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Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00415805
First Posted: December 25, 2006
Last Update Posted: March 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bracco Diagnostics, Inc
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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:


Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Sensitivity and specificity compared to DSA [ Time Frame: post dose ]

Secondary Outcome Measures:
  • accuracy and predictive values; inter-reader agreement for diagnostic performance [ Time Frame: post dose ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 22, 2006
First Posted: December 25, 2006
Last Update Posted: March 13, 2009
Last Verified: March 2009