Crestor™ (rosuvastatin) is sometimes referred to in reports by its clinical development research number; ZD4522 . Please consult the prescribing information for the country concerned for guidance on the approved use of Crestor™ (rosuvastatin). Phase IV Studies:
| Study Number | Completed Clinical Trial Report Summaries | 25V06' | Evaluation of the efficacy of rosuvastatin in daily practice (TARGET). | 25V07 | Evaluation of the efficacy of rosuvastatin in daily practice (TARGET). | D3560L00009 | An open-label, randomised, multi-centre, phase IIIb/IV, parallel group study to compare the efficacy and safety of rosuvastatin and atorvastatin in subjects with type IIa and IIb hypercholesterolaemia (DISCOVERY). | |
D3560L00060 | A phase IV, 6-week, randomised, double-blind, multicentre, parallel group, comparative study to evaluate the efficacy of rosuvastatin 5 mg and
atorvastatin 10 mg in UK Asian subjects with primary
hypercholesterolaemia
SHUKRA - Study of Asian patients with Hypercholesterolaemia in the UK Rosuvastatin
5 mg versus Atorvastatin 10 mg | D3560L00039(CASTOR) | A randomised, double-blind, parallel-group, multicentre study comparing the efficacy of rosuvastatin 10 mg (with a possible titration to 40 mg) with atorvastatin 20 mg (with a possible titration to 80 mg) when given for a period of 16 weeks to patients with coronary heart disease and a previously performed percutaneous coronary intervention. |
NL401017
| Crestor in patients with diabetes mellitus type 2: lowering of LDL-C levels to European guidelines (DIALOOG) | NL950057 | Evaluation of the efficacy of rosuvastatin in daily practice in untreated high risk patients and patients with a history of cardiac disease (CHALLENGE). | SRP-CB-CRE-20061 | Centralized Pan-European survey on the undertreatment of hypercholesterolemia |
Phase III Studies:
| Study Number | Completed Clinical Trial Report Summaries | D3560C00044(4522IL/0044) | Randomized, Double-blind, Multicenter Trial to Assess the Effect of High and Low doses of Rosuvastatin on Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Patients with Asymptomatic Carotid Stenosis After 24 Months of Dosing (ORION) | D3560C00069OLE | A 12-Week, Randomised, Double-Blind, Force-Titration, Parallel Group, Multicentre, Phase IIIB Study to Compare the Efficacy of Rosuvastatin with Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atherosclerotic, Metabolic Syndrome Patients with Raised LDL-C and a 10-Year Risk for CHD of >10% | D3560C00069 | A 12-week, randomised, double-blind, force-titration, parallel group, multicentre, phase IIIB study to compare the efficacy of rosuvastatin with atorvastatin and placebo in the treatment of non-diabetic, non-atherosclerotic, metabolic syndrome patients with raised LDL-C and a 10-year risk for CHD of >10% | D3560C00099OLE | A 6-Week Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study, Which Describes the Renal Effects of the Lipid-Regulating Agents Rosuvastatin and Simvastatin in the Treatment of Patients with Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia. |
4522AS/0002
| A randomised, placebo-controlled, parallel-group, multicentre, phase III study to assess the impact of rosuvastatin treatment for 26 weeks (titrated to a maximum dose of 40mg once daily) on left ventricular function, cytokines and lipid parameters in patients with established systolic chronic heart failure. | 4522AS/0003 | A randomised, double-blind, placebo-controlled, crossover pilot study to define the high density lipoprotein cholesterol (HDL-C)-raising mechanism of rosuvastatin (CRESTORTM) by quantifying the key steps of reverse cholesterol transport (RCT). | 4522AS0004 | A randomised, double-blind, placebo controlled, crossover dose-ranging study to investigate the effect of rosuvastatin (CRESTOR®) on high density lipoprotein kinetics in patients with the metabolic syndrome. | 4522IL/0008 | A Randomised, Parallel-Group Dose-Response Study with the HMG-CoA Reductase Inhibitor ZD4522 and Atorvastatin in Subjects with Primary Hypercholesterolaemia | 4522IL/0023 | A Randomised, Double-blind, Parallel-group, Dose-response Study with the HMG-CoA Reductase Inhibitor ZD4522 in Subjects with Primary Hypercholesterolaemia | 4522IL/0024 | A 