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Vasovist

Phase 3

Peripheral Vascular Diseases | Small molecule | Cardiovascular |Bayer AG|Trials 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

Vasovist clinical trials

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 contrast agent developed for magnetic resonance angiography (MRA) in patients with peripheral vascular diseases, including peripheral artery disease. It is intended to help visualize blood vessels during MRA imaging. It is not approved for commercial use and remains in clinical development.

Who is developing Vasovist?

Vasovist is being developed by Bayer AG, a multinational pharmaceutical and life sciences company. Bayer's shares trade on the OTC market in the United States under the ticker BAYRY. The drug is part of Bayer's cardiovascular imaging portfolio.

What phase is Vasovist in?

Vasovist is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently recruiting. The drug is investigational and has not been approved by the FDA or any regulatory agency for commercial use.

What clinical trials is Vasovist in?

Vasovist has been studied in one completed Phase 3 trial, NCT00296855, titled "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." The trial enrolled 261 patients across Argentina, Austria, Brazil, Germany, Mexico, and Switzerland.

Is Vasovist the same as BAY86-5283 or MS-325?

Yes, Vasovist is also known by the development codes BAY86-5283 and MS-325. These names refer to the same investigational contrast agent developed by Bayer AG for use in magnetic resonance angiography. The different codes reflect various stages of its development and licensing history.