Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries (VALUE)

January 4, 2012 updated by: Bracco Diagnostics, Inc

A Phase III, Comparative Multi-center Randomized Double-blind, Crossover Study of the Safety, Tolerability and Diagnostic Efficacy of Gadobenate Dimeglumine and Gadopentetate Dimeglumine in Magnetic Resonance Angiography of the Carotid, Renal/Abdominal and Peripheral Arteries

To compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid, renal/abdominal and peripheral arteries

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Radiology Department Zhongshan Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 yrs of age or older
  • referred for enhanced MRA of carotid, renal/abdominal or peripheral arteries
  • Able to provide written informed consent and comply with protocol requirements
  • Highly suspected of or with known disease of the carotid, renal/abdominal or peripheral vasculature using specific criteria listed in the protocol

Exclusion Criteria:

  • pregnant or lactating females
  • Known allergy to one or more of the ingredients in the products under investigation
  • Significant congestive heart failure ( Class IV)
  • Moderate to severe chronic kidney disease
  • Therapeutic intervention of any kind for vascular disease in the territory of interest between the two contrast procedures
  • Vascular stents in vessels of interest
  • Received another contrast agent in the 24 hrs preceding or proceeding each exam
  • Previously entered into the study
  • Contraindications to MRI
  • Severe Claustrophobia Undergone DSA between the two exams

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MultiHance contrast agent
MultiHance administered at a dose of 0.1 mmol/kg (0.2 mL/kg)
Drug: Gadobenate Dimeglumine
0.1 mmol/kg, single dose
Other Names:
  • MultiHance
Active Comparator: Magnevist
Magnevist administered at a dose of 0.2 mmol/kg
Drug: Gadopentetate Dimeglumine
Double dose of 0.2 mmol/kg
Other Names:
  • Magnevist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Preference
Time Frame: Immediately post dose
Comparison of a single dose of MultiHance versus the double dose of Magnevist currently used for MR Angiography of the carotid, renal/abdominal/ and peripheral arteries in terms of global diagnostic perference
Immediately post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety comparison of two diagnostic agents
Time Frame: UP to 24 hours post dose of each contrast agent
to compare the safety of the two investigational products in patients undergoing CE-MRA of the carotid, renal/abdominal and peripheral arteries
UP to 24 hours post dose of each contrast agent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bracco Diagnostics, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 13, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (Estimate)

December 15, 2010

Study Record Updates

Last Update Posted (Estimate)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 4, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH-137

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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