Rosuvastatin

Generic Name: Rosuvastatin

Brand Names: Crestor, Ezallor, Roszet

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₈FN_₃O_₆S

CAS Number: 287714-41-4

Unique Ingredient Identifier: 413KH5ZJ73

Background: Rosuvastatin, also known as the brand name product Crestor, is a lipid-lowering drug that belongs to the statin class of medications, which are used to lower the risk of cardiovascular disease and manage elevated lipid levels by inhibiting the endogenous production of cholesterol in the liver. More specifically, statin medications competitively inhibit the e...

Indication: The FDA monograph states that rosuvastatin is indicated as an adjunct to diet in the treatment of triglyceridemia, Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia), and Homozygous Familial Hypercholesterolemia.
...

Associated Conditions: Atherosclerosis, Atherosclerotic Cardiovascular Diseases, Cardiovascular Disease (CVD), Cardiovascular Events, Dysbetalipoproteinemia, Heterozygous Familial Hypercholesterolemia (HeFH), High Cholesterol, Homozygous Familial Hypercholesterolaemia (HoFH), Hypertension, Hypertension, Essential Hypertension, Hypertriglyceridemias, Major Adverse Cardiovascular Events, Mixed Dyslipidemias, Postoperative Thromboembolism, Primary Hypercholesterolemia, Primary Hyperlipidemia

Associated Therapies: Lipid-Lowering Therapy, Primary Prevention of Cardiovascular Diseases

Clinical Trials

CRESTOR Athero Imaging Head to Head IVUS Study

Phase 3

Completed

Conditions: Coronary Atherosclerosis

Interventions: Drug: Atorvastatin
Drug: Rosuvastatin

First Posted Date: 2008-02-21

Last Posted Date: 2012-07-16

Lead Sponsor: AstraZeneca

Target Recruit Count: 2333

Registration Number: NCT00620542

Locations: 🇪🇸
Research Site, Alicante, Comunidad Valenciana, Spain

Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly

Phase 1

Completed

Conditions: Dyslipidemia, Renal Insufficiency

Interventions: Drug: ABT-335
Drug: Rosuvastatin

First Posted Date: 2008-01-03

Last Posted Date: 2012-09-28

Lead Sponsor: AstraZeneca

Target Recruit Count: 37

Registration Number: NCT00585143

Locations: 🇺🇸
Site Reference ID/Investigator# 6738, Miami, Florida, United States
🇺🇸
Site Reference ID/Investigator# 7723, Minneapolis, Minnesota, United States
🇺🇸
Site Reference ID/Investigator# 8280, Richmond, Virginia, United States

and more 3 locations

Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis

Phase 2

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Placebo
Drug: Rosuvastatin

First Posted Date: 2007-11-08

Last Posted Date: 2011-01-27

Lead Sponsor: Chinese University of Hong Kong

Target Recruit Count: 150

Registration Number: NCT00555230

Locations: 🇨🇳
School of Pharmacy CUHK, Hong Kong, China

The Effect of Rosuvastatin on Adenosine Metabolism

Not Applicable

Completed

Conditions: Adenosine Metabolism

Interventions: Drug: placebo
Drug: rosuvastatin

First Posted Date: 2007-11-06

Last Posted Date: 2008-09-23

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 24

Registration Number: NCT00554138

Locations: 🇳🇱
Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands

Evaluate the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Type 2 Diabetic Patients With Dyslipidemia

Phase 4

Completed

Conditions: Diabetes Mellitus
Dyslipidemia

Interventions: Drug: Simvastatin
Drug: Rosuvastatin

First Posted Date: 2007-07-25

Last Posted Date: 2011-12-06

Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Target Recruit Count: 90

Registration Number: NCT00506961

Locations: 🇨🇳
Taichung Veterans General Hospital, Taichung, Taiwan
🇨🇳
Taipei Veterans General Hospital, Taipei, Taiwan

Effect of Rosuvastatin on Left Ventricular Remodeling

Phase 3

Completed

Conditions: Dilated Cardiomyopathy

Interventions: Drug: placebo
Drug: Rosuvastatin

First Posted Date: 2007-07-23

Last Posted Date: 2014-01-27

Lead Sponsor: Oslo University Hospital

Target Recruit Count: 75

Registration Number: NCT00505154

Locations: 🇳🇴
Oslo University Hospital, Oslo, Norway

Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients

Phase 4

Completed

Conditions: Hypertriglyceridemia
Hyperlipoproteinemia Type IV
Hyperlipoproteinemia Type V
Hyperlipoproteinemia Type IIb
Hyperlipidemia

First Posted Date: 2007-05-15

Last Posted Date: 2010-12-16

Lead Sponsor: AstraZeneca

Target Recruit Count: 334

Registration Number: NCT00473655

Locations: 🇲🇽
Research Site, Monterrey, Nuevo Leon, Mexico

Heart Outcomes Prevention Evaluation-3

Phase 4

Completed

Conditions: Cardiovascular Disease
Stroke

Interventions: Drug: Rosuvastatin
Drug: Candesartan/HCT

First Posted Date: 2007-05-03

Last Posted Date: 2017-10-25

Lead Sponsor: Population Health Research Institute

Target Recruit Count: 12705

Registration Number: NCT00468923

Locations: 🇨🇦
Hamilton General Hospital, Hamilton, Ontario, Canada

Does Caffeine Reduce Rosuvastatin-Induced Protection Against Ischemia-Reperfusion Injury?

Phase 4

Completed

Conditions: Ischemia Reperfusion Injury

Interventions: Drug: Rosuvastatin

First Posted Date: 2007-04-06

Last Posted Date: 2008-04-15

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 24

Registration Number: NCT00457652

Locations: 🇳🇱
UMCN st.Radboud, Nijmegen, Netherlands

Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C

Phase 2

Completed

Conditions: Hepatitis C

First Posted Date: 2007-03-13

Last Posted Date: 2008-09-09

Lead Sponsor: Bader, Ted, M.D.

Target Recruit Count: 16

Registration Number: NCT00446940

Locations: 🇺🇸
VA Hospital, OKlahoma City, Oklahoma, United States

Drug Development Updates

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