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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00310596
First received: March 31, 2006
Last updated: February 2, 2010
Last verified: February 2010
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

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
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

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

No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer HealthCare Pharmaceutical Inc.
ClinicalTrials.gov Identifier: NCT00310596     History of Changes
Other Study ID Numbers: 91024, 305340
Study First Received: March 31, 2006
Last Updated: February 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
ECG safety

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
 Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013