A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL, 12 WEEKS OF DURATION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF THE COMBINATION TABLET OF EZETIMIBE / SIMVASTATIN AGAINST ATORVASTATIN IN PATIENTS WITH MAJOR ADULTS WITH HYPERCHOLESTEROLEMIA AT HIGH AND MODERATELY HIGH RISK OF ACQUIRING A CORONARY CARDIOPATHY

Not Applicable

• Conditions: -I95-I99 Other and unspecified disorders of circulatory system-E780 Pure hypercholesterolaemia; Pure hypercholesterolaemia; Other and unspecified disorders of circulatory system; E780; I95; I99

• Registration Number: PER-072-07
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• The patient understands the study procedures, alternative treatments available and the risks involved with the study, and voluntarily agrees to participate by providing written informed consent.
• The patient is a male or postmenopausal woman and is> 65 years old on the day of signing the informed consent.
• The patient is willing to maintain a diet with Therapeutic Changes in Lifestyle according to the NCEP (TLC) / ADA guidelines or similar cholesterol reduction diet throughout the study.
• Patients who are receiving non-cyclic hormone therapy (including non-clinical hormone replacement therapy or any estrogen antagonist / agonist) that have been maintained at a stable dose and regimen for at least 8 weeks prior to Visit 1 (Week - 3) and are willing to continue with the same regimen throughout the study.
• The patient meets one of the following criteria: Patients without previous contact with therapy who are at high risk of acquiring a CHD with coronary heart disease and other established atherosclerotic vascular disease or,
• -It is defined without previous contact with the therapy as not having been treated with a lipid reducing agent within 6 weeks (8 weeks if it is a fibrate) before Visit 2 (Week -1).
- Patients without previous contact with the therapy who are at high risk of acquiring a CHD without atherosclerotic vascular disease who have diabetes or,
- Patients without previous contact with the drug who are at high risk of acquiring a CHD without atherosclerotic vascular disease or diabetes with> 2 risk factors and a 10-year risk for CHD> 20% (determined by the Framingham calculation, see Appendix 6.4) or,
- Patients without previous contact with the drug or who are considered without previous contact with the drug through appropriate prior pharmacological rest, who are at moderately high risk of acquiring a CHD with> 2 risk factors and a 10-year risk for CHD of 10-20% (determined by the Framingham calculation, see Appendix 6.4).
• The patient has a baseline LDL-C level of> 130 mg / dL (3.36 mmol / L) at Visit 2 (Week -1).

Exclusion Criteria

• The patient weighs <100 Ibs (45 kg).
• The patient has hypersensitivity or intolerance to ezetimibe, simvastatin or atorvastatin or any component of these drugs, or has a history of myopathy or significant rhabdomyolysis with ezetimibe or any statin.
• The patient routinely consumes more than 2 alcoholic beverages per day.
• The patient is currently participating or has participated in a study with a compound or device under investigation within 30 days of signing the informed consent.
• The patient has taken torcetrapib alone or in combination and the last dose was administered within 1 year of Visit 1.
• The patient has excluding laboratory values ​​in Visit 1 (Week -3)
• The patient´s triglycerides (TG) are> 350 mg / dL (3.95 mmol / L) at Visit 2.
• The patient has an uncontrolled endocrine or metabolic disease that is known to influence lipids or serum lipoproteins (ie, secondary causes of hyperlipidemia, such as hypothyroidism or hyperthyroidism).
• Note: A patient with hyperthyroidism or hypothyroidism is defined as a patient with a TSH value below the lower limit of the normal reference range of the central laboratory or> 20% above the upper limit of the normal reference range in the Visit 1. For patients receiving thyroid hormone, there is no lower TSH threshold for entry into the study and the patient must be under a stable dose for> 6 weeks before the randomization visit. For patients whose TSH value is above the study entry criteria, thyroid hormone therapy should be adjusted or initiated as long as there is time to stabilize the patient and the patient still meets the enrollment deadlines. A review will be allowed if the original TSH value is less than 40% above or below the reference range, as long as the patient still meets the criteria after the review.
• The patient has history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that could confuse the results of the study, or interfere with the patient´s participation throughout the duration of the study, not being the most convenient for the patient participate in it.
• The patient suffers from congestive heart failure defined by NYHA Class III or IV (New York Heart Association).
• The patient has unstable angina pectoris.
• The patient has had a myocardial infarction, coronary artery bypass surgery, angioplasty, or uncontrolled or severe peripheral arterial disease within 3 months of Visit 1 (Week -3).
• The patient has had a partial iliac bypass, gastric bypass, or other significant condition associated with intestinal malabsorption.
• The patient has uncontrolled hypertension (treated or untreated) and systolic blood pressure> 160 mm Hg or diastolic blood pressure> 100 mm Hg at Visit 1 (Week -3). Researchers are encouraged to optimize blood pressure control according to current guidelines before randomization.
• The patient has an estimated glomerular filtration rate (eGFR) <30 mL / min / 1.73 m based on the MDRD equation of 4 variables (Modification of the Diet in Renal Disease) in Visit 1 (done by the central laboratory), Nephrotic syndrome or other clinically significant kidney disease at Visit 1 (Week -3).
• The patient has an uncontrolled endocrine or metabolic disease that is known to influence lipids or serum lipoproteins (ie, secondary causes of hyperlipidemia), such as Cushing´s syndrome at Visit 1 (Week -3).
• The patient has type 2

Study & Design

• Study Type: Interventional
• Study Design: Not specified