules for inhalation, delivered via a single dose dry powder inhaler (Concept 1®)

Tiotropiumdrug

18µg capsules for inhalation, delivered via HandiHaler®