Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent - Full Text View

Sponsored by:	Bracco Diagnostics, Inc
Information provided by:	Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:	NCT00415805

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 III

Drug Information available for: Gadolinium dtpa Gadofosveset trisodium

U.S. FDA Resources

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

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:

Global diagnostic preference in the assessment of renal steno-occlusive disease [ Time Frame: post dose ] [ Designated as safety issue: No ]
Average quality of visualization [ Time Frame: post dose ] [ Designated as safety issue: No ]
Technical failure rate [ Time Frame: post dose ] [ Designated as safety issue: No ]
Sensitivity and specificity compared to DSA [ Time Frame: post dose ] [ Designated as safety issue: No ]
inter-reader agreement [ Time Frame: post dose ] [ Designated as safety issue: No ]

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
2: Active Comparator	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

Contacts

Contact: Massimo Dapra

39022177 ext 2393

massimo.dapra@bracco.com

Locations

Italy
Bracco Imaging, S.p.A	Recruiting
Milan, Italy, 20134

Sponsors and Collaborators

Bracco Diagnostics, Inc

Investigators

Study Director:

Gianpaolo Pirovano, MD

Bracco Diagnostics

More Information

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

ClinicalTrials.gov processed this record on January 16, 2009