Efficacy and Safety Study to Evaluate Gadovist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00395733

Purpose

The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.

Condition	Intervention	Phase
Vascular Diseases	Drug: Gadovist / Magnevist Drug: Magnevist / Gadovist	Phase III

MedlinePlus related topics: MRI Scans Vascular Diseases

Drug Information available for: Gadolinium DTPA

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Single-Blind, Intra-Individual, Crossover, Multicenter Study of the Efficacy, Safety and Tolerability of Gadovist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent in the Enhanced MR Angiography in Chinese Patients

Further study details as provided by Bayer:

Primary Outcome Measures:

Number of vessel segments visualized with diagnostic quality [ Time Frame: Postcontrast ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in diagnostic confidence in the assessment of vessel diseases [ Time Frame: Precontrast and postcontrast MRI ] [ Designated as safety issue: No ]

Enrollment:	83
Study Start Date:	October 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: Gadovist / Magnevist Gadovist (1.0 M, at a dose of 0.2 ml/kg BW, up to 0.3 ml/kg BW if 3 FOVs to be imaged) with Magnevist (0.5 M, at a dose of 0.4 ml/kg BW, up to 0.6 ml/kg BW if 3 FOVs to be imaged) at an interval of 48 hours
Arm 2: Active Comparator	Drug: Magnevist / Gadovist Magnevist (0.5 M, at a dose of 0.4 ml/kg BW, up to 0.6 ml/kg BW if 3 FOVs to be imaged) with Gadovist (1.0 M, at a dose of 0.2 ml/kg BW, up to 0.3 ml/kg BW if 3 FOVs to be imaged) at an interval of 48 hours.

Detailed Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chinese origin
Known or suspected blood vessel diseases

Exclusion Criteria:

Pregnancy
Lactation
Conditions interfering with MRI
Allergy to any contrast agent or any drugs
Participation in other trial
Require emergency treatment
Severely impaired liver and kidney functions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395733

Locations

China

Shanghai, China, 200025

Beijing, China, 100853
China, Sichuan

Chengdu, Sichuan, China, 610041

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Healthcare Company Ltd. ( Therapeutic Area Head )
Study ID Numbers:	91537, 309762
Study First Received:	November 2, 2006
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00395733 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Bayer:

Gadovist
MRI Imaging
vascular diseases
Chinese

Study placed in the following topic categories:

Vascular Diseases

Additional relevant MeSH terms:

Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009