A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, STUDY OF 12 WEEKS OF DURATION TO EVALUATE THE EFFICACY AND SAFETY OF MK-0524B (IN CODMINISTRATION OF DOSES OF MK-0524A AND SIMVASTATIN TABLETS) AGAINST ATORVASTATIN IN PATIENTS WITH HYPERLIPIDEMIA MIXED
- Conditions
- -E78 Disorders of lipoprotein metabolism and other lipidaemiasDisorders of lipoprotein metabolism and other lipidaemiasE78
- Registration Number
- PER-070-08
- 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
- 9
• The patient is male or female> 18 and <80 years old on the day they sign the informed consent.
• Contraceptive methods for potentially fertile female patients: a potentially fertile patient agrees to abstain or use (or have her partner use) 2 acceptable methods of birth control during the course of the study. An acceptable method of birth control is defined as: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy.
• The patient meets the criteria based on the NCEP ATP III rating of the CHD risk) in Visit 2
• Concentrations of triglycerides (TG)> 150 mg / dL to <500 mg / dL (1.7 - 5.6 mmol / L) at Visit 2.
• The patient is pregnant or breastfeeding, or expecting to conceive during the study, including the 14-day follow-up period after the study.
• The patient has a history of malignancy <5 years before signing the informed consent, except for basal cell cancer or squamous cell skin cancer or cervical cancer in situ adequately treated.
• The patient is waiting to donate eggs during the study, including the 14-day follow-up period.
• The patient has a history or concurrent evidence of any condition, therapy, or abnormality of laboratory tests that could confuse the results of the study, interfere with the patient´s participation during the entire course of the study, or not be the most convenient for the patient participates.
• It is unlikely that the patient sticks to the study procedures, respects appointments or is planning to move during the study.
• The patient is currently participating or has participated in a study
• The patient has donated and / or received blood as follows: donated blood products or had a phlebotomy of> 300 mL within 8 weeks prior to signing the informed consent, intended to give or receive blood products during the study, aims to donate more than 250 mL of blood products within 8 weeks after the last study visit.
• The patient has the following laboratory values excluding in Visit 1: Creatinine> 2.0 mg / dL (177 micromol / L), ALT (SGPT)> 1.5xULN, AST (SG0T)> 1.5xULN, CK> 2xULN, abnormal TSH
• The patient has Type 1 or Type 2 diabetes mellitus
• The patient is, at the time of signing the informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse.
• The patient is currently involved, or plans to be involved during the study, in vigorous exercise or an aggressive diet regimen. (See Appendix 6 and Section I.E.4.e) for guidelines and recommendations regarding exercise and diet).
• The patient met <80% with the dose during the placebo transition period AND, in the opinion of the investigator, is believed to be unable to maintain at least 80% compliance with the dose during the active period of administration of the drug. study dose.
• The patient suffers from an uncontrolled endocrine or metabolic disease known to influence lipids or serum lipoproteins (ie, secondary causes of hyperlipidemia, such as hypothyroidism or hyperthyroidism).
• The patient has a nephrotic syndrome or other clinically significant kidney disease.
• The patient suffers from chronic heart failure defined according to Classes III or IV of the New York Cardiology Association (NYHA).
• The patient has suffered from active peptic ulcer within 3 months of Visit 1.
• The patient has had a gout episode within 1 year prior to Visit 1, unless the patient is receiving allopurinol.
• The patient has a history of hypersensitivity or allergic reaction to niacin or to products containing niacin, simvastatin or atorvastatin.
• The patient suffers from uncontrolled / unstable cardiac arrhythmias.
• The patient has a history of myocardial infarction, stroke, coronary bypass surgery or other revascularization procedure, unstable angina or angioplasty within 3 months of Visit 1.
• The patient suffers from unstable hypertension (systolic blood pressure in sitting position> 160 mm Hg or diastolic pressure> 100 mm Hg) at Visit 1. Researchers are encouraged to maximize control of blood pressure in
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method