Skip to main content
OpenTrials
Completed

NCT Number: NCT01263808

Cardiac Safety of Indacaterol

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis investigative site

Miami, Florida, 33126, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indacaterol 150 µg

Drug

Once daily (QD) via single-dose dry powder inhaler (SDDPI)

Indacaterol 300 µg

Drug

QD via SDDPI

Indacaterol 600 µg

Drug

QD via SDDPI

Placebo

Drug

QD via SDDPI

Placebo/moxifloxacin

Drug

Placebo QD via SDDPI for 14 days, followed by a single dose of moxifloxacin 400 mg

Primary outcomes

  1. Change from baseline in QTc interval (Fridericia's)

    Time frame: Change from baseline (prior to the first dose) to Day 14

Secondary outcomes

  1. Change from baseline in uncorrected QT interval

    Time frame: Change from baseline (prior to the first dose) to Day 14

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Multiple-dose, Placebo- and Positive-controlled Parallel Group Study to Evaluate the Effects of Indacaterol on Cardiac Safety in Healthy Subjects

Important dates

Study start
2008
Primary completion
2008
First posted
Dec 21, 2010
Registry last updated
Dec 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.