Back to resultsEvaluation of the Effects of Simvastatin 40mg
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK0733
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MK0733,simvastatin
Arm Description
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.
Outcomes
Primary Outcome Measures
Total cholesterol, ldl-c, hdl-c, and triglycerides
Secondary Outcome Measures
Pulse wave velocity
Baroreflex sensitivity
Serum nitrite, nitrate and urine c-gmp levels after 12 weeks treatment
Full Information
NCT ID
NCT00397826
First Posted
November 9, 2006
Last Updated
January 6, 2016
Sponsor
Cardinal Tien Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00397826
Brief Title
Evaluation of the Effects of Simvastatin 40mg
Official Title
Evaluation of the Effects of Simvastatin 40 Mg on Lipid Profiles and Specified Circulatory Parameters in Normotensive Hypercholesterolemia Patients(MK-0733-265)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardinal Tien Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MK0733,simvastatin
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MK0733
Other Intervention Name(s)
simvastatin
Intervention Description
Duration of Treatment: 12 Weeks
Primary Outcome Measure Information:
Title
Total cholesterol, ldl-c, hdl-c, and triglycerides
Time Frame
after 12 weeks treatment
Secondary Outcome Measure Information:
Title
Pulse wave velocity
Time Frame
after 12 weeks
Title
Baroreflex sensitivity
Time Frame
after 12 weeks treatment
Title
Serum nitrite, nitrate and urine c-gmp levels after 12 weeks treatment
Time Frame
after 12 weeks treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Feng Yeih, MD,Phd
Organizational Affiliation
Cardinal Tiem Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of the Effects of Simvastatin 40mg
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