Status:
COMPLETED
Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Novartis
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief Summary
The study was designed to obtain data about the efficacy and safety of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese patients with chronic obstructive pulmonary disease (COPD) so that opti...
Eligibility Criteria
Inclusion
- Male and female Japanese aged 40 to 75 years old
- Moderate to severe chronic obstructive pulmonary disease (COPD) with smoking history of at least 20 pack years
Exclusion
- History of hospitalization for COPD exacerbation within past 6 months
- Use of long-term oxygen therapy
- History of asthma
- Respiratory tract infection within past 1 month
- Consistently very high or low blood sugar
- Clinically abnormal laboratory values or significant condition
- History of heart failure or heart attack within past 6 months
- History of long QT syndrome or long QT interval in electrocardiogram recorded at screening
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00403845
Start Date
December 1 2006
End Date
October 1 2007
Last Update
August 17 2011
Active Locations (8)
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1
Novartis Investigative site
Kasukabe, Japan
2
Novartis Investigator Site
Kishiwada, Japan
3
Novartis Investigative Site
Kurume, Japan
4
Novartis Investigative Site
Obihiro, Japan