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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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
Genders Eligible for Study:   Both
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
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

No publications provided by Novartis

Additional 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
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs processed this record on April 17, 2014