Evaluation of the Effects of Simvastatin 40mg

NCT00397826 | Completed Phase 4

• 1 other identifier: 0733-265
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Total cholesterol, ldl-c, hdl-c, and triglycerides

  after 12 weeks treatment

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

Drug: MK0733

Interventions

MK0733 DRUG

Duration of Treatment: 12 Weeks

Also known as: simvastatin

MK0733,simvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardinal Tien Hospital: lead

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Dong Feng Yeih, MD,Phd

  Cardinal Tiem Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician of Cardiology

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 10, 2006
• Study Start: January 1, 2005
• Primary Completion: January 1, 2006
• Study Completion: December 1, 2015
• Last Updated: January 7, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share