CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 347 enrolled
Drug / intervention
Indacaterol 150 μg capsules +2 moredrug
Likely dose
Indacaterol 150 μg capsulesfrom 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/NCT00794157
NCT00794157Phase 3Completed
CompareCT.gov

A 12-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (150 and 300 µg Once Daily [od]) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Novartis Pharmaceuticals·interventional·Posted Nov 19, 2008·Updated Aug 17, 2011

In Brief

A Phase 3 clinical trial evaluating Indacaterol 150 μg capsules, Indacaterol 300 μg capsules, and 1 other intervention for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 347 participants across 60 sites in 6 countries.

Detailed Summary

This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily \[od\]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD)
CountriesHong Kong, India, Japan, Singapore, South Korea, Taiwan
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 19, 2008
Enrollment StartNov 1, 2008
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.6 years ago

Interventions

Indacaterol 150 μg capsulesdrug

Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Indacaterol 300 μg capsulesdrug

Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Placebo capsulesdrug

Placebo was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).