Evaluation of the Effects of Simvastatin 40mg

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2015-12-31

Brief Summary

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

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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.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MK0733,simvastatin

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.

Group Type OTHER

MK0733

Intervention Type DRUG

Duration of Treatment: 12 Weeks

Interventions

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MK0733

Duration of Treatment: 12 Weeks

Intervention Type DRUG

Other Intervention Names

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simvastatin

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:

1. primary cholesterolemia: total cholesterol\>=240 mg/dl or ldl-c \>= 160 mg/dl
2. 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No