Evaluation of the Effects of Simvastatin 40mg on Lipid Profiles and Cardiac Function and Structures in Hypercholesterolemia Patients

This study has been completed.

First Received: November 9, 2006 Last Updated: February 2, 2007 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00397826

Purpose

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

Condition	Intervention	Phase
Hypercholesterolemia	Drug: MK0733, simvastatin / Duration of Treatment: 12 Weeks	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the Effects of Simvastatin 40 Mg on Lipid Profiles and Specified Circulatory Parameters in Normotensive Hypercholesterolemia Patients

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Lipids Simvastatin

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Total cholesterol, ldl-c, hdl-c, and triglycerides after 12 weeks

Secondary Outcome Measures:

Pulse wave velocity
Baroreflex sensitivity
Serum nitrite, nitrate and urine c-gmp levels after 12 weeks treatment

Estimated Enrollment:	20
Study Start Date:	January 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397826

Locations

Taiwan
Merck Sharp & Dohme (I.A.) Corp.
Taipei, Taiwan, 106

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Study ID Numbers:	2006_045
Study First Received:	November 9, 2006
Last Updated:	February 2, 2007
ClinicalTrials.gov Identifier:	NCT00397826 History of Changes
Health Authority:	Taiwan: National Bureau of Controlled Drugs

Study placed in the following topic categories:

Antimetabolites
Metabolic Diseases
Hyperlipidemias
Simvastatin
Antilipemic Agents
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolic Disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 01, 2009