Clinical trial NCT00654628: Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients (0653A-172)(COMPLETED)
Official title: Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-04-08
Enrollment: 173
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of ezetimibe/simvastatin in patients newly diagnosed with dyslipidemia.


Eligibility criteria: Inclusion Criteria:

* Male Or Female Patient, 20 Through 79 Years Of Age
* Newly Diagnosed Dyslipidemia Patients Including: 1) Intermediate Risk (\>2 Risk Factors) With Total Cholesterol level above 200 mg/dL Or Low Density Lipoprotein-C (LDL-C) level\> 130 mg/dLwho failed a 3-Month diet control period, or 2) High Risk Patients with history of Coronary artery disease Or diabetes and having a total Cholesterol\> 200 mg/dL Or LDL-C level\> 130 mg/dL
* Willing To Follow An National Cholesterol Education Program (NCEP) Therapeutic Lifestyle Changes (TLC) Or Similar Cholesterol-Lowering Diet For The Duration Of The Study
* Female Patients Receiving Hormone Therapy (Including Hormone Replacement Therapy, And Estrogen Antagonist/Agonist