MK-0524B Lipid Study
- Conditions
- -E780 Pure hypercholesterolaemia-E782 Mixed hyperlipidaemiaPure hypercholesterolaemiaMixed hyperlipidaemiaE780E782
- Registration Number
- PER-045-07
- 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 is a man or a woman ≥ 18 and ≤ 85 years of age.
2. Contraception for potentially fertile female patients: A potentially fertile female patient agrees to remain abstinent or to use 2 acceptable methods of contraception throughout the study.
3. The patient presents with primary hypercholesterolemia or mixed dyslipidemia.
4. The patient´s glycemic status has been determined before Visit 2.
5. The patient meets one of the following triglyceride (TG) criteria: a) The patient is receiving niacin, statin or fibrate and has TG <500 mg / dL on or within 6 months of drug rest. b) The patient is not receiving any lipid-modifying therapy or is on lipid-modifying therapy other than niacin, statin or fibrate and has TG <600 mg / dL on or within 6 months of selection.
1. The patient is pregnant or breastfeeding or expecting to conceive during the study, including 14 days post-study follow-up.
2. The patient has a history of malignancy of ≤ 5 years before signing the informed consent.
3. The female patient is waiting to donate eggs during the study, including the 14-day follow-up.
4. The patient has a history or current evidence of any condition, therapy or abnormality of the laboratory that could confuse the results of the study, interfere with the patient´s participation during the entire course of the study, or it is not convenient for the patient to participate in the study.
5. The patient consumes more than 2 alcoholic drinks per day.
6. The patient is unlikely to comply with study procedures, keep appointments, or plan to move during the study.
7. The patient has taken torcetrapib alone or in combination and the last dose was administered within 1 year of Visit 1.
8 The patient is currently participating in a study or has participated in a study with: a) A research compound within 30 days of randomization. b) A lipid modifying compound, different from the fibrate within 6 weeks of randomization. c) A fibrate within 8 weeks of randomization.
9. The patient has donated and / or received blood.
10. The patient presents laboratory exclusion values.
11. Patient with Type 1 or Type 2 diabetes mellitus and: a) Receiving statin therapy. b) Poorly controlled. c) Recently diagnosed. d) Recently experienced repeated hypoglycaemia or unstable glycemic control. e) Receiving new or recently adjusted antidiabetic pharmacotherapy within 3 months of Visit 1.
12. The patient is a user of recreational or illicit drugs or has a recent history of drug or alcohol abuse.
13. The patient is at high risk and is receiving a statin.
14. The patient is receiving doses of a statin with efficacy in the decrease of LDL-C equivalent or higher than that of 80 mg of simvastatin.
15. The patient currently performing or during the study plans to perform strenuous exercise or an aggressive diet regimen.
16. The patient had a compliance <80% with the dosage during the transition period of placebo.
17. The patient has hyperthyroidism or hypothyroidism.
18. The patient has nephrotic syndrome or other clinically significant kidney disease.
19. The patient has chronic heart failure.
20. The patient has had an active peptic ulcer in ≤ 3 months of Visit 1.
21. The patient has had a gout episode within 1 year of Visit 1, and is not receiving allopurinol.
22. The patient has a history of hypersensitivity to niacin, simvastatin, or products containing niacin.
23. The patient presents uncontrolled / unstable cardiac arrhythmias.
24. The patient has a history of myocardial infarction, stroke, coronary artery bypass surgery or other revascularization procedure, unstable angina or angioplasty within 3 months of Visit 1.
25. The patient presents uncontrolled hypertension.
26. The patient has a history of ileal bypass, gastric bypass, or other history of a significant condition associated with malabsorption.
27. The patient has hepatobiliary disease or active or chronic liver disease.
28. The patient is HIV positive.
29. The patient has taken niacin, bile acid sequestrants, HMG-CoA reductase inhibitors, ezetimibe, CHOLESTIN and other red yeast products within 6 weeks or fibrates within 8 weeks of Visit 2.
30. The pat
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Serum level of Low Density Lipoprotein (LDL-C).<br>Measure:Percentage change from baseline to end of treatment period in LDL-C.<br>Timepoints:Week 8.<br>
- Secondary Outcome Measures
Name Time Method