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Cardiac Safety of Indacaterol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01263808
First Posted: December 21, 2010
Last Update Posted: December 21, 2010
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.
Information provided by:
Novartis
  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: 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
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

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.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 17, 2010
First Posted: December 21, 2010
Last Update Posted: December 21, 2010
Last Verified: December 2010

Keywords provided by Novartis:
Indacaterol
Moxifloxacin

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