PER-087-04
Completed
未知
A STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COADMINISTRATION OF EZETIMIBE / SIMVASTATIN AND PHENOFIBRATE IN PATIENTS WITH MIXED HYPERLIPIDEMIA
MERCK SHARP & DOHME PERU S.R.L.,0 sites0 target enrollmentFebruary 21, 2005
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient is 18 to 79 years of age.
- •The patient is a post\-menopausal man or woman. The patient is a pre\-menopausal woman who is surgically sterile or who is highly unlikely to conceive, and who has a negative pregnancy test at Visit 1\.
- •The patient will follow a stable diet throughout the study.
- •The patient maintains a stable weight (± 2 kg) for\> 6 weeks before Visit 1\.
- •The patient has a LDL\-C level of 130 to 220 mg / dL (3\.37 to 5\.70 mmol / L) if he / she does not have diabetes; LDL\-C from 100 to 180 mg / dL (2\.59 to 4\.66 mmol / L) if you have diabetes.
- •The patient has a triglyceride level of 150 to 500 mg / dL (1\.71 to 5\.70 mmol / L). \[according to the reference ranges of the central laboratory] in Visit 2\.
- •The patient has a creatine phosphokinase (CPK) level \<2 x the upper limit of normal (ULN) \[according to the reference ranges of the central laboratory] in Visit 2\.
- •The patient has a level of alanine aminotransferase (ALT), and aspartate aminotransferase (AST) \<1\.5 x the upper limit of normal (ULN) \[according to the reference ranges of the central laboratory] in Visit 2\.
Exclusion Criteria
- •The patient has Chronic Class II or IV heart failure as defined by the New York Heart Association (NYHA).
- •The patient has uncontrolled cardiac arrhythmias.
- •The patient has a history of coronary heart disease (CHD), a disease equivalent to CHD, with the exception of diabetes mellitus, \[for example, peripheral arterial disease (femoral, popliteal), abdominal aortic aneurysm, symptomatic carotid artery disease (TIA), stroke)] or risk of CHD\> 20%, as indicated by the National Cholesterol Education Program (NCEP) ATP criteria (Appendix 4 and 5\).
- •The patient has unstable hypertension (systolic blood pressure\> 160 mm Hg or diastolic blood pressure\> 100 mm Hg) at Visit 1\.
- •The patient suffers from hematological, digestive or central nervous system disorders, including a degenerative disease that limits the evaluation or participation in the study.
- •The patient has inadequately controlled diabetes mellitus (HbAlc\> 8\.5%), or has recently been diagnosed (within 3 months), or has had a recent change in antidiabetic pharmacotherapy (ie, a change in dosage \[a exception of ± 10 units of insulin] or the addition of a new medication) within 3 months of Visit 1\.
- •The patient suffers from an uncontrolled endocrine or metabolic disease that is known to influence serum lipids or lipoproteins (ie, secondary causes of hyperlipidemia).
- •The patient suffers from homozygous familial hypercholesterolemia, type I or V hyperlipidemia, or receives an LDL apheresis treatment.
- •The patient has a history of cholelithiasis and has not undergone cholecystectomy.
- •The patient has an active or chronic hepatobiliary or hepatic disease.
Outcomes
Primary Outcomes
Not specified
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