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Last Updated: December 22, 2024

CLINICAL TRIALS PROFILE FOR CRESTOR


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505(b)(2) Clinical Trials for CRESTOR

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT04846231 ↗ Supplements, Placebo, or Rosuvastatin Study Recruiting AstraZeneca Phase 2 2021-04-23 A research study that is evaluating a low dose of an FDA approved statin medication in comparison to several commercially available over the counter dietary supplements which are marketed for cholesterol health. The study is comparing their effect on LDL cholesterol. LDL-cholesterol is low-density cholesterol and is sometimes referred to as "bad" cholesterol. Participants must live in Ohio and have a documented elevated LDL cholesterol level between 70-189mg/dL, must not currently be taking a statin or one of the dietary supplements included in the trial. Participants willing to discontinue a prohibited supplement for 4 weeks prior to enrollment will be allowed to participate. Trial participation is 4 weeks. Study medication will be provided at no charge. There will be 2 visits which include a lab draw at any Cleveland Clinic laboratory. Participants will be randomized (like a coin flip) to be in one of 8 possible groups: Rosuvastatin, Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice, or placebo. The study will enroll 200 participants.
OTC NCT04846231 ↗ Supplements, Placebo, or Rosuvastatin Study Recruiting The Cleveland Clinic Phase 2 2021-04-23 A research study that is evaluating a low dose of an FDA approved statin medication in comparison to several commercially available over the counter dietary supplements which are marketed for cholesterol health. The study is comparing their effect on LDL cholesterol. LDL-cholesterol is low-density cholesterol and is sometimes referred to as "bad" cholesterol. Participants must live in Ohio and have a documented elevated LDL cholesterol level between 70-189mg/dL, must not currently be taking a statin or one of the dietary supplements included in the trial. Participants willing to discontinue a prohibited supplement for 4 weeks prior to enrollment will be allowed to participate. Trial participation is 4 weeks. Study medication will be provided at no charge. There will be 2 visits which include a lab draw at any Cleveland Clinic laboratory. Participants will be randomized (like a coin flip) to be in one of 8 possible groups: Rosuvastatin, Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice, or placebo. The study will enroll 200 participants.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for CRESTOR

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00079638 ↗ Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL Completed Kos Pharmaceuticals Phase 4 2004-04-01 The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are a class of medication that is often prescribed to patients who need to lower their cholesterol levels.
NCT00115830 ↗ Rho Kinase in Patients With Atherosclerosis Completed Brigham and Women's Hospital Phase 3 2004-12-01 The purpose of the study is to investigate the effects of atorvastatin (Lipitor) and rosuvastatin (Crestor), United States Food and Drug Administration (FDA) approved drugs commonly prescribed by doctors to lower cholesterol, on certain functions of platelets (cells that cause blood clots), white blood cells (cells that are responsible for inflammation), and blood flow regulation by arteries. This is important because we are looking at ways to more effectively prevent atherosclerosis (plaque buildup in blood vessels) and heart disease. Many studies have demonstrated that these drugs are effective at reducing inflammation and stabilizing plaques. We are interested in better understanding the effects of these medicines on inflammation (pain and swelling) and the mechanism by which they act. Hypothesis: Atorvastatin (40mg) will reduce inflammatory markers and activity more than Rosuvastatin (10mg) in spite of equal LDL-C reduction.
NCT00184951 ↗ Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients Completed Abbott Phase 2 2004-04-01 open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CRESTOR

Condition Name

Condition Name for CRESTOR
Intervention Trials
Hypercholesterolemia 29
Atherosclerosis 18
Healthy 14
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Condition MeSH

Condition MeSH for CRESTOR
Intervention Trials
Hypercholesterolemia 37
Atherosclerosis 22
Myocardial Ischemia 20
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Clinical Trial Locations for CRESTOR

Trials by Country

Trials by Country for CRESTOR
Location Trials
United States 393
Canada 76
Italy 36
Japan 35
Mexico 34
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Trials by US State

Trials by US State for CRESTOR
Location Trials
California 18
Texas 17
Ohio 17
Florida 13
North Carolina 13
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Clinical Trial Progress for CRESTOR

Clinical Trial Phase

Clinical Trial Phase for CRESTOR
Clinical Trial Phase Trials
Phase 4 46
Phase 3 42
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for CRESTOR
Clinical Trial Phase Trials
Completed 126
Unknown status 18
Terminated 15
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Clinical Trial Sponsors for CRESTOR

Sponsor Name

Sponsor Name for CRESTOR
Sponsor Trials
AstraZeneca 48
Odense University Hospital 4
Merck Sharp & Dohme Corp. 4
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Sponsor Type

Sponsor Type for CRESTOR
Sponsor Trials
Other 130
Industry 113
NIH 7
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