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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR ISOVUE-M 300

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Clinical Trials for Isovue-m 300

Trial ID Title Status Sponsor Phase Summary
NCT00209417 Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography Terminated ABX-CRO Phase 4 It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography Terminated Averion International Corporation Phase 4 It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography Terminated Covance Phase 4 It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography Terminated Examination Management Services Inc. Phase 4 It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Isovue-m 300

Condition Name

Condition Name for Isovue-m 300
Intervention Trials
Diabetes Mellitus 2
Peripheral Arterial Occlusive Disease 2
Pulmonary Embolism 1
Coronary Computed Tomographic Angiography 1
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Condition MeSH

Condition MeSH for Isovue-m 300
Intervention Trials
Renal Insufficiency 3
Arterial Occlusive Diseases 2
Kidney Diseases 2
Diabetes Mellitus 2
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Clinical Trial Locations for Isovue-m 300

Trials by Country

Trials by Country for Isovue-m 300
Location Trials
United States 11
United Kingdom 1
Canada 1
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Trials by US State

Trials by US State for Isovue-m 300
Location Trials
New Jersey 9
North Carolina 1
Alabama 1
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Clinical Trial Progress for Isovue-m 300

Clinical Trial Phase

Clinical Trial Phase for Isovue-m 300
Clinical Trial Phase Trials
Phase 4 10
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Isovue-m 300
Clinical Trial Phase Trials
Completed 12
Terminated 2
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Clinical Trial Sponsors for Isovue-m 300

Sponsor Name

Sponsor Name for Isovue-m 300
Sponsor Trials
Bracco Diagnostics, Inc 9
Duke University 2
GE Healthcare 2
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Sponsor Type

Sponsor Type for Isovue-m 300
Sponsor Trials
Industry 16
Other 5
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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Express Scripts
Chinese Patent Office
Queensland Health
Julphar
Healthtrust
Boehringer Ingelheim
UBS
Fuji

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