Trial Condition(s):

Healthy

Cardiovascular safety study of Magnevist® Injection at two dose levels and two injection rates in normal subjects

Bayer Identifier:

91024

ClinicalTrials.gov Identifier:

NCT00310596

EudraCT Number:

Not Available

Study Completed

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).

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

Trial Summary

Enrollment Goal
71
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

SFBC International

Miami, United States, 33181-3405

Status
Completed
 

Trial Design