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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
  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:


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
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: 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

Additional relevant MeSH terms:
Gadobenic acid
Gadolinium DTPA
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014