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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR CHOLESTYRAMINE

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Clinical Trials for Cholestyramine

Trial ID Title Status Sponsor Phase Summary
NCT00000461 Harvard Atherosclerosis Reversibility Project (HARP) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 To determine by sequential coronary arteriography whether a lipid-lowering diet with and without lipid-lowering drugs could reverse coronary artery disease in normocholesterolemic patients. Also, to test whether fish oil supplements could improve human coronary atherosclerosis. Finally, to determine the effect of combination therapy with lipid-reducing drugs in patients with coronary heart disease and "normal" cholesterol levels. At least three clinical trials were conducted.
NCT00000463 Post Coronary Artery Bypass Graft (CABG) Study Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 To determine the relative effectiveness of moderate versus more aggressive lipid lowering, and of low dose anticoagulation versus placebo, in delaying saphenous vein coronary bypass graft atherosclerosis and preventing occlusion of saphenous grafts of patients with saphenous vein coronary bypass grafts placed 1 to 11 years previously.
NCT00000488 Lipid Research Clinics Coronary Primary Prevention Trial (CPPT) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 To determine whether reduction of cholesterol by drug therapy significantly lowered the atherosclerotic coronary heart disease rate in a group of hypercholesterolemic but otherwise healthy men. Total dollars spent on the CPPT from June 1973 were $142,250,000. We do not have a year-by-year breakdown.
NCT00000594 NHLBI Type II Coronary Intervention Study Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 To determine whether lowering of cholesterol with cholestyramine in a population with Type II hyperlipidemia led to a decreased rate of progression (a regression of coronary artery disease) as demonstrated by death, myocardial infarction, or progression of disease on angiography.
NCT00004266 Study of Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes at High Risk of Kidney or Heart Disease Completed Hennepin County Medical Center, Minneapolis N/A OBJECTIVES: I. Establish a long-term working relationship between clinical investigators and the Minnesota American Indian community. II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria. III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol Education Program in preventing nephropathy and vascular diseases in these patients.
NCT00004266 Study of Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes at High Risk of Kidney or Heart Disease Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) N/A OBJECTIVES: I. Establish a long-term working relationship between clinical investigators and the Minnesota American Indian community. II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria. III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol Education Program in preventing nephropathy and vascular diseases in these patients.
NCT00101374 Effect of Leflunomide on T Cell Proliferation in HIV-Infected Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 This study will evaluate the effect of leflunomide on the life cycle of a specific immune cell called CD4+ T cell in HIV-infected patients. Leflunomide is approved by the Food and Drug Administration for treating rheumatoid arthritis. It works by blocking cell division in activated T cells. In HIV infection, the HIV virus causes increased activation of T cells. The activated cells become infected and die. Activation may also cause the death of T cells that are not infected with HIV. T cells are necessary for the body to fight infections and cancer. This study will see if leflunomide can block T-cell division and possibly reduce the number of cells that die, reduce the number of cells in which HIV can reproduce, and lead to a lower level of HIV virus in the body. HIV-infected patients between 18 and 65 years of age who have 1) HIV viral levels of 1,000 copies/mL or more, 2) a CD4+ T-cell count of 350 cells/mm3 or more, and 3) a CD4+ T-cell count that has never been less than 200 cells/mm3 may be eligible for this study. Candidates are screened with a medical history, physical examination, blood and urine tests, chest x-ray, and electrocardiogram (EKG). Participants are randomly assigned to take leflunomide or placebo (a substance with no active ingredient) every day for 28 days. They come to the clinic three times during the first 29 days of the study (days 1, 15, and 29) for a physical examination and review of any drug side effects. Patients taking placebo end their participation on day 29. Patients taking leflunomide stop taking the drug on day 29 and begin taking cholestyramine three times a day for 11 days out of the next 14 days to clear the leflunomide from their body. On day 43, they return to the clinic to have their leflunomide level checked to make sure that only very little or none of the drug remains in the body. If the level is low, patients end their participation on or around day 57. If the level remains high, they repeat the cholestyramine treatment.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Cholestyramine

Condition Name

Condition Name for Cholestyramine
Intervention Trials
Cardiovascular Diseases 4
Myocardial Ischemia 4
Coronary Disease 4
Heart Diseases 4
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Condition MeSH

Condition MeSH for Cholestyramine
Intervention Trials
Coronary Disease 4
Coronary Artery Disease 4
Cardiovascular Diseases 4
Hypercholesterolemia 4
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Clinical Trial Locations for Cholestyramine

Trials by Country

Trials by Country for Cholestyramine
Location Trials
Germany 8
United States 7
Netherlands 3
Brazil 3
Malaysia 3
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Trials by US State

Trials by US State for Cholestyramine
Location Trials
Kentucky 2
Florida 1
Massachusetts 1
Minnesota 1
Missouri 1
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Clinical Trial Progress for Cholestyramine

Clinical Trial Phase

Clinical Trial Phase for Cholestyramine
Clinical Trial Phase Trials
Phase 4 5
Phase 3 7
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Cholestyramine
Clinical Trial Phase Trials
Completed 20
Recruiting 4
Not yet recruiting 1
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Clinical Trial Sponsors for Cholestyramine

Sponsor Name

Sponsor Name for Cholestyramine
Sponsor Trials
National Heart, Lung, and Blood Institute (NHLBI) 4
Sanofi 3
Louisville Metabolic and Atherosclerosis Research Center 2
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Sponsor Type

Sponsor Type for Cholestyramine
Sponsor Trials
Other 28
Industry 9
NIH 6
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Serving hundreds of leading biopharmaceutical companies globally:

UBS
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Daiichi Sankyo
Express Scripts
AstraZeneca
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Harvard Business School
Healthtrust
US Army

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