Cardiovascular Safety Study of Magnevist® Injection at Two Dose Levels and Two Injection Rates in Normal Subjects
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Gadopentetate dimeglumine (Magnevist, BAY86-4882) (Drug); Gadopentetate dimeglumine (Magnevist, BAY86-4882) (Drug); Gadopentetate dimeglumine (Magnevist, BAY86-4882) (Drug); Gadopentetate dimeglumine (Magnevist, BAY86-4882) (Drug); Moxifloxacin (BAY12-8039) (Drug); Placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Summary
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).
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Primary outcome: The primary study variable was heart-rate corrected QT (QTc) interval
Secondary outcome: Adverse event monitoring, laboratory evaluationsECG variables and overall interpretation
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Miami, Florida 33181-3405, United States
Additional Information
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Starting date: January 2004
Last updated: December 29, 2014
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