Evaluation of the Effects of Simvastatin 40mg

Phase 4

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: MK0733

• Registration Number: NCT00397826
• Lead Sponsor: Cardinal Tien Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2006-01
• Study First Submitted: 2006-11-09
• Study First Submitted QC: 2006-11-09
• Study First Posted: 2006-11-10
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MK0733,simvastatin	MK0733	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.

Primary Outcome Measures

Name	Time	Method
Total cholesterol, ldl-c, hdl-c, and triglycerides	after 12 weeks treatment

Secondary Outcome Measures

Name	Time	Method
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