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Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00876694 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2011-11-08

Study results available
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Summary

This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe COPD. Data from this study will be used for the registration of indacaterol in Japan.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Indacaterol 300 µg

Indacaterol 300 µg once daily (od) via SDDPI

DRUG

Salmeterol 50 µg

Salmeterol 50 µg twice daily (bid) via Diskus®

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00876694 on ClinicalTrials.gov