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Generated: December 9, 2018

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CLINICAL TRIALS PROFILE FOR PROHANCE MULTIPACK

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Clinical Trials for Prohance Multipack

Trial ID Title Status Sponsor Phase Summary
NCT00522951 SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study Completed Bayer Phase 3 This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication.
NCT00709852 Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging Completed Bayer Phase 3 This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with ProHance.
NCT01019486 Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D) Completed University of Colorado, Denver Phase 4 Cardiovascular disease (CVD) remains the major cause of mortality and morbidity in both type 1 (T1D) and type 2 (T2D) diabetes patients; modifications of traditional CVD risk factors have had a limited impact. This project called Regadenoson Blood flow in Type 1 Diabetes (RABIT1D) and is proposed as a sub-study of the Coronary Artery Calcification in Type 1 Diabetes (CACTI) study, which has established a unique cohort of 656 T1D patients (age 20-55, minimal diabetes duration of 10 yrs) and 764 non-diabetic controls. This cohort is being followed for progression of coronary artery calcification (CAC) measured using the electron beam tomography (EBT) for development of clinical CVD. Participants have been well characterized during the baseline examination (4/00-3/02) and two follow-up re-examinations 3 and 6 years later. The study has provided important insights into the risk factors and possible prevention of premature CVD in T1D. We are proposing assess a subset of this population to determine vasodilatory reserve as it relates to early coronary atherosclerosis in T1D. Hypothesis: that myocardial blood imaging (MBF) reserve can be measured in Type 1 diabetes mellitus (DM) using regadenoson stress cardiac magnetic resonance and that significantly reduced MBF is a marker of extensive atherosclerotic disease correlated to coronary arterial calcification, plaque formation and impaired vasodilatory reserve.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Prohance Multipack

Condition Name

Condition Name for Prohance Multipack
Intervention Trials
Brain Metastases 1
Brain Disease 1
Type 1 Diabetes Mellitus 1
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Condition MeSH

Condition MeSH for Prohance Multipack
Intervention Trials
Nervous System Diseases 1
Brain Diseases 1
Central Nervous System Diseases 1
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Clinical Trial Locations for Prohance Multipack

Trials by Country

Trials by Country for Prohance Multipack
Location Trials
United States 22
Japan 16
Germany 11
Austria 4
Colombia 4
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Trials by US State

Trials by US State for Prohance Multipack
Location Trials
Ohio 2
Alabama 1
Rhode Island 1
South Carolina 1
Washington 1
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Clinical Trial Progress for Prohance Multipack

Clinical Trial Phase

Clinical Trial Phase for Prohance Multipack
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
N/A 2
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Clinical Trial Status

Clinical Trial Status for Prohance Multipack
Clinical Trial Phase Trials
Completed 4
Not yet recruiting 1
Recruiting 1
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Clinical Trial Sponsors for Prohance Multipack

Sponsor Name

Sponsor Name for Prohance Multipack
Sponsor Trials
Bayer 2
National Cancer Institute (NCI) 1
Bracco Diagnostics, Inc 1
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Sponsor Type

Sponsor Type for Prohance Multipack
Sponsor Trials
Other 3
Industry 3
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Baxter
Fuji
US Army
Accenture
US Department of Justice
Cipla
Medtronic
Express Scripts

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