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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00397826

Enrollment

Registered

2006-11-10

Start date

2005-01-31

Completion date

2015-12-31

Last updated

2016-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

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.

Interventions

DRUGMK0733

Duration of Treatment: 12 Weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Total cholesterol, ldl-c, hdl-c, and triglycerides	after 12 weeks treatment

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026