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Cardiac Safety of Indacaterol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01263808
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : December 21, 2010
Information provided by:

Brief Summary:
This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral moxifloxacin.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Chronic Obstructive Pulmonary Disease Drug: Indacaterol 150 µg Drug: Indacaterol 300 µg Drug: Indacaterol 600 µg Drug: Placebo Drug: Placebo/moxifloxacin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multiple-dose, Placebo- and Positive-controlled Parallel Group Study to Evaluate the Effects of Indacaterol on Cardiac Safety in Healthy Subjects
Study Start Date : April 2008
Actual Primary Completion Date : August 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Indacaterol 150 µg
Indacaterol 150 µg
Drug: Indacaterol 150 µg
Once daily (QD) via single-dose dry powder inhaler (SDDPI)

Experimental: Indacaterol 300 µg
Indacaterol 300 µg
Drug: Indacaterol 300 µg

Experimental: Indacaterol 600 µg
Indacaterol 600 µg
Drug: Indacaterol 600 µg

Placebo Comparator: Placebo
Drug: Placebo

Active Comparator: Placebo/moxifloxacin
Drug: Placebo/moxifloxacin
Placebo QD via SDDPI for 14 days, followed by a single dose of moxifloxacin 400 mg

Primary Outcome Measures :
  1. Change from baseline in QTc interval (Fridericia's) [ Time Frame: Change from baseline (prior to the first dose) to Day 14 ]

Secondary Outcome Measures :
  1. Change from baseline in uncorrected QT interval [ Time Frame: Change from baseline (prior to the first dose) to Day 14 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01263808

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United States, Florida
Novartis investigative site
Miami, Florida, United States, 33126
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT01263808    
Other Study ID Numbers: CQAB149B2339
First Posted: December 21, 2010    Key Record Dates
Last Update Posted: December 21, 2010
Last Verified: December 2010
Keywords provided by Novartis:
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents