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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
  Purpose

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:

U.S. FDA Resources

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
QD via SDDPI
Experimental: Indacaterol 600 µg
Indacaterol 600 µg
 Drug: Indacaterol 600 µg
QD via SDDPI
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
QD via SDDPI
Active Comparator: Placebo/moxifloxacin
Placebo/moxifloxacin
 Drug: Placebo/moxifloxacin
Placebo QD via SDDPI for 14 days, followed by a single dose of moxifloxacin 400 mg

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01263808

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

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov 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:
Indacaterol
Moxifloxacin

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Moxifloxacin
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

ClinicalTrials.gov processed this record on May 21, 2013