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Generated: February 20, 2019

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CLINICAL TRIALS PROFILE FOR PRAVACHOL

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Clinical Trials for Pravachol

Trial ID Title Status Sponsor Phase Summary
NCT00166036 Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells Completed Emory University Phase 2 Thirty-six subjects with hyperlipidemia and metabolic syndrome and/or diabetes were randomized in a double-blind manner to either pravastatin 80 mg or atorvastatin 10 mg daily. Oxidative stress (dROMs assay that measures lipid hydroperoxides, plasma thiobarbituric acid reactive substances [TBARS], and aminothiol levels) and brachial artery flow-mediated dilation (FMD) were measured at baseline and after 12 weeks of statin therapy.
NCT00360217 The Triglyceride Lowering Effect of an Omega-3 Fat (DHA) in Addition to Statin Therapy for Patients With CAD or Diabetes Completed Maine Center for Lipids and Cardiovascular Health N/A This study will explore the ability of an algae (ocean plant) omega-3 fat supplement (DHA) to reduce triglyceride levels in patients currently being treated with statin therapy (Zocor or simvastatin, Lipitor or atorvastatin, Pravachol or pravastatin, Crestor or rosuvastatin, etc.) for coronary artery disease(CAD)or risk equivalents (any of the following: heart attack, post angioplasty or stent, post coronary bypass surgery, angina, vascular disease, stroke or diabetes). The rationale for the study is based around the finding that patients with CAD have an approximately 20 % reduction in the risk of sudden death when treated with fish oil (DHA is one of the ingredients in fish oil). In studies of statin-based therapies, it has been observed that statins reduce the risk of coronary events 20-45%. There has not yet been research trials exploring the combination of the two ingredients (i.e., DHA plus statin) in patient treatment either to reduce recurrent cardiac events or to address another reported finding of fish oils to lower triglyceride levels (triglyceride is a form of "blood fat"). This research project will be a pilot project to assess the safety and effectiveness of DHA "add-on" therapy in patients currently being treated with statins for CAD. The study hypothesis is to test the effectiveness of DHA as compared to placebo to lower triglyceride levels in the blood. This is a double-blinded randomized clinical trial.
NCT00467831 Pilot Study of a Multi-Drug Regimen for Severe Pulmonary Fibrosis in Hermansky-Pudlak Syndrome Terminated National Human Genome Research Institute (NHGRI) Phase 1/Phase 2 This study will examine whether five drugs (pravastatin, Losartan, Zileuton, N-acetylcysteine and erythromycin) used together can slow the course of pulmonary fibrosis (scarring of the lung tissue) in patients with Hermansky-Pudlak Syndrome (HPS). Patients with this disease have decreased skin color (albinism), bleeding problems, and sometimes colon problems. Two of the known types of Hermansky Pudlak syndrome, type 1 and type 4, are at high risk of pulmonary fibrosis between the ages of 30 and 50. Patients 18 to 70 years of age who have Hermansky-Pudlak Syndrome with a serious loss of lung function due to pulmonary fibrosis may be eligible for this study. Participants begin taking pravastatin on study day 2 and start a new drug every 3 days. Patients who experience no problems with the medicines return home and continue on the drugs for the next 2 years. They return to the NIH Clinical Center every 3 months for a medical history, physical examination, and blood, urine and lung function tests. CT and bone density scans are done every year. The study may continue for up to 3 years.
NCT00532311 Efficacy of Lapaquistat Acetate Co-Administered With Statins in Subjects With Hypercholesterolemia Terminated Takeda Phase 3 The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with statins on cholesterol levels in subjects with hypercholesterolemia
NCT00630734 Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin Completed Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA Phase 4 Pravastatin (Pravachol) is approved by the Food and Drug Administration (FDA) and is used to treat high cholesterol. Darunavir (Prezista) and ritonavir (Norvir) are approved by the Food and Drug Administration (FDA) to treat HIV infection. When darunavir and ritonavir are given with pravastatin, they can increase the blood levels of pravastatin. The degree of this interaction varies from person to person. The way that darunavir and ritonavir interact with pravastatin may be affected by a person's genetic make-up. Genetic factors (or DNA) are those that people are born with and that make each person unique. Genetic differences are the reason why one person's body traits such as height and hair color are different from another person's body traits. Genetic differences can also affect the way a medication works in the body or the way two medications interact in the body. The purpose of this clinical study is to determine if a person's genetic make-up affects the way darunavir and ritonavir interact with pravastatin in the body.
NCT00630734 Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin Completed University of Colorado, Denver Phase 4 Pravastatin (Pravachol) is approved by the Food and Drug Administration (FDA) and is used to treat high cholesterol. Darunavir (Prezista) and ritonavir (Norvir) are approved by the Food and Drug Administration (FDA) to treat HIV infection. When darunavir and ritonavir are given with pravastatin, they can increase the blood levels of pravastatin. The degree of this interaction varies from person to person. The way that darunavir and ritonavir interact with pravastatin may be affected by a person's genetic make-up. Genetic factors (or DNA) are those that people are born with and that make each person unique. Genetic differences are the reason why one person's body traits such as height and hair color are different from another person's body traits. Genetic differences can also affect the way a medication works in the body or the way two medications interact in the body. The purpose of this clinical study is to determine if a person's genetic make-up affects the way darunavir and ritonavir interact with pravastatin in the body.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Pravachol

Condition Name

Condition Name for Pravachol
Intervention Trials
Healthy 6
Hypercholesterolemia 3
Therapeutic Equivalency 2
Hyperlipidemia 2
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Condition MeSH

Condition MeSH for Pravachol
Intervention Trials
Hypercholesterolemia 3
Myocardial Ischemia 2
Hyperlipidemias 2
Coronary Disease 2
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Clinical Trial Locations for Pravachol

Trials by Country

Trials by Country for Pravachol
Location Trials
United States 44
Canada 5
China 1
Sweden 1
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Trials by US State

Trials by US State for Pravachol
Location Trials
Massachusetts 3
Maryland 2
Maine 2
Georgia 2
Pennsylvania 2
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Clinical Trial Progress for Pravachol

Clinical Trial Phase

Clinical Trial Phase for Pravachol
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Pravachol
Clinical Trial Phase Trials
Completed 16
Recruiting 2
Terminated 2
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Clinical Trial Sponsors for Pravachol

Sponsor Name

Sponsor Name for Pravachol
Sponsor Trials
Teva Pharmaceuticals USA 4
Dr. Reddy's Laboratories Limited 2
Mylan Pharmaceuticals 2
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Sponsor Type

Sponsor Type for Pravachol
Sponsor Trials
Industry 14
Other 10
U.S. Fed 1
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Daiichi Sankyo
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Cerilliant
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Express Scripts
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