Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
404 participants
INTERVENTIONAL
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Indacaterol 150 µg
Indacaterol 150 µg
Indacaterol 150 µg
Once daily (QD) via single-dose dry powder inhaler (SDDPI)
Indacaterol 300 µg
Indacaterol 300 µg
Indacaterol 300 µg
QD via SDDPI
Indacaterol 600 µg
Indacaterol 600 µg
Indacaterol 600 µg
QD via SDDPI
Placebo
Placebo
Placebo
QD via SDDPI
Placebo/moxifloxacin
Placebo/moxifloxacin
Placebo/moxifloxacin
Placebo QD via SDDPI for 14 days, followed by a single dose of moxifloxacin 400 mg
Interventions
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Indacaterol 150 µg
Once daily (QD) via single-dose dry powder inhaler (SDDPI)
Indacaterol 300 µg
QD via SDDPI
Indacaterol 600 µg
QD via SDDPI
Placebo
QD via SDDPI
Placebo/moxifloxacin
Placebo QD via SDDPI for 14 days, followed by a single dose of moxifloxacin 400 mg
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) 18.5-32 kg/m2
* Body weight at least 50 kg
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis investigative site
Miami, Florida, United States
Countries
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References
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Khindri S, Sabo R, Harris S, Woessner R, Jennings S, Drollmann AF. Cardiac safety of indacaterol in healthy subjects: a randomized, multidose, placebo- and positive-controlled, parallel-group thorough QT study. BMC Pulm Med. 2011 May 26;11:31. doi: 10.1186/1471-2466-11-31.
Other Identifiers
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CQAB149B2339
Identifier Type: -
Identifier Source: org_study_id