check_circleStudy Completed

Healthy

Bayer Identifier:

91024

ClinicalTrials.gov Identifier:

NCT00310596

EudraCT Number:

Not Available

EU CT Number:

Not Available
Cardiovascular safety study of Magnevist® Injection at two dose levels and two injection rates in normal subjects

Trial purpose

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).

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Subjects with an electrocardiogram [ECG] (normal sinus rhythm [SR], QTc > 450 msec) without clinically significant abnormalities
    - Non-smoker
  • - History of cardiovascular disease- Pregnant or nursing- Had any contraindication to moxifloxacin

Trial summary

Enrollment Goal
71
Trial Dates
January 2004 - March 2004
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
SFBC InternationalMiami, 33181-3405, United States

Primary Outcome

  • The primary study variable was heart-rate corrected QT (QTc) interval
    date_rangeTime Frame:
    Within 15 min postinjection
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Adverse event monitoring, laboratory evaluations
    date_rangeTime Frame:
    24 hrs postinjection
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    Safety Issue:
    None
  • ECG variables and overall interpretation
    date_rangeTime Frame:
    24 hrs postinjection
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    Safety Issue:
    None

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Randomized
Blinding
Double Blind
Assignment
Crossover Assignment
Trial Arms
6

Additional Information

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