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Gadodiamide

Phase 3

Aorto-iliac Stenosis | Small molecule | Cardiovascular |GE HealthCare Technologies Inc.|Last Updated: Apr 25, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment407

FDA Designations

No designations recorded

Clinical trial landscape

Gadodiamide · 2 trials · 3 indications

Phase 3 2
NCT00209443A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using GadodiamideAorto-iliac Stenosis
COMPLETED407 Analytics
NCT00209391A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using GadodiamideRenal Artery Stenosis
COMPLETED395 Analytics
PHASE3COMPLETED
A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using Gadodiamide
Aorto-iliac Stenosis
NCT00209443407
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PHASE3COMPLETED
A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide
Renal Artery Stenosis
NCT00209391395
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Study Endpoints

Primary Endpoints

Differences in subject level and vessel level sensitivity and specificity between CE-MRA and TOF-MRA in detecting stenosis,(>50% occlusion) in aorto-iliac arteries. IA-DSA is the truth standard.
27 hours
Subject level efficacy of CE-MRA in detecting stenosis (50% occlusion) of major renal arteries. IA-DSA is the truth standard.
72 hours

Secondary Endpoints

Differences in sensitivity, specificity, accuracy, PPV and NPV at subject and/or vessel level between CE-MRA and TOF-MRA in detecting stenosis (50% occlusion) in aorta-iliac arteries; Revascularisation strategies based on CE-MRA, TOF-MRA and IA DSA
27 hours
Subject and vessel level efficacy comparison of CE-MRA and TOF-MRA in detecting stenosis, accessing arteries and diagnosis; Efficacy of CE-MRA and TOF-MAR combined; Clinical utility; Safety
72 hours
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Gadodiamide InjectionEXPERIMENTALAll subjects received a single intravenous bolus injection via a power injector of Omniscan (Gadodiamide Injection) at a dose of 0.1 mmol/kg

Interventions

NameTypeDescription
Gadodiamide InjectionDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Study subjects must be adults with confirmed or suspected aorto-iliac stenosis. * The subject must have been referred for Digital Subtraction Angiography. Exclusion Criteria: * The subject has a known hypersensitivity to either conventional X-ray or gadolinium based MR contr...

Countries:Germany
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Frequently asked questions about Gadodiamide

What is Gadodiamide used for?

Gadodiamide is an investigational small molecule being studied for use in cardiovascular imaging. It is being evaluated for Renal Artery Stenosis and Aorto-iliac Stenosis, conditions involving the narrowing of arteries. The drug is in Phase 3 clinical development and is not yet approved by regulatory authorities.

Who makes Gadodiamide?

Gadodiamide is being developed by GE HealthCare Technologies Inc., which trades under the ticker GEHC. The company is conducting clinical trials to evaluate the safety and efficacy of Gadodiamide for imaging arterial narrowing in patients with Renal Artery Stenosis and Aorto-iliac Stenosis.

What phase is Gadodiamide in?

Gadodiamide is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies. The Phase 3 trials have been completed, and the drug is being studied for use in Renal Artery Stenosis and Aorto-iliac Stenosis.

What clinical trials is Gadodiamide in?

Gadodiamide has been studied in two completed Phase 3 clinical trials. NCT00209391 evaluated the drug for Renal Artery Stenosis with 395 participants, and NCT00209443 evaluated it for Aorto-iliac Stenosis and Arterial Occlusive Diseases with 407 participants. Both trials were conducted in Germany.

Is Gadodiamide the same as other contrast agents?

Gadodiamide is a gadolinium-based contrast agent used in magnetic resonance imaging. It is being studied specifically for evaluating arterial narrowing in Renal Artery Stenosis and Aorto-iliac Stenosis. The drug is distinct from other agents due to its specific formulation and intended use in these cardiovascular conditions.