Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Steno-occlusive Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Multihance

Intervention Type DRUG

0.5 Molar, single injection at 0.2 mL/kg

2

Group Type ACTIVE_COMPARATOR

vasovist

Intervention Type DRUG

0.25 molar single injection 0.03 ml/kg

Interventions

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Multihance

0.5 Molar, single injection at 0.2 mL/kg

Intervention Type DRUG

vasovist

0.25 molar single injection 0.03 ml/kg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No