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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR COLESTIPOL HYDROCHLORIDE

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Clinical Trials for Colestipol Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00000512 Familial Atherosclerosis Treatment Study Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 To compare the effects of two intensive lipid-lowering regimens with conventional therapy on coronary atherosclerosis as assessed by arteriography.
NCT00000512 Familial Atherosclerosis Treatment Study Completed University of Washington Phase 3 To compare the effects of two intensive lipid-lowering regimens with conventional therapy on coronary atherosclerosis as assessed by arteriography.
NCT00000599 Cholesterol-Lowering Atherosclerosis Study (CLAS) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 To determine whether combined therapy with the lipid lowering agents colestipol hydrochloride plus niacin would produce significant change in coronary, carotid, and femoral artery atherosclerosis and coronary bypass graft lesions as determined by angiography. Also, to determine possible correlations between lesion changes and plasma lipid and lipoprotein cholesterol levels and to explore interrelationships of atherosclerosis change in femoral, coronary, and carotid arteries.
NCT00116870 MARS - Monitored Atherosclerosis Regression Study Completed Merck Sharp & Dohme Corp. Phase 2/Phase 3 The purpose of this study is to determine whether significant alterations in serum lipoproteins as provided by the drug lovastatin can substantially reduce atherosclerosis progression or even induce regression.
NCT00203476 A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction Completed American Society of Health-System Pharmacists Research and Education Foundation Phase 4 To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) guidelines for low density lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis. High-density lipoproteins (HDL) elevations are monitored between the three groups to determine efficacy as a secondary outcome.
NCT00203476 A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction Completed Tuscaloosa Research & Education Advancement Corporation Phase 4 To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) guidelines for low density lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis. High-density lipoproteins (HDL) elevations are monitored between the three groups to determine efficacy as a secondary outcome.
NCT00307307 Carotid Atherosclerosis Regression at Magnetic Resonance Assessment. Completed Kos Pharmaceuticals Phase 4 The primary objective of this randomized, double blind, placebo controlled pilot study is to determine if therapies aimed at lowering LDL cholesterol (HMGCoA reductase inhibitor – simvastatin) or increasing HDL cholesterol (Niaspan) will induce regression of carotid atherosclerotic plaque in vivo using MRI imaging techniques. MR plaque morphology at baseline will be compared to that after 6 and 12 months of therapy and changes in MR characteristics will be compared to changes in lipoprotein parameters and urinary isoprostanes. The effect of moderate LDL reduction, aggressive LDL reduction and the combination of aggressive LDL reduction and HDL elevation on MRI plaque characteristics will be compared by randomly assigning subjects (n=69) with carotid disease (>30% stenosis by ultrasound criteria) to one of three treatment arms; 1. Simvastatin 20 mg daily and placebo Niaspan (n=23) 2. Simvastatin 80 mg daily and placebo Niaspan (n=23) 3. Simvastatin 20 mg daily and active Niaspan (n=23) Treatment group 2 and 3 will have roughly equivalent LDL lowering because of the synergistic LDL lowering effect of the combination of simvastatin and Niaspan.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Colestipol Hydrochloride

Condition Name

Condition Name for Colestipol Hydrochloride
Intervention Trials
Myocardial Ischemia 2
Cardiovascular Diseases 2
Coronary Disease 2
Atherosclerosis 2
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Condition MeSH

Condition MeSH for Colestipol Hydrochloride
Intervention Trials
Atherosclerosis 4
Coronary Artery Disease 3
Myocardial Ischemia 3
Coronary Disease 3
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Clinical Trial Locations for Colestipol Hydrochloride

Trials by Country

Trials by Country for Colestipol Hydrochloride
Location Trials
United States 5
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Trials by US State

Trials by US State for Colestipol Hydrochloride
Location Trials
Florida 1
Massachusetts 1
Missouri 1
Alabama 1
California 1
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Clinical Trial Progress for Colestipol Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Colestipol Hydrochloride
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Colestipol Hydrochloride
Clinical Trial Phase Trials
Completed 7
Terminated 1
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Clinical Trial Sponsors for Colestipol Hydrochloride

Sponsor Name

Sponsor Name for Colestipol Hydrochloride
Sponsor Trials
Merck Sharp & Dohme Corp. 2
National Heart, Lung, and Blood Institute (NHLBI) 2
American Society of Health-System Pharmacists Research and Education Foundation 1
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Sponsor Type

Sponsor Type for Colestipol Hydrochloride
Sponsor Trials
Other 10
Industry 4
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
US Army
Covington
Fish and Richardson
Argus Health
Boehringer Ingelheim
UBS
Farmers Insurance
Mallinckrodt

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