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Cardiac Safety of Indacaterol

This study has been completed.
Information provided by:
Novartis Identifier:
First received: December 17, 2010
Last updated: December 20, 2010
Last verified: December 2010
This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral moxifloxacin.

Condition Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

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

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

Enrollment: 404
Study Start Date: April 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01263808

United States, Florida
Novartis investigative site
Miami, Florida, United States, 33126
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT01263808     History of Changes
Other Study ID Numbers: CQAB149B2339
Study First Received: December 17, 2010
Last Updated: December 20, 2010

Keywords provided by Novartis:

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors processed this record on September 21, 2017