OPEN, RANDOMIZED, PARALLEL GROUP, MULTICENTER, 12-WEEK DURATION STUDY, TO COMPARE THE EFFICACY AND SAFETY OF ROSUVASTATIN (CRESTOR®) 10 MG AND 20 MG IN COMBINATION WITH EZETIMIBE 10 MG AND SIMVASTATIN 40 MG AND 80 MG IN COMBINATION WITH EZETIMIBE 10 MG (COMBINATION WITH FIXED DOSAGE) IN PATIENTS WITH HYPERCHOLESTEROLEMIA AND CORONARY DISEASE (CHD) OR RISK EQUIVALENT TO CHD, ATHEROSCLEROSIS OR RISK OF CHD FROM 10 YEARS OLDER TO 20%.
- Conditions
- -E780 Pure hypercholesterolaemiaPure hypercholesterolaemiaE780
- Registration Number
- PER-073-07
- Lead Sponsor
- ASTRAZENECA - PERU,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Provision of written informed consent
• Male or female patients 18 years of age or older
• A history of CHD or a risk equivalent to CHD, clinical evidence of atherosclerosis (definitions provided in Appendix G) or a 10-year Framingham risk score> 20% for CHD, as described in the NCEP ATP III guidelines
• The patient should have a reasonable possibility of obtaining values of liDL-C> 130 mg / dl up to <220 mg / dl in Visit 2, in the opinion of the Investigator. Based on the experience of previous studies, the following guide can be used to interpret LDL-C results in Visit 1:
-> 125 mg / dl (3.24 mmol / l) up to <220 mg / dl (5.69 mmol / l) in patients without previous treatment with statins (patients who did not perform any therapy for lipid reduction that is known to affect LDL-C in the 4 weeks prior to Visit 1)
-> 90 mg / dl (2.33 mmol / l) up to <180 mg / dl (4.66 mmol / l) in patients taking lovastatin, fluvastatin or pravastatin within 4 weeks of Visit 1
-> 70 mg / dl (1.81 mmol / l) up to <160 mg / dl (4.14 mmol / l) in patients taking simvastatin, atorvastatin, rosuvastatin or any statin in combination with ezetimibe within 4 weeks of Visit 1
• Fasting TG concentration <400 mg / dl (4.52 mmol / 1)
• Patients willing to follow all study procedures including visits to the clinic for scheduled study visits, fasting before clinic visits (all visits with blood draw) and compliance with the treatment regimen in study
• Use of drugs that decrease lipids and other concomitant medications prohibited from Visit 1
• 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 component of ezetimibe.
• Pregnant women, breastfeeding women and women of childbearing age who do not use mechanical or chemical contraceptives or have a positive pregnancy test in serum (analysis of serum p-HCG)
• Patients that the Investigator considers unstable after the following events (event within 8 to 12 weeks of study entry (Visit 1) at the discretion of the Investigator): myocardial infarction, recent episode of unstable angina, myocardial revascularization [surgery] percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (lADC) or any revascularization procedure] or transient ischemic attack (or cerebrovascular accident.) (These patients must be on statin therapy and must not enter a phase of pharmacological rest. {washput), therefore are not suitable for this study)
• Severe congestive heart failure (Class IIIb or IV of the New York Cardiology Association [NYHA]) (see Appendix H). There is no evidence that these patients benefit from statin therapy.
• Patients waiting for myocardial revascularization planned before Visit 1. (These patients require treatment with statins, so a pharmacological resting phase is not appropriate, therefore they are not suitable for this study).
• History of malignant disease with the exception of resected basal or squamous cell carcinoma of the skin. Women with a history of cervical dysplasia will be allowed to enter the study as long as they have 3 consecutive Papanicolaou (Pap) smears without dysplasia. (So as not to include patients who are at risk of recurrence of malignant disease who require treatment)
• History of homozygous familial hypercholesterolemia (the severity of hypercholesterolemia in these patients usually indicates the need for an individualized treatment regimen that may include foresis)
• History of drug or alcohol abuse within the past 5 years
• Current active liver disease [alanine aminotransferase (ALT) (glutamic serum pyruvic transaminase (SGPT))> 2 x normal upper limit (ULN) or severe hepatic impairment j
• Participation in another study with experimental drug (including previous study with rosuvastatin) <4 weeks before enrolling in the study, or in accordance with the requirements of the patient´s local ethics committee stipulating a longer period
• Patients previously selected for this study
• Serious or unstable medical conditions that, in the opinion of the investigator, compromise patient safety or successful participation in the study
• Patients whose hormone replacement therapy (HRT) or treatment; Oral contraceptive (OCT) was initiated or modified within 3 months prior to enrollment in the introduction phase with diet. (Changes in female hormones may have an effect on lipid measurement)
• Patients with uncontrolled hypothyroidism within 3 months prior to enrollment in the introduction phase with diet, defined as TSH> 1.5 x ULN (this is due to the relationship between myopathy and patients with hypothyroidism under treatment with statins)
• Patients with creatine kinase (CK) without explanation within 3 months prior to enrollment in the introduction phase with diet,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The change can be expressed as a percentage change. LDL-C measurement<br>Measure:Change in LDL-C in relation to the basal value.<br>Timepoints:6 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Therapeutic lipid objectives according to what is described in the American and European guidelines with the corresponding measurement of the effect that is the proportion of patients that achieve the objective.<br>Measure:LDL-C, HDL-C, CT, TG, non-HDL-C, ApoB, ApoA-I; CT / HDL-C, LDLC / HDL-C, non-HDL-C / HDL-C and ApoB / ApoA-I, hs-PCR; and the corresponding measurement of the effects are the respective changes from the baseline value<br>Timepoints:12 weeks<br>;<br>Outcome name:An additional sample will be extracted for other possible markers and lipid fractions that are related to atherosclerosis<br>Measure:Change in biomarkers (sitosterol, lanosterol, C4 and LpPLA2).<br>Timepoints:6 weeks<br>