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OpenTrials
Completed

NCT Number: NCT00310596

Cardiovascular Safety Study of Magnevist® Injection at Two Dose Levels and Two Injection Rates in Normal Subjects

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).

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Miami, Florida, 33181-3405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug

0,1mmol/kg at 10 mL/15 sec

Moxifloxacin (BAY12-8039)

Drug

400 mg at 0,07 mL/sec over 60 min

Placebo

Drug

0,9% saline at 0,6mL/kg at bolus rate

Primary outcomes

  1. The primary study variable was heart-rate corrected QT (QTc) interval

    Time frame: Within 15 min postinjection

Secondary outcomes

  1. Adverse event monitoring, laboratory evaluations

    Time frame: 24 hrs postinjection

  2. ECG variables and overall interpretation

    Time frame: 24 hrs postinjection

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2004
First posted
Apr 4, 2006
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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