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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations SFBC International Miami, United States, 33181-3405 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- The primary study variable was heart-rate corrected QT (QTc) intervalTimeframe: Within 15 min postinjection
Secondary Outcome
- Adverse event monitoring, laboratory evaluationsTimeframe: 24 hrs postinjection
- ECG variables and overall interpretationTimeframe: 24 hrs postinjection
Additional Information
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