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Cardiac Safety of Indacaterol

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01263808
First received: December 17, 2010
Last updated: December 20, 2010
Last verified: December 2010
History of Changes

December 17, 2010
December 20, 2010
April 2008
August 2008   (final data collection date for primary outcome measure)
Change from baseline in QTc interval (Fridericia's) [ Time Frame: Change from baseline (prior to the first dose) to Day 14 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01263808 on ClinicalTrials.gov Archive Site
Change from baseline in uncorrected QT interval [ Time Frame: Change from baseline (prior to the first dose) to Day 14 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Cardiac Safety of Indacaterol
A Randomized, Multiple-dose, Placebo- and Positive-controlled Parallel Group Study to Evaluate the Effects of Indacaterol on Cardiac Safety in Healthy Subjects

This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral moxifloxacin.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Healthy Volunteers
  • Chronic Obstructive Pulmonary Disease
  • 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: Placebo
    QD via SDDPI
  • Drug: Placebo/moxifloxacin
    Placebo QD via SDDPI for 14 days, followed by a single dose of moxifloxacin 400 mg
  • Experimental: Indacaterol 150 µg
    Indacaterol 150 µg
    Intervention: Drug: Indacaterol 150 µg
  • Experimental: Indacaterol 300 µg
    Indacaterol 300 µg
    Intervention: Drug: Indacaterol 300 µg
  • Experimental: Indacaterol 600 µg
    Indacaterol 600 µg
    Intervention: Drug: Indacaterol 600 µg
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Placebo/moxifloxacin
    Placebo/moxifloxacin
    Intervention: Drug: Placebo/moxifloxacin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
404
Not Provided
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy, non-smoking
  • Body mass index (BMI) 18.5-32 kg/m2
  • Body weight at least 50 kg

Exclusion Criteria:

  • 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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01263808
CQAB149B2339
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP