.A.
- Conditions
- -E78 Disorders of lipoprotein metabolism and other lipidaemiasDisorders of lipoprotein metabolism and other lipidaemiasE78
- Registration Number
- PER-001-97
- 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
a. Coronary heart disease (CHD) and/or atherosclerotic disease (AD) with LDL>130 mg/dL (>3.4 mmol/L); or >2 risk factors for CHD without CHD and/or AD but LDL>160 mg/dL (>4.16 mmol/L); or without CHD and/or AD and <2 risk factors but LDL>190mg/dL (>4.9 mmol/L) at Visit 2 (Week -1).
b. Triglycerides >350mg/dL (>3.95 mmol/L) at Visit 2 (Week -1).
c. Liver transaminases (ALT, AST) with values not exceeding 10% of the normal upper limit (NUL) or CK values not exceeding 50% of the NUL without an obvious etiology in Visit 2 (Week -1).
d. Ages 21 to 70.
e. Alcohol consumption <10 drinks per week.
F. Men or women. Pre-menopausal women, unless they are surgically sterilized or have a high possibility of not conceiving. Highly Unlikely to conceive is defined as a woman who takes oral contraceptives or who have had an IUD for> 3 months without complaint.
a. Type I, III, IV or V hyperlipidemia or familial hypercholesterolemia.
b. Treatment for lipid reduction including bile acid chelators, HMG-CoA reductase inhibitors and nicotinic acid (6 prior weeks) and fibrates (8 prior weeks), or probucol in a year period before selection (Visit 1, Week -4).
c. Any systemic immunosuppressant medication including cyclosporine; systemic azole antifungal agent including itraconazole and ketoconazole; erythromycin or clarithromycin; cisapride; H-1 blockers, terfenadine, astemizole, and nefazodone.
d. Therapy with warfarin or anticoagulants similar to warfarin.
e. Renal impairment defined by serum creatinine>1.8 mg/dL (>179pmol/L).
f. Active liver disease.
g. Acute coronary insufficiency (e.g., unstable angina or an intermediate syndrome); vasospastic angina (Prinzmetal).
h. Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary pacemaker surgery or infarction in the previous three months.
i. Uncontrolled hypertension (treated or not) with systolic blood pressure >160mmHg or diastolic >100 Hg.
j. Secondary hypercholesterolemia to hypothyroidism (T4 <4ug/dL and TSH>10ug/mL, measured at Visit 1, Week -4) or nephrotic syndrome.
k. Patients with Type 1 or Type 2 diabetes mellitus with HbA1c> 10% at Visit 1, Week -4.
I. Partial ileal anastomosis.
m. Weight 50% above the ideal body weight, according to the Metropolitan Tables of Weights and Heights of 1983.
n. Hypersensitivity to HMG-CoA reductase inhibitors.
o. Any other condition or therapy that, in the opinion of the investigator, may constitute a risk to the patient or may alter the results of the study.
p. Poor mental functions or any other reason for which the patient is believed to have problems to provide informed consent or to comply with the requirements demanded by the study.
q. Treatment with any other investigational medication within 30 days before the baseline.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Relative potency of a diet plan and simvastatin of 40-80 mg/day or atorvastatin 20-40 mg/day in the LDL and triglycerides levels.<br>Measure:Primary efficacy parameter<br>Timepoints:Weeks -2, -1, 1, and 12.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Relative potency of a diet plan and simvastatin of 40-80 mg/day or atorvastatin 20-40 mg/day in the triglycerides levels.<br>Measure:Secondary efficacy parameter<br>Timepoints:Weeks -2, -1, 1, and 12.<br>;<br>Outcome name:Relative potency of a diet plan and simvastatin of 40-80 mg/day or atorvastatin 20-40 mg/day in the HDL and VLDL levels.<br>Measure:Secondary efficacy parameter<br>Timepoints:Weeks -2, -1, 1, and 12.<br>;<br>Outcome name:Frequency and intensity of adverse events (clinical and laboratory).<br>Measure:Secondary safety parameter<br>Timepoints:Throughout the study.<br>