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Cardiovascular Safety Study of Magnevist® Injection at Two Dose Levels and Two Injection Rates in Normal Subjects

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00310596
First received: March 31, 2006
Last updated: February 2, 2010
Last verified: February 2010
History of Changes

March 31, 2006
February 2, 2010
February 2004
Not Provided
The primary study variable was heart-rate corrected QT (QTc) interval [ Time Frame: Within 15 min postinjection ]
The primary study variable was heart-rate corrected QT (QTc) interval.
Complete list of historical versions of study NCT00310596 on ClinicalTrials.gov Archive Site
  • Adverse event monitoring, laboratory evaluations [ Time Frame: 24 hrs postinjection ]
  • ECG variables and overall interpretation [ Time Frame: 24 hrs postinjection ]
Adverse event monitoring, laboratory evaluations, vital signs, and physical examination
Not Provided
Not Provided
 
Cardiovascular Safety Study of Magnevist® Injection at Two Dose Levels and Two Injection Rates in Normal Subjects
Cardiovascular Safety Study of 0.1 and 0.3 mmol/kg Magnevist® Injection at Two Injection Rates (Bolus and 10 mL/15 Sec.) in Normal Subjects Following a Randomized, Cross-over Design Using Placebo and a Concurrent Positive Control

The purpose of this study is to determine what effect Magnevist (gadopentetate dimeglumine) injection has on the way the heart conducts the electrical impulses that allow it to beat effectively. The study will compare Magnevist injection's effect to that of placebo (a saline injection).

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Healthy
  • Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
    0,1mmol/kg at 10 mL/15 sec
  • Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
    same dose as arm 1 at bolus rate (2mL/sec)
  • Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
    0,3mmol/kg at 10 mL/15 sec
  • Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
    same dose as arm 3 at bolus rate (2mL/sec)
  • Drug: Moxifloxacin (BAY12-8039)
    400 mg at 0,07 mL/sec over 60 min
  • Drug: Placebo
    0,9% saline at 0,6mL/kg at bolus rate
  • Experimental: Arm 1
    Intervention: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
  • Experimental: Arm 2
    Intervention: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
  • Experimental: Arm 3
    Intervention: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
  • Experimental: Arm 4
    Intervention: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
  • Active Comparator: Arm 5
    Intervention: Drug: Moxifloxacin (BAY12-8039)
  • Placebo Comparator: Arm 6
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
March 2004
Not Provided

Inclusion Criteria:

  • Subjects with an electrocardiogram [ECG] (normal sinus rhythm [SR], QTc > 450 msec) without clinically significant abnormalities
  • Non-smoker

Exclusion Criteria:

  • History of cardiovascular disease
  • Pregnant or nursing
  • Had any contraindication to moxifloxacin
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00310596
91024, 305340
Not Provided
Head Clinical Pharmacology, Bayer HealthCare Pharmaceutical Inc.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2010

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