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Influence of Moxifloxacin on QTc Interval in Healthy Subjects for Positive Control Validation

This study has been completed.
Information provided by:
Bayer Identifier:
First received: November 12, 2009
Last updated: May 31, 2013
Last verified: May 2013

November 12, 2009
May 31, 2013
November 2009
June 2010   (Final data collection date for primary outcome measure)
QTc interval at 3 hours [ Time Frame: Day 1 of treatment period 1 and 2 ]
Same as current
Complete list of historical versions of study NCT01014247 on Archive Site
  • Safety variables [ Time Frame: Up to last visit of follow up ]
    Adverse events, clinical laboratory, vital signs, ECG findings
  • Pharmacokinetic parameters [ Time Frame: On different time points ]
    Cmax, Cmax,norm, tmax
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Influence of Moxifloxacin on QTc Interval in Healthy Subjects for Positive Control Validation
A Randomized, Double-blind, 2-way Crossover, Placebo-controlled Study to Investigate the Influence of a Single-dose of Moxifloxacin on the QTc Interval in Healthy Male and Female Subjects for Positive Control Validation in Selected Centers of the PATENT-1 Trial
The aim of this study is to investigate the effect of moxifloxacin on the QT interval in order to gain information on the validity of results that will be collected during another clinical study testing riociguat in patients with pulmonary arterial hypertension (PATENT-1 study).
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • QTc Evaluation
  • Electrocardiography
  • Drug: Avelox (Moxifloxacin, BAY12-8039)
    Single dose of 400 mg
  • Drug: Placebo
    Single dose of matching tablet
  • Active Comparator: Arm 1
    Intervention: Drug: Avelox (Moxifloxacin, BAY12-8039)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers
  • Age 18-75 years - Normal ECG Exclusion Criteria:
  • Abnormal ECG - Intolerance to fluorochinolones
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   Germany,   Singapore,   United Kingdom
2009-012363-34 ( EudraCT Number )
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Head Clinical Pharmacology, Bayer HealthCare Pharmaceuticals Inc.
Not Provided
Study Director: Bayer Study Director Bayer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP