Phase 3
N=833
12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe
Hypercholesterolemia · Coronary Heart Disease · Atherosclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00525824 ↗Enrolled (actual)
833
Serious AEs
—
Results posted
Oct 2009
Primary outcome: Primary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment — -59.7200; -63.4800; -55.2200; -57.4200 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rosuvastatin (Crestor) (Drug); Ezetimibe (Drug); Simvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment |
-59.7200; -63.4800; -55.2200; -57.4200 | — |
| SECONDARY Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment |
6.4100; 7.4600; 3.9200; 4.3400 | — |
| SECONDARY Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment |
-43.0000; -46.6300; -39.5600; -41.7100 | — |
| SECONDARY Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment |
-28.8500; -35.0000; -22.9500; -25.8200 | — |
| SECONDARY Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment |
-54.6500; -58.9100; -49.9300; -52.3700 | — |
| SECONDARY Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment |
-46.1100; -49.5000; -41.9500; -44.1700 | — |
| SECONDARY Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment |
3.8100; 2.6800; 1.4900; 2.1300 | — |
| SECONDARY Percent Change in TC/HDL-C After 6 Weeks Combination Treatment |
-45.5200; -49.4600; -41.2700; -43.4500 | — |
| SECONDARY Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment |
-61.4700; -65.2500; -57.1300; -58.6600 | — |
| SECONDARY Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment |
-56.4200; -60.8900; -51.1100; -53.5100 | — |
| SECONDARY Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment |
-47.3900; -50.2400; -42.5400; -44.7600 | — |
| SECONDARY Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment |
107.1200; -9.5300; 15.0300; 0.4200 | — |
| SECONDARY Percent Change in LDL-C After 6 Weeks Monotherapy |
-46.4900; -53.5900; -40.8600; -46.3500 | — |
Summary
The purpose of this study is to determine whether treatment of Rosuvastatin (CRESTOR™) or Simvastatin given as monotherapy or given in combination with Ezetimibe, will lower the Low Density Lipoprotein Cholesterol (LDL-C) in patients with Hypercholesterolaemia and Coronary Heart Disease (CHD) or a CHD Risk Equivalent, Atherosclerosis or a 10-year CHD Risk of >20%
Eligibility Criteria
Inclusion Criteria
- Patients with with hypercholesterolaemia and CHD or a CHD risk equivalent, clinical evidence of atherosclerosis or a Framingham 10-year CHD risk score of >20
- Patients will need to sign an informed consent before any visit procedures can be performed, including procedures for the optional genetic research and biomarker studies.
- Patients must be 18 years or older and will be asked to stop taking any current cholesterol-lowering medications. Dietary counselling will be provided which will include an overview of the Therapeutic Lifestyle Change (TLC) diet the patients will be asked to follow
Exclusion Criteria
- Use of lipid lowering drugs and other prohibited concomitant medications. History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin, simvastatin and/or a history of hypersensitivity to any components of ezetimibe.
- Patients considered to be unstable by their physician after the following events:
a myocardial infarction, recent episode of unstable angina, myocardial revascularisation [percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) surgery or another revascularisation procedure] or a transient ischaemic attack (TIA) or stroke and patients awaiting a planned myocardial revascularisation
Data sourced from ClinicalTrials.gov (NCT00525824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.