Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)
- Conditions
- -E888 Other specified metabolic disordersOther specified metabolic disordersE888
- Registration Number
- PER-019-07
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. The patient understands the study procedures, alternative treatments available and the risks involved in the study, and voluntarily agrees to participate by providing written consent.
2. The patient is a man or woman ≥ 18 and ≤ 79 years of age within 30 days of signing the informed consent.
3. A patient who is potentially fertile and agrees to practice abstinence or use 2 acceptable contraceptive methods within the projected duration of the study.
4. Patients who are receiving non-cyclical hormonal therapy if they are kept at a stable dose and regimen for a minimum of 8 weeks before Visit 1 and if they are willing to continue with the same regimen throughout the study.
5. The patient is willing to maintain a cholesterol-lowering diet throughout the study.
6. The patient has not taken agents that alter lipids.
7. The patient presents a diagnosis of metabolic syndrome.
8. Patients with a baseline LDL-C level as defined below: a) Those with established coronary heart disease and other atherosclerotic vascular disease will have an LDL-C ≥ 70 mg / dL. b) Those without atherosclerotic vascular disease who have diabetes or multiple risk factors and a 10-year risk level of CHD> 20% will have an LDL-C ≥ 100 mg / dL.
1. The patient presents values of exclusionary laboratories in Visit 1.
2. Patients weighing <100 Ib (45 kg).
3. The patient has hypersensitivity or intolerance to ezetimibe, or to the combination tablet of ezetimibe / simvastatin.
4. The patient has hypersensitivity or intolerance to atorvastatin.
5. The patient consumes more than 2 alcoholic drinks a day.
6. The patient is pregnant or nursing, or expects to become pregnant within the projected duration of the study.
7. 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.
8. The patient presents a current history or 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 more convenient for the patient to participate in it.
9. The patient suffers from Class III or IV congestive heart failure.
10. The patient has uncontrolled cardiac arrhythmias or recent significant changes in his electrocardiogram (ECG).
11. The patient presents unstable angina pectoris.
12. The patient has had a myocardial infarction, coronary artery bypass surgery with graft, or angioplasty within 3 months of Visit 1.
13. The patient has had a partial ileal bypass, gastric bypass, or other significant condition associated with insufficient absorption.
14. The patient has an unstable or severe peripheral arterial disease within 3 months of Visit 1.
15. The patient has uncontrolled hypertension and systolic blood pressure> 160 mm Hg or diastolic blood pressure> 100 mm Hg at Visit 1.
16. The patient suffers from poorly controlled or recently diagnosed Type 1 or Type 2 diabetes mellitus.
17. The patient presents disorders of the hematological system, digestive system or central nervous system including a cerebrovascular disease and a degenerative disease that could limit the evaluation or participation in the study.
18. The patient has an uncontrolled endocrine or metabolic disease that is known to influence lipids or serum lipoproteins.
19. The patient presents a positive diagnosis for the human immunodeficiency virus (HIV).
20. The patient presents a history of malignancy ≤ 5 years before signing the informed consent.
21. The patient is, at the time of signing the informed consent, a user of recreational or illicit drugs or has had a recent history of drug addiction or alcoholism or dependence on drugs or alcohol.
22. The patient has a history of mental instability or inadequately controlled major psychiatric illness and stable pharmacotherapy.
23. The patient is currently taking drugs that are potent inhibitors of cytochrome P-450 3A4. Drugs that increase the risk of myopathy will also be banned.
24. The patient consumes> 1 quart of grapefruit juice per day.
25. The patient is receiving treatment with systemic corticosteroids.
26. Patients are currently taking psyllium, other fiber-based laxatives, and / or non-prescription (OTC) therapies that are known to affect serum lipids, phytosterol margarines, unless they are treated with a stable regimen for a minimum 6 weeks before Visit 2 and the patient agrees to stay on a constant diet throughout the study.
27. The patient is taking any cyclic hormone.
28. The patient is
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Serum levels of LDL-C after 12 hours after the last meal / food / drink intake except for water.<br>Measure:Percentage change with respect to the baseline in the LDL-C.<br>Timepoints:At 6 weeks of treatment.<br>
- Secondary Outcome Measures
Name Time Method