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

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00310596

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).

Condition	Intervention	Phase
Healthy	Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882) Drug: Moxifloxacin (BAY12-8039) Drug: Placebo	Phase I

Drug Information available for: Gadolinium DTPA Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Crossover Assignment, Safety Study
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

Further study details as provided by Bayer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Adverse event monitoring, laboratory evaluations [ Time Frame: 24 hrs postinjection ]
ECG variables and overall interpretation [ Time Frame: 24 hrs postinjection ]

Enrollment:	70
Study Start Date:	February 2004
Study Completion Date:	March 2004

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310596

Locations

United States, Florida

Miami, Florida, United States, 33181-3405

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

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

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No publications provided

Responsible Party:	Bayer HealthCare Pharmaceutical Inc. ( Head Clinical Pharmacology )
Study ID Numbers:	91024, 305340
Study First Received:	March 31, 2006
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00310596 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

ECG safety

Study placed in the following topic categories:

Moxifloxacin
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Moxifloxacin
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009