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Generated: November 19, 2017

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR
ISOVUE-M 200

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Clinical Trial Listing

Trial ID Title Status Sponsor Phase Summary
NCT00209417 Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed TomographyTerminatedABX-CROPhase 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 TomographyTerminatedAverion International CorporationPhase 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 TomographyTerminatedCovancePhase 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 TomographyTerminatedExamination 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.
NCT00209417 Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed TomographyTerminatedQuintiles, 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.
NCT00209417 Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed TomographyTerminatedGE HealthcarePhase 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.
NCT00289029 A Study of Two Iodinated Contrast Agents in Renally Impaired Patients Undergoing Cardiac AngiographyCompletedBracco Diagnostics, IncPhase 4 The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with moderate to severe renal insufficiency undergoing cardiac angiography. Serum creatinine will be measured before and up to 48-72 hours after the administration of the contrast agent to evaluate renal function.
NCT00289614 Patients With Renal Impairment and Diabetes Undergoing Computed Tomography (CT)CompletedBracco Diagnostics, IncPhase 4 The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue (iopamidol) or Visipaque in diabetic patients with moderate to severe chronic renal impairment undergoing clinically indicated contrast enhanced multidetector computed tomography (MDCT). Serum creatinine will be measured before and up to 48-72 hours post dose.
NCT00292487 Patients With Renal Impairment Undergoing CTCompletedBracco Diagnostics, IncPhase 4 The purpose of the study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with mild to moderate renal impairment who undergo a clinically indicated IV contrast-enhanced (multidetector computed tomography) MDCT of the liver or MDCT angiography of the lower extremities. Serum Creatinine (SCr) will be measured before and up to 48-72 hours post dose.
NCT00351754 Detection of Pulmonary Embolism With CECTCompletedBracco Diagnostics, IncPhase 4 To compare the vascular enhancement of the two contrast agents in pulmonary Multi-detector CTA
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Conditions

Condition Name

Condition Name for ISOVUE-M 200
Intervention Trials
Diabetes Mellitus 2
Peripheral Arterial Occlusive Disease 2
Thoracic Aortic Aneurysm 1
Chronic Renal Impairment 1
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Condition MeSH

Condition MeSH for ISOVUE-M 200
Intervention Trials
Renal Insufficiency 3
Diabetes Mellitus 2
Renal Insufficiency, Chronic 2
Peripheral Arterial Disease 2
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Trial Locations

Trials by Country

Trials by Country for ISOVUE-M 200
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 200
Location Trials
New Jersey 9
Alabama 1
North Carolina 1
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Clinical Trial Progress

Clinical Trial Phase

Clinical Trial Phase for ISOVUE-M 200
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 200
Clinical Trial Phase Trials
Completed 12
Terminated 2
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Clinical Trial Sponsors

Sponsor Name

Sponsor Name for ISOVUE-M 200
Sponsor Trials
Bracco Diagnostics, Inc 9
GE Healthcare 2
Quintiles, Inc. 2
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Sponsor Type

Sponsor Type for ISOVUE-M 200
Sponsor Trials
Industry 16
Other 5
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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
QuintilesIMS
Chubb
Mallinckrodt
Fuji
Chinese Patent Office
Teva
Dow
Argus Health

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