Status:
COMPLETED
Cardiac Safety of Indacaterol
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Healthy Volunteers
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral moxifloxacin.
Eligibility Criteria
Inclusion
- Healthy, non-smoking
- Body mass index (BMI) 18.5-32 kg/m2
- Body weight at least 50 kg
Exclusion
- Recent/concurrent use of concomitant medications (except acetaminophen)
- Recent participation in other clinical trials
- Recent donation or loss of blood
- History/presence of a range of medical conditions, including electrocardiographic (ECG) abnormalities, diabetes mellitus, hyperthyroidism and impaired renal function
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT01263808
Start Date
April 1 2008
Last Update
December 21 2010
Active Locations (1)
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1
Novartis investigative site
Miami, Florida, United States, 33126