CLINICAL TRIALS PROFILE FOR CRESTOR
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505(b)(2) Clinical Trials for CRESTOR
| 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 | >Sponsor | >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. |
| NCT00184951 ↗ | Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients | Completed | AstraZeneca | 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. |
| NCT00184951 ↗ | Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients | Completed | Radboud University | 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. |
| NCT00206310 ↗ | Crestor Versus Placebo in Subjects With Heart Failure | Completed | AstraZeneca | Phase 3 | 2003-09-01 | The purpose of the study is to investigate if rosuvastatin, added on top of all other medicines prescribed to subjects with symptomatic systolic heart failure, reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction or non-fatal stroke (time to first event) |
| NCT00214617 ↗ | Effect of Crestor on Lipoprotein Metabolism in Humans | Completed | AstraZeneca | Phase 4 | 2005-01-01 | The objective of this research is to understand how Crestor can effectively reduce the levels of the bad cholesterol, LDL, in blood. It is hypothesized that with a low dose, Crestor will facilitate the rate of removal of LDL from the blood. At the higher dose, the increased potency of Crestor is explained by a reduction in the production of LDL by the liver. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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