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Sponsored by: |
Bracco Diagnostics, Inc |
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Information provided by: | Bracco Diagnostics, Inc |
ClinicalTrials.gov Identifier: | NCT00415805 |
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 III |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 35 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Multihance
0.5 Molar, single injection at 0.2 mL/kg
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2: Active Comparator |
Drug: vasovist
0.25 molar single injection 0.03 ml/kg
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Known or suspected renovascular disease based on one of the following criteria:
Contact: Massimo Dapra | 39022177 ext 2393 | massimo.dapra@bracco.com |
Italy | |
Bracco Imaging, S.p.A | Recruiting |
Milan, Italy, 20134 |
Study Director: | Gianpaolo Pirovano, MD | Bracco Diagnostics |
Responsible Party: | Bracco Diagnostics ( Gianpaolo Pirovano, M.D. Executive Director, Corporate Medical Development ) |
Study ID Numbers: | MH 128 |
Study First Received: | December 22, 2006 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00415805 |
Health Authority: | Czech Republic: State Institute for Drug Control |