Evaluation of the Effects of Simvastatin 40mg

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397826
• Other study ID #: 0733-265
• Status: Completed
• Phase: Phase 4
• First received: November 9, 2006
• Last updated: January 6, 2016
• Start date: January 2005
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Cardinal Tien Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: National Bureau of Controlled Drugs
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• MK0733
Duration of Treatment: 12 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cardinal Tien Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cholesterol, ldl-c, hdl-c, and triglycerides		after 12 weeks treatment	No
Secondary	Pulse wave velocity		after 12 weeks	No
Secondary	Baroreflex sensitivity		after 12 weeks treatment	No
Secondary	Serum nitrite, nitrate and urine c-gmp levels after 12 weeks treatment		after 12 weeks treatment	No