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Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent

This study has been completed.
Sponsor:
Information provided by:
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00415805
First received: December 22, 2006
Last updated: March 12, 2009
Last verified: March 2009
History of Changes
  Purpose

This is an explorative small pilot study comparing two MRA contrast agents, one of which has been on the market for a few years and the other fairly new to the market. Since the study is explorative and designed to provide preliminary information for consideration for a future larger study, sample size is not based on statistical assumptions.


Condition Intervention Phase
Steno-Occlusive Disease
 Drug: Multihance
Drug: vasovist
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Pilot, Open-Label, Multicenter Intra-Individual Comparison of Multihance and Vasovist for Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) of Renal Arteries

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Sensitivity and specificity compared to DSA [ Time Frame: post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • accuracy and predictive values; inter-reader agreement for diagnostic performance [ Time Frame: post dose ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: December 2006
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Multihance
0.5 Molar, single injection at 0.2 mL/kg
Active Comparator: 2 Drug: vasovist
0.25 molar single injection 0.03 ml/kg

  Eligibility

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

Inclusion Criteria:

  • Known or suspected renovascular disease based on one of the following criteria:

    • severe hypertension
    • hypertension refractory to standard therapy
    • abrupt onset of moderate to severe hypertension at age < 35 years
    • normalized blood pressure by an ACE inhibitor in a patient with moderate or severe hypertension
    • unexplained by stable elevation of serum creatinine > 2Mg/dL
    • positive findings for stenosis from another imaging modality
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415805

Locations
Italy
Bracco Imaging, S.p.A
Milan, Italy, 20134
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Gianpaolo Pirovano, MD Bracco Diagnostics
  More Information

No publications provided

Responsible Party: Gianpaolo Pirovano, M.D. Executive Director, Corporate Medical Development, Bracco Diagnostics
ClinicalTrials.gov Identifier: NCT00415805     History of Changes
Other Study ID Numbers: MH 128
Study First Received: December 22, 2006
Last Updated: March 12, 2009
Health Authority: Czech Republic: State Institute for Drug Control

ClinicalTrials.gov processed this record on May 22, 2013