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

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ClinicalTrials.gov Identifier: NCT01014247
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : June 3, 2013
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date  ICMJE November 12, 2009
First Posted Date  ICMJE November 16, 2009
Last Update Posted Date June 3, 2013
Study Start Date  ICMJE November 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2009)
QTc interval at 3 hours [ Time Frame: Day 1 of treatment period 1 and 2 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01014247 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Moxifloxacin on QTc Interval in Healthy Subjects for Positive Control Validation
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • QTc Evaluation
  • Electrocardiography
Intervention  ICMJE
  • Drug: Avelox (Moxifloxacin, BAY12-8039)
    Single dose of 400 mg
  • Drug: Placebo
    Single dose of matching tablet
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: Avelox (Moxifloxacin, BAY12-8039)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2013)
56
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2009)
60
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers
  • Age 18-75 years - Normal ECG Exclusion Criteria:
  • Abnormal ECG - Intolerance to fluorochinolones
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   Singapore,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01014247
Other Study ID Numbers  ICMJE 13796
2009-012363-34 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Head Clinical Pharmacology, Bayer HealthCare Pharmaceuticals Inc.
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date May 2013

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