Cardiac Safety of Indacaterol
NCT01263808 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 404
Last updated 2010-12-21
Summary
This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral moxifloxacin.
Conditions
- Healthy Volunteers
- Chronic Obstructive Pulmonary Disease
Interventions
- DRUG
-
Indacaterol 150 µg
Once daily (QD) via single-dose dry powder inhaler (SDDPI)
- DRUG
-
Indacaterol 300 µg
QD via SDDPI
- DRUG
-
Indacaterol 600 µg
QD via SDDPI
- DRUG
-
QD via SDDPI
- DRUG
-
Placebo/moxifloxacin
Placebo QD via SDDPI for 14 days, followed by a single dose of moxifloxacin 400 mg
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2008-08-31
Countries
- United States
Study Locations
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