Evaluation of the Effects of Simvastatin 40mg

Cardinal Tien Hospital

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: MK0733

Study type: Interventional

Funder types: Other

Identifiers

NCT00397826

0733-265

Details and patient eligibility

About

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

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

MK0733,simvastatin

Other group

Description:

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.

Treatment:

Drug: MK0733