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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR GEMFIBROZIL

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Clinical Trials for Gemfibrozil

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.
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.
NCT00039663 Endothelial Dysfunction as a Risk Factor in HIV Study Completed National Institutes of Health Clinical Center (CC) Phase 1 Highly active antiretroviral therapy (HAART) has proven effective in altering the natural history of HIV infection in many patients. However, this therapy may not be sustainable because of the toxicities of the medications. Evidence suggests that HIV-infected patients on HAART may be at risk for premature coronary artery disease. The exact cause is unknown. It is possible that the medications directly affect the endothelium (the lining of the arteries that supply blood to the heart) and lead to premature heart disease. Or because the medications cause lipid abnormalities (high cholesterol) and a condition of relative insulin resistance, in which the body has a difficult time processing sugars; known risk factors for endothelial dysfunction and heart disease. Therapeutic intervention that reverses these lipid abnormalities and/or insulin resistance may lower these risk factors, normalize endothelial function, and decrease the risk of heart disease. This protocol aims to assess endothelial function among a group of HIV-infected patients with varying degrees of viral activity and levels of immune function on a variety of HAART regimens. It also aims to evaluate the effect of three different medications on lipids, insulin resistance, and thus endothelial function. Understanding the factors involved in causing endothelial dysfunction will help better characterize the relative risks and benefits of early versus late and continuous versus intermittent HAART therapy. The research may offer some insights into the causes of premature heart disease among HIV-infected patients on HAART that could be more thoroughly investigated in subsequent clinical trials. A total of 75 patients will be recruited: 25 for each arm of the study. Each arm evaluates the potential benefit of a particular medication and will enroll sequentially. An endothelial function test will be performed on an outpatient basis. The first 25 patients will be assigned at random to receive pravastatin sodium or placebo; the next 25 will receive gemfibrozil or placebo; the final 25 will receive rosiglitazone or placebo. Patients will take the pills for 6 weeks, no pills for the next 4 weeks, and then the opposite treatment for 6 more weeks. Two weeks after the start of the study drug, blood will be taken to check for potential toxic side effects. After each 6-week treatment, blood will be drawn and endothelial function tests will be performed.
NCT00108511 Effect of Gemfibrozil on Serum Glycosylphosphatidylinositol (GPI) Phospholipase D and Triglycerides Completed VA Office of Research and Development Phase 1 The purpose of this study is to examine the role of glycosylphosphatidylinositol-specific phospholipase D (GPI-PLD) in triglyceride metabolism.
NCT00120289 Niacin Plus Statin to Prevent Vascular Events Terminated Abbott Phase 3 The purpose of this study is to determine whether raising "good cholesterol" with a drug based on the vitamin niacin, while lowering "bad cholesterol" with a statin drug, can prevent more heart disease than the statin alone.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Gemfibrozil

Condition Name

Condition Name for Gemfibrozil
Intervention Trials
Healthy Subjects 4
Healthy Volunteers 3
Hypertriglyceridemia 3
Healthy 3
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Condition MeSH

Condition MeSH for Gemfibrozil
Intervention Trials
Diabetes Mellitus, Type 2 4
Hypertriglyceridemia 4
Coronary Disease 3
Coronary Artery Disease 3
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Clinical Trial Locations for Gemfibrozil

Trials by Country

Trials by Country for Gemfibrozil
Location Trials
United States 56
Canada 10
United Kingdom 2
Germany 2
Sweden 1
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Trials by US State

Trials by US State for Gemfibrozil
Location Trials
Texas 4
Maryland 4
Florida 3
Arizona 3
Indiana 3
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Clinical Trial Progress for Gemfibrozil

Clinical Trial Phase

Clinical Trial Phase for Gemfibrozil
Clinical Trial Phase Trials
Phase 4 5
Phase 3 2
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Gemfibrozil
Clinical Trial Phase Trials
Completed 26
Recruiting 4
Terminated 2
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Clinical Trial Sponsors for Gemfibrozil

Sponsor Name

Sponsor Name for Gemfibrozil
Sponsor Trials
GlaxoSmithKline 4
National Institutes of Health Clinical Center (CC) 3
Eli Lilly and Company 2
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Sponsor Type

Sponsor Type for Gemfibrozil
Sponsor Trials
Industry 23
Other 17
NIH 6
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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Cipla
UBS
Cerilliant
Fish and Richardson
Federal Trade Commission
Cantor Fitzgerald
Merck
Boehringer Ingelheim

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