Status:
COMPLETED
Dose Ranging Study for Indacaterol in Japanese Asthma Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study was designed to provide data about the safety and efficacy of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese asthma patients so that an optimal dose, or doses, could be chosen fo...
Eligibility Criteria
Inclusion
- Male and female Japanese asthmatic patients aged 18 to 75 years old.
Exclusion
- Patients who have been hospitalized or had emergency room treatment for an acute asthma attack in the 6 months prior to the first day of screening or during the screening period.
- Patients who have used tobacco products within 6 months prior to the first day of screening or have a smoking history of greater than 10 pack years.
- Patients with a history of malignancy with the exception of localized basal cell carcinoma of the skin.
- Pregnant or nursing (lactating) women.
- Patients who have had treatment with disallowed medications including investigational drug.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00403754
Start Date
November 1 2006
End Date
November 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
Shimotsuga, Japan
4
Novartis Investigator Site
Suita, Japan