12-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of ZD4522 5mg and 10 mg and Atorvastatin 10 mg in the Treatment of Subjects with Hypercholesterolemia | 4522IL/0025 | A 24-week, Randomized, Double-blind, Multicenter Trial to Evaluate the Efficacy and Safety of Starting and Maximum Doses of ZD4522 and Atorvastatin in the Treatment of High Risk Hypercholesterolemic Subjects | 4522IL/0026 | A Randomised, Double-blind, Multinational, Multicentre Trial to Compare the Short-term and Long-term Efficacy and Safety of ZD4522 and Atorvastatin in the Treatment of Subjects with Hypercholesterolaemia. | 4522IL/0027 | A 12-Week, Randomised, Double-blind, Multicentre Trial to Evaluate the Efficacy and Safety of ZD4522 (5 and 10 mg), Pravastatin (20 mg), and Simvastatin (20 mg) in the Treatment of Subjects with Hypercholesterolaemia | 4522IL/0028 | A Randomized, Double-blind, Multicenter Trial to Compare the Short-term and Long-term Efficacy and Safety of ZD4522 5 and 10 mg, Simvastatin 20 mg, and Pravastatin 20 mg in the Treatment of Subjects with Hypercholesterolemia | 4522IL/0029 | A 24-Week Randomized Multicenter Trial to Evaluate the Efficacy and Safety of ZD4522 10 to 40 mg and Extended-release Niacin 0.5 to 2g Monotherapy, as well as Selected Combinations of ZD4522 and Extended-release Niacin, in the Treatment of Subjects with Type IIb or IV Hyperlipidemia | 4522IL/0030 | A 24-Week, Randomised, Double-blind, Multicentre, Multinational Trial to Evaluate the Efficacy and Safety of ZD4522 and Atorvastatin in the Treatment of Subjects with Heterozygous Familial Hypercholesterolaemia. |
4522IL/0037
| A 9-Week, Randomised, Double-Blind, Placebo-Controlled Trial to Investigate the Effect of Rosuvastatin on Endothelial Function in Patients with Moderate
Hypercholesterolaemia | 4522IL/0050
| A Randomized, Open-label, Single-center, Parallel-group Trial to Compare the Effects of Treatment with ZD4522 and Gemfibrozil on Postprandial Triglyceride Levels in Patients with Combined Hyperlipidemia | 4522IL/0054
| A 30-Week, Forced-titration and Randomised, Crossover, Multicentre, Multinational Trial to Evaluate the Efficacy and Safety of ZD4522 and Atorvastatin in Subjects with Homozygous Familial Hypercholesterolaemia (4522IL/0054): Report of the First 18 Weeks of Treatment (Open label ZD4522 20/40/80 mg, Forced-titration Period) | 4522IL/0081 | An Open-label Randomised, Multicentre, Phase-IIIb, Parallel-group Switching Study to Compare the Efficacy and Safety of Lipid-lowering Agents Atorvastatin, Pravastatin, Simvastatin and Rosuvastatin in Subjects with Type IIa and IIb Hypercholesterolaemia (MERCURY I) | 4522IL/0065 | A 6-week, Open-label, Dose-comparison Study to Evaluate the Safety and Efficacy of Rosuvastatin Versus Atorvastatin, Pravastatin, and Simvastatin in Subjects with Hypercholesterolemia (STELLAR) | 4522IL/0031 | A 12-Week Randomized, Open-label, Multicenter Trial to Evaluate the Efficacy, Safety, and Tolerability of ZD4522 (80 mg) and the Combination of ZD4522 (80 mg) and Cholestyramine (16 g) in the Treatment of Subjects with Severe Hypercholesterolemia. | 4522IL/0032 | An 18-week, randomised, double-blind, multicentre, placebo-controlled trial to evaluate the efficacy and safety of rosuvastatin (5 and 10 mg) in the treatment of hypercholesterolaemic postmenopausal women receiving hormone replacement therapy | 4522IL/0033 | A 6-week, Randomized, Double-blind, Multicenter Trial to Evaluate the Safety and Efficacy of ZD4522 (5, 10, 20, 40, and 80 mg) and Atorvastatin (10, 20, 40, and 80 mg)Across Their Respective Dose Ranges in the Treatment of Subjects with Hypercholesterolemia | 4522IL/0035 | A 12-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of ZD4522 5 to 80 mg in the Treatment of Subjects with Hypertriglyceridemia | 4522IL/0036 | A 24-Week, Randomised, Multicentre Trial to Evaluate the Efficacy and Safety of ZD4522 and Fenofibrate, Alone and in Various Combinations, in the Treatment of Type IIb and IV Hyperlipidaemia Associated with Type 2 Diabetes Mellitus | 4522IL/0040 | A Randomised, Double-Blind, Placebo-Controlled, Crossover Trial to Investigate the Effect of Rosuvastatin on Lipoproteins in Patients with Differing Atherogenic Lipoprotein Profiles | 4522IL/0055 | A Randomised, Double-Blind, Dose-Response Study with the HMG-CoA Reductase Inhibitor ZD4522 in Subjects with Hyperlipidaemis (A Phase II Clinical Study) | D3560C00081OLE(4522IL/00081OLE) | An Open-Label, Multicentre, Phase IIIb, Extension Study to Assess the
Long-Term Safety of the Lipid-Lowering Agent Rosuvastatin in Subjects
with Type IIa and IIb Hypercholesterolaemia | D3560C00099(4522IL/0099) | A 6-Week Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study, Which Describes the Renal Effects of the Lipid-Regulating Agents Rosuvastatin and Simvastatin in the Treatment of Patients with Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia. | D3560l00021 | A 12-Week, Randomized, Open-Label, 3-Arm, Parallel Group, Multicenter, Phase IIIb Study Comparing the Efficacy and Safety of Rosuvastatin 20 mg and 40 mg with that of Atorvastatin 80 mg in Patients with Acute Coronary Syndromes (LUNAR) | D3560L00038 | Evaluation of the hs-CRP reducing Effect of Rosuvastatin - a placebo controlled randomized multicentre phase IIIb study in hypertensive patients with an increased global risk of developing fatal cardiovascular disease - the ELECTRA study. | D3560L00011 | Rosuvastatin 10 mg treatment is significantly more effective in achieving European LDL-C goals than atorvastatin 10 mg, with a similar safety and tolerability profile. Up-titration to rosuvastatin 20 mg and switch from atorvastatin 10 mg to rosuvastatin 10 mg allowed more patients to reach European LDL-C target goal after 24 weeks. This study confirms the efficacy and safety profile of rosuvastatin in a Belgian and Luxemburger population. | D3560C00068 | An Open-label, Randomized, Multi-center, Phase IIIb, Parallel Group Switching Study to Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin with Rosuvastatin in High Risk Subjects with Type IIa and IIb Hypercholesterolemia (MERCURY II). | D3560C00068OLE | An Open-label, Randomized, Multi-center, Phase IIIb, Parallel Group Switching Study to Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin with Rosuvastatin in High Risk Subjects with Type IIa and IIb Hypercholesterolemia (MERCURY II). | D3560C00065 | A 6-Week, Open-Label, Dose-Comparison Study to Evaluate the Safety and Efficacy of Rosuvastatin Versus Atorvastatin, Pravastatin, and Simvastatin in Subjects with Hypercholesterolemia (STELLAR). | D3560C00034 | An Open-label, Multinational, Multicenter Extension Trial to Assess the Longterm Safety and Efficacy of ZD4522 in Subjects in the ZD4522 Clinical Trial Program. | D3560L00027(4522US_0007) | Report on the Randomized Treatment Phase. A 6-week, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin and Atorvastatin in the Treatment of Hypercholesterolemia in Hispanic Subjects (STARSHIP). | D3560L00027_OLE (4522US/0007) | Final Report with Extension Phase and Overall Safety Data. A 6-week, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin and Atorvastatin in the Treatment of Hypercholesterolemia in Hispanic Subjects (STARSHIP). | ZD4522/CN/01 | A 12-Week Randomised Double-blind Multicentre Trial to Evaluate the Efficacy and Safety of Rosuvastatin 10 mg and Atorvastatin 10 mg in the Treatment of Subjects With Hypercholesterolemia | D3560L00026 OLE/4522US0006_OLE_OLE | Final Report with Extension Phase Data A 6-week, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin and Atorvastatin in the Treatment of Hypercholesterolemia in South Asian Subjects (IRIS) | D3560L00023 | Report with Randomized Treatment and Extension Phase Data
A 12-Week, Randomized, Open-label, 3-Arm Parallel-group, Multicenter, Phase IIIb
Study Comparing the Efficacy and Safety of Rosuvastatin with Atorvastatin and
Simvastatin Achieving NCEP ATP III LDL-C Goals in High-risk Subjects with
Hypercholesterolemia in the Managed Care Setting (SOLAR Study) | D3560L00026/4522US0006 | A 6-week, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin and Atorvastatin in the Treatment of Hypercholesterolemia in South Asian Subjects (IRIS) | 4522IL/0106 (D3569C00005) | Trial title: A 26-week, Double-blind, Randomised, Multicentre, Phase IIIb, Parallel-group Study to Compare the Efficacy and Safety of Rosuvastatin (40 mg) with Atorvastatin (80 mg) in Subjects with Hypercholesterolaemia and Coronary Heart Disease (CHD) or CHD Risk Equivalents.
POLARIS - Prospective Optimisation of Lipids by Atorvastatin or Rosuvastatin Investigated in high-risk Subjects with hypercholesterolaemia
| 4522SP-0001 | A multicenter, randomized, double-blind, parallel-group, dose titration (10 mg and 20 mg) study to compare the efficacy and safety of Rosuvastatin versus Atorvastatin in patients with primary hypercholesterolemia | 4522IL/0102 (D3569C00001) 31 | A 6-week Open-label, Randomised, Multicentre, Phase IIIb, Parallel-group Study to Compare the Efficacy and Safety of Rosuvastatin (10 mg) with Atorvastatin (20 mg) in Subjects with Hypercholesterolaemia and Either a History of Coronary Heart Disease (CHD) or Clinical Evidence of Atherosclerosis or a CHD Risk Equivalent (10-year Risk Score of >20%)
PULSAR – A Prospective study to evaluate the Utility of Low doses of the Statins Atorvastatin and Rosuvastatin. | D3562C00076 (4522IL/0076) | A 104-Week, Open-label, Multi-center, Phase IIIb Study Evaluating the Effect of Treatment with Rosuvastatin 40 mg on Atherosclerotic Disease as Measured by Intravascular Ultrasound and Quantitative Coronary Angiography in Subjects Undergoing Coronary Angiography who have Coronary Artery Disease .
A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden (ASTEROID)
| D3562C00098 | A Randomized, Double-Blind, Placebo Controlled Phase III Study with
Rosuvastatin in Subjects with Chronic Symptomatic Systolic Heart Failure | D3569C00006 | 6-week, Open-label, Randomised, Multicentre, Phase IIIb, Parallel-group Study to Compare the Safety and Efficacy of Rosuvastatin 40 mg and Rosuvastatin 40 mg in Combination with Ezetimibe 10 mg in Subjects with Hypercholesterolaemia and Coronary Heart Disease (CHD) or Atherosclerosis or a CHD Risk Equivalent (10-year Risk Score of >20%) EXPLORER -EXamination of Potential Lipid-modifying effects Of Rosuvastatin in combination with Ezetimibe versus Rosuvastatin alone | D3560L00022OLE | A 6-Week, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin and Atorvastatin in the Treatment of Hypercholesterolemia in African-American Subjects (ARIES). | D3560L00022/4522US0002 | A 6-Week, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin and Atorvastatin in the Treatment of Hypercholesterolemia in African-American Subjects.
Report on the Randomized Treatment Phase | D3560C00071 | An 18-Week, Randomized, Multicenter, Phase IIIb, Double-Blind, Crossover
Study, Followed by an 18-Week Open-Label Period to Evaluate the Efficacy
and Safety of the Lipid-Regulating Agents, Rosuvastatin and Pravastatin in
the Treatment of Subjects with Dysbetalipoproteinemia
(Fredrickson type III Hyperlipoproteinemia) | D3562C00088 (4522IL/0088) | A Randomized, Double-blind, Placebo-controlled, Multicenter Parallel Group Phase III Study Measuring Effects on Intima Media Thickness: an Evaluation Of Rosuvastatin 40 mg (METEOR) | D3560C00091 | A 48-Week Open-Label, Non-Comparative, Multicentre, Phase IIIb Study To Evaluate The Efficacy and Safety of the Lipid-Regulating Agent Rosuvastatin in the Treatment of Patients with Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia. | D3569C00002 | A 24-week, Randomised, Open-label, Parallel-group, Multicentre Study
which Compares the Efficacy and Safety of Rosuvastatin 10, 20 and 40 mg
with Atorvastatin 10, 20, 40 and 80 mg when Force-titrated in the Treatment
of Patients with Primary Hypercholesterolemia and Either a History of
Coronary Heart Disease (CHD) or Clinical Evidence of Atherosclerosis or a
CHD Risk Equivalent (10-year Risk Score >20%)
ECLIPSE - An Evaluation to Compare Lipid-lowering effects of rosuvastatin and
atorvastatin In force-titrated patients: a Prospective Study of Efficacy and
tolerability | D3560C00091OLE | A 48-Week Open-Label, Non-Comparative, Multicentre, Phase IIIb Study, to Evaluate the Efficacy and Safety of the Lipid-Regulating Agent Rosuvastatin in the Treatment of Patients with Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia. |
| Study Number | Clinical Trial Title | 4522IL/0009 | A Phase I Trial to Assess the Effect of Coadministration of Oral Contraceptives and ZD4522 (40 mg) on the Pharmacokinetics of Exogenous Plasma Estrogen and Progesterone in Healthy Women | 4522IL/0013 | A Randomised, Double-Blind, 2-Way Crossover Trial to Assess the Effect of ZD4522 (40 mg) on the Pharmacokinetics of a Single Oral Dose of Digoxin in Healthy Male Volunteers | 4522IL/0015 | An Open, Non-Randomised, Parallel-Group, Non-Controlled, Phase I Trial to Assess the Effect of Age and Gender on the Pharmacokinetics of a Single 40 mg Oral Dose of ZD4522 in Healthy Male and Female Volunteers | 4522IL/0018 | Pharmacokinetics and Pharmacodynamics of ZD4522 10 mg in Subjects with Hepatic Impairment | | 4522IL/0021 | The Pharmacokinetics of ZD4522 (10 mg and 20 mg) in Stable Cardiac Transplant Subjects Taking an Anti-rejection Regimen Containing Cyclosporine | 4522IL/0022 | A Randomised, Non-controlled, Single-centre, Open-label, 3-way Crossover Trial to Assess the Effect of Co-administration of ZD4522 and Fenofibrate on the Pharmacokinetics of Each Compound in Healthy Male Volunteers | 4522IL/0048 | A Single Centre, Randomised, Double-blind, 2-Way Crossover Trial to Assess the Effect of Fluconazole, a CYP2C9/2C19 Inhibitor, on the Pharmacokinetics of a Single Dose of ZD4522 80 mg in Healthy Male Volunteers | 4522IL/0053 | A Single Centre, Randomised, Double-blind, 2-way Crossover Trial to Assess the Effect of Itraconazole, a CYP3A4 Inhibitor, on the Pharmacokinetics of a Single Dose of ZD4522 80 mg in Healthy Male Volunteers | 4522IL/0057 | A Single Centre, Randomised, Double-blind, 2-Way Crossover Trial to Assess the Effect of Ketoconazole, a CYP3A4 Inhibitor, on the Pharmacokinetics of a Single Oral Dose of ZD4522 80 mg in Healthy Male Volunteers | 4522IL/0058 | A Single Centre, Randomised, Double-blind, 2-Way Crossover Trial to Assess the Effect of Erythromycin, a CYP3A4 Inhibitor, on the Pharmacokinetics of a Single Oral Dose of ZD4522 80 mg in Healthy Male Volunteers | 4522IL/0095 | A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, 2-Way Crossover Trial to Assess the Effect of Gemfibrozil on the Pharmacokinetics of a Single Oral Dose of Rosuvastatin 80 mg in Healthy Men and Women |
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