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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR PRAVASTATIN SODIUM

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Clinical Trials for Pravastatin Sodium

Trial ID Title Status Sponsor Phase Summary
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.
NCT00232882 Pharmacodynamic Influences of Candesartan, Atenolol, Hydrochlorothiazide and Drug Combinations in Hypertensive Patients. Completed Ottawa Hospital Research Institute Phase 4 Angiotensin receptor antagonists (ARA), beta-blockers and diuretics do not seem to confer equivalent cardiovascular protection in hard outcomes clinical trials (beta blockers inferior). These results may be explained by differences in their effects on sympathetic activity, oxidative stress, inflammation and renin angiotensin system activation. How diuretic addition to first line therapy with ARAs and beta-blockers modulates neurohumoral and hemodynamic parameters is not well understood. The main hypothesis of this study is that an ARA (candesartan) combined or not with a diuretic will not increase sympathetic activity as much as a beta blocker (atenolol). Secondary hypothesis are of similar nature but relate to hemodynamic parameters, oxidative stress markers, inflammatory markers, or the renin angiotensin system. The main objective of this study is to assess and compare the effects of candesartan and atenolol and their combination with low dose diuretic therapy on the autonomic nervous system, hemodynamic parameters,on oxidative stress, on inflammatory markers, and on the renin-angiotensin system. Protocol sponsored by Astra Zeneca canada
NCT00232882 Pharmacodynamic Influences of Candesartan, Atenolol, Hydrochlorothiazide and Drug Combinations in Hypertensive Patients. Completed Institut de Recherches Cliniques de Montreal Phase 4 Angiotensin receptor antagonists (ARA), beta-blockers and diuretics do not seem to confer equivalent cardiovascular protection in hard outcomes clinical trials (beta blockers inferior). These results may be explained by differences in their effects on sympathetic activity, oxidative stress, inflammation and renin angiotensin system activation. How diuretic addition to first line therapy with ARAs and beta-blockers modulates neurohumoral and hemodynamic parameters is not well understood. The main hypothesis of this study is that an ARA (candesartan) combined or not with a diuretic will not increase sympathetic activity as much as a beta blocker (atenolol). Secondary hypothesis are of similar nature but relate to hemodynamic parameters, oxidative stress markers, inflammatory markers, or the renin angiotensin system. The main objective of this study is to assess and compare the effects of candesartan and atenolol and their combination with low dose diuretic therapy on the autonomic nervous system, hemodynamic parameters,on oxidative stress, on inflammatory markers, and on the renin-angiotensin system. Protocol sponsored by Astra Zeneca canada
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.
NCT00307307 Carotid Atherosclerosis Regression at Magnetic Resonance Assessment. Completed Merck Sharp & Dohme Corp. 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.
NCT00307307 Carotid Atherosclerosis Regression at Magnetic Resonance Assessment. Completed The Dana Foundation 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 Pravastatin Sodium

Condition Name

Condition Name for Pravastatin Sodium
Intervention Trials
Healthy 6
Adult Acute Myeloid Leukemia With Del(5q) 2
Adult Pure Erythroid Leukemia (M6b) 2
Adult Acute Megakaryoblastic Leukemia (M7) 2
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Condition MeSH

Condition MeSH for Pravastatin Sodium
Intervention Trials
Leukemia, Monocytic, Acute 2
Leukemia, Megakaryoblastic, Acute 2
Leukemia, Erythroblastic, Acute 2
Leukemia 2
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Clinical Trial Locations for Pravastatin Sodium

Trials by Country

Trials by Country for Pravastatin Sodium
Location Trials
United States 15
Canada 7
Greece 2
Korea, Republic of 1
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Trials by US State

Trials by US State for Pravastatin Sodium
Location Trials
Texas 2
Missouri 2
Washington 2
North Dakota 1
Maryland 1
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Clinical Trial Progress for Pravastatin Sodium

Clinical Trial Phase

Clinical Trial Phase for Pravastatin Sodium
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Pravastatin Sodium
Clinical Trial Phase Trials
Completed 14
Recruiting 3
Withdrawn 2
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Clinical Trial Sponsors for Pravastatin Sodium

Sponsor Name

Sponsor Name for Pravastatin Sodium
Sponsor Trials
Teva Pharmaceuticals USA 4
National Cancer Institute (NCI) 2
Mylan Pharmaceuticals 2
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Sponsor Type

Sponsor Type for Pravastatin Sodium
Sponsor Trials
Other 18
Industry 13
NIH 4
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Serving hundreds of leading biopharmaceutical companies globally:

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Federal Trade Commission
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US Army
Boehringer Ingelheim
Argus Health
Express Scripts
Colorcon
Chinese Patent Office

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