ClinicalTrials.Veeva

Menu

Evaluation of the Effects of Simvastatin 40mg

C

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)

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems