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Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease

NCT01026389 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2012-12-11

Study results available
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Summary

This study is an efficacy evaluation of Dotarem®-enhanced magnetic resonance angiography (MRA) compared to Gadovist®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.

Conditions

  • Peripheral Arterial Disease

Interventions

DRUG

Dotarem

DOTAREM, 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus

DRUG

Gadovist

Gadovist, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus

Sponsors & Collaborators

  • Guerbet

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-06-30
Completion
2012-01-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01026389 on ClinicalTrials.gov