Magnevist® Injection Enhanced MRA at Two Dose Levels Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Infrarenal Aorta and Peripheral Arteries - Tabular View

Tracking Information

First Received Date ^ICMJE

September 10, 2005

Last Updated Date

July 7, 2009

Start Date ^ICMJE

March 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant disease [ Time Frame: Image creation after injection - evaluation at blind read ]

Original Primary Outcome Measures ^ICMJE

Percentage change in Bone Mineral Density at the lumbar spine

Change History

Complete list of historical versions of study NCT00185276 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Diagnostic confidence [ Time Frame: At blinded or/and open label read of images ]
Visual assessment of stenosis [ Time Frame: At blinded or/and open label read of images ]
Difference in degree of stenosis [ Time Frame: At blinded or/and open label read of images ]
Other diagnostic findings [ Time Frame: At blinded or/and open label read of images ]
Image quality [ Time Frame: At blinded or/and open label read of images ]
Image evaluability and presence of artifacts [ Time Frame: At blinded or/and open label read of images ]
Ability to visualize arterial segments [ Time Frame: At blinded or/and open label read of images ]
Number of evaluable segments [ Time Frame: At blinded or/and open label read of images ]
Location and matching of stenosis [ Time Frame: At blinded or/and open label read of images ]
SI measurements [ Time Frame: At blinded or/and open label read of images ]
Patient management [ Time Frame: From baseline to 24 hours follow-up ]
Safety [ Time Frame: From baseline to 24 hours follow-up ]

Original Secondary Outcome Measures ^ICMJE

- Percentage change in Bone Mineral Density at the hip
- Percentage change in biochemical markers of bone turnover
- Proportion of patients with hot flushes
- Women's Health Questionnaire
- Proportion of patients with an abnormal endometrial biopsy
- Arthralgia questionnaire
- Pharmacogenetic analysis
- Digital breast density analysis

Descriptive Information

Brief Title ^ICMJE

Magnevist® Injection Enhanced MRA at Two Dose Levels Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Infrarenal Aorta and Peripheral Arteries

Official Title ^ICMJE

Randomized, Multi-Center Open Label Study of the Safety (Open-Label) and Efficacy (Open-Label & Blinded Reader) of Magnevist® Injection-Enhanced Magnetic Resonance Arteriography (MRA) at Two Dose Levels and 2-Dimensional-Time-of-Flight (2D-TOF) MRA in Patients Undergoing MRA of the Infrarenal Aorta and Peripheral Arteries With Intra-Arterial Digital Subtraction Arteriography (i.a. DSA) as Standard of Reference

Brief Summary

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the infrarenal aorta and peripheral arteries. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Peripheral Vascular Disease

Intervention ^ICMJE

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

369

Completion Date

August 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Has known or suspected peripheral vascular disease
Is scheduled for X-ray angiography

Exclusion Criteria:

Has any contraindication to magnetic resonance imaging
Is scheduled for any procedure before the X-ray angiography
Had previously had stents placed bilaterally in the region to be imaged

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00185276

Responsible Party

Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.

Study ID Numbers ^ICMJE

91208, 306781

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP