Trial | NCT00397826  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.
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 Started
Jan 31
2005
Primary Completion
Jan 31
2006
Study Completion
Dec 31
2015
Last Update
Jan 07
2016
Estimate

Drug MK0733

Duration of Treatment: 12 Weeks

  • Other names: simvastatin

MK0733,simvastatin Other

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.

Criteria 

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
No Results Posted