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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Bracco Diagnostics, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Contrast Media
Gadolinium DTPA
Gadobenic acid
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014