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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 evaluations

ECG 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

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: January 2004
Last updated: December 29, 2014

Page last updated: August 23, 2015

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