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Gadodiamide

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment407
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00209443A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using GadodiamidePHASE3 COMPLETED 407 — — Sep 1, 2004Feb 28, 2006Apr 25, 20191 Germany
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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
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
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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 — 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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