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Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent

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ClinicalTrials.gov Identifier: NCT00415805
Recruitment Status : Completed
First Posted : December 25, 2006
Last Update Posted : March 13, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Steno-Occlusive Disease Drug: Multihance Drug: vasovist Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
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
Study Start Date : December 2006
Primary Completion Date : December 2008
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

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 Posted: December 25, 2006    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: March 2009