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Vasovist

Phase 3

Peripheral Vascular Diseases | Small molecule | Cardiovascular |Bayer AG|Last Updated: Apr 23, 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment261

FDA Designations

No designations recorded

Clinical trial landscape

Vasovist · 1 trial · 1 indication

Phase 3 1
NCT00296855Comparison Study of Vasovist® Magnetic Resonance Angiography (MRA) and an MRA With a Conventional Extracellular Contrast Agent With X-ray Angiography in Patients With Peripheral Artery DiseasePeripheral Vascular Diseases
COMPLETED261 Analytics
PHASE3COMPLETED
Comparison Study of Vasovist® Magnetic Resonance Angiography (MRA) and an MRA With a Conventional Extracellular Contrast Agent With X-ray Angiography in Patients With Peripheral Artery Disease
Peripheral Vascular DiseasesUnlock trial analytics

Study Endpoints

Primary Endpoints

Diagnostic potential of Vasovist enhanced MRA
Imaging after baseline visit, before and after Vasovist injection

Secondary Endpoints

Comparison of the quantitative assessment and the qualitative assessment of arterial stenosis/disease as compared to X-ray angiography
After imaging
Quantitative assessment of vessel enhancement
After imaging
Qualitative assessment of disease
After imaging
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
Vasovist (BAY86-5283, MS-325)DRUGAll patients receive a single IV bolus injection of Vasovist at a dose of 0,03 mmol/kg BW at a flowrate of 0,5 mL/sec, followed by a saline flush of at least 30 mL
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Patients with a certain circulation disorder (aortoiliac disease Fontaine-stage IIb / IV) and an indication for the evaluation of the peripheral run-off arteries from the infrarenal aorta to the calves * Patients who are scheduled for X-ray angiography and magnetic resonance a...

Countries:ArgentinaAustriaBrazilGermanyMexicoSwitzerland
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Frequently asked questions about Vasovist

What is Vasovist used for?

Vasovist is an investigational small molecule being developed for peripheral vascular diseases. It is a contrast agent studied for use in magnetic resonance angiography (MRA) to image peripheral artery disease. It is currently in Phase 3 clinical development and is not yet approved.

Who makes Vasovist?

Vasovist is being developed by Bayer AG, a company traded under the ticker BAYRY. The drug is currently in Phase 3 clinical trials for peripheral vascular diseases, specifically for use in magnetic resonance angiography.

What phase is Vasovist in?

Vasovist is in Phase 3 clinical development. It has completed one Phase 3 trial, which was an uncontrolled study of 261 patients with peripheral artery disease. The drug is investigational and has not been approved.

What clinical trials is Vasovist in?

Vasovist has one completed Phase 3 clinical trial, identified as NCT00296855. This study compared Vasovist magnetic resonance angiography (MRA) with an MRA using a conventional extracellular contrast agent, alongside X-ray angiography, in patients with peripheral artery disease.

How does Vasovist work?

Vasovist is a small molecule contrast agent used in magnetic resonance angiography (MRA). It is designed to enhance imaging of blood vessels in patients with peripheral artery disease, helping to visualize vascular structures during diagnostic procedures.