Evaluation of the Effects of Simvastatin 40mg

Study Overview
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Brief Summary
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To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.

Detailed Description
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This is an open-label, prospective study to investigate lipid-lowering efficacy and sympathetic response of normotensive hypercholesterolemia patients after receiving simvastatin 40 mg once daily for 3 months. The total duration of the study will be approximately 13 weeks, comprising of a 1-week (or 4 weeks?) screening period and a 12-week active treatment period. 20 hypercholesterolemia patients with normal blood pressure will be enrolled into treatment group.

Official Title
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Evaluation of the Effects of Simvastatin 40 Mg on Lipid Profiles and Specified Circulatory Parameters in Normotensive Hypercholesterolemia Patients(MK-0733-265)

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: MK0733


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient, >18 years of age Patients with hypercholesterolemia who meet the following lipid criteria: primary cholesterolemia: total cholesterol>=240 mg/dl or ldl-c >= 160 mg/dl secondary cholesterolemia (patients with cad, dm): ldl-c>=130 mg/dl The patient is willing to follow an NCEP therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet throughout the duration of the study Exclusion Criteria: Congestive heart failure (NYHA class III or IV), uncontrolled cardiac arrhythmia, unstable angina Hypertension (based on the atp 3 guidelines) Taking potent lipid-lowering agents Unstable diabetes (hba1c >9%) or newly diagnosed (within 3 months), or a change in anti-diabetes medications within 3 months of screening

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MK0733,simvastatin<br>20 patients with total cholesterol ≧ 240 mg/dL or LDL-C > 160 mg/dL for primary hypercholesterolemia; LDL-C ≧ 130 mg/dL for secondary hypercholesterolemia with identifiable risk factors will be enrolled into study to receive simvastatin 40 mg once daily for 12 weeks. | Drug: MK0733<br>* Duration of Treatment: 12 Weeks<br>* Other names: simvastatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol, ldl-c, hdl-c, and triglycerides |  | after 12 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse wave velocity |  | after 12 weeks | 
| Baroreflex sensitivity |  | after 12 weeks treatment | 
| Serum nitrite, nitrate and urine c-gmp levels after 12 weeks treatment |  | after 12 weeks treatment |