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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00310596
Recruitment Status : Completed
First Posted : April 4, 2006
Last Update Posted : December 30, 2014
Information provided by (Responsible Party):

Brief 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).

Condition or disease Intervention/treatment Phase
Healthy Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882) Drug: Moxifloxacin (BAY12-8039) Drug: Placebo Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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 Start Date : January 2004
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
0,1mmol/kg at 10 mL/15 sec
Experimental: Arm 2 Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
same dose as arm 1 at bolus rate (2mL/sec)
Experimental: Arm 3 Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
0,3mmol/kg at 10 mL/15 sec
Experimental: Arm 4 Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
same dose as arm 3 at bolus rate (2mL/sec)
Active Comparator: Arm 5 Drug: Moxifloxacin (BAY12-8039)
400 mg at 0,07 mL/sec over 60 min
Placebo Comparator: Arm 6 Drug: Placebo
0,9% saline at 0,6mL/kg at bolus rate

Primary Outcome Measures :
  1. The primary study variable was heart-rate corrected QT (QTc) interval [ Time Frame: Within 15 min postinjection ]

Secondary Outcome Measures :
  1. Adverse event monitoring, laboratory evaluations [ Time Frame: 24 hrs postinjection ]
  2. ECG variables and overall interpretation [ Time Frame: 24 hrs postinjection ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310596

United States, Florida
Miami, Florida, United States, 33181-3405
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00310596     History of Changes
Other Study ID Numbers: 91024
First Posted: April 4, 2006    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by Bayer:
ECG safety

Additional relevant MeSH terms:
Norgestimate, ethinyl estradiol drug combination
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Anti-Infective Agents
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Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs