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Completed

NCT Number: NCT00397826

Evaluation of the Effects of Simvastatin 40mg

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0733

Drug

Duration of Treatment: 12 Weeks

Other names: simvastatin

Primary outcomes

  1. Total cholesterol, ldl-c, hdl-c, and triglycerides

    Time frame: after 12 weeks treatment

Secondary outcomes

  1. Pulse wave velocity

    Time frame: after 12 weeks

  2. Baroreflex sensitivity

    Time frame: after 12 weeks treatment

  3. Serum nitrite, nitrate and urine c-gmp levels after 12 weeks treatment

    Time frame: after 12 weeks treatment

Sponsors and collaborators

Lead sponsor

Cardinal Tien Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2015
First posted
Nov 10, 2006
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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