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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01260636
First received: December 13, 2010
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Carotid, Aortic, Renal or Peripheral Artery Disease
 Drug: Gadobenate Dimeglumine
Drug: Gadopentetate Dimeglumine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Diagnostic Preference [ Time Frame: Immediately post dose ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Safety comparison of two diagnostic agents [ Time Frame: UP to 24 hours post dose of each contrast agent ] [ Designated as safety issue: No ]
    to compare the safety of the two investigational products in patients undergoing CE-MRA of the carotid, renal/abdominal and peripheral arteries


Enrollment: 120
Study Start Date: September 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Magnevist

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260636

Locations
China
Radiology Department Zhongshan Hospital, Fudan University
Shanghai, China
Sponsors and Collaborators
Bracco Diagnostics, Inc
  More Information

No publications provided

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01260636     History of Changes
Other Study ID Numbers: MH-137
Study First Received: December 13, 2010
Last Updated: January 4, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013