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Also known as Gadodiamide Injection
Gadodiamide · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Gadodiamide Injection | EXPERIMENTAL | All subjects received a single intravenous bolus injection via a power injector of Omniscan (Gadodiamide Injection) at a dose of 0.1 mmol/kg |
| Name | Type | Description |
|---|---|---|
| Gadodiamide Injection | DRUG | - |
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...
Gadodiamide is used in imaging studies to evaluate narrowing of the aorto-iliac arteries and the renal arteries. It is being studied in adults with aorto-iliac stenosis and renal artery stenosis, conditions in which blood vessels become narrowed. The studies enrolled adults 18 years and older in Germany.
Gadodiamide is developed by GE HealthCare Technologies Inc., which trades under the ticker GEHC. The company is the sponsor behind the clinical studies evaluating the agent in vascular imaging of the aorto-iliac and renal arteries.
Gadodiamide is in Phase 3 clinical development. It is investigational and has not been approved by the FDA for the studied indications. The Phase 3 studies evaluating its use in aorto-iliac stenosis and renal artery stenosis have been completed.
Gadodiamide has been evaluated in two completed Phase 3 trials. NCT00209443 studied narrowing of the aorto-iliac arteries and enrolled 407 participants. NCT00209391 studied narrowing of the renal arteries and enrolled 395 participants. Both trials were conducted in Germany in adults 18 years and older.
Yes, Gadodiamide Injection is another name for Gadodiamide. Both names refer to the same agent developed by GE HealthCare Technologies Inc. for evaluating narrowing of the aorto-iliac and renal arteries in Phase 3 studies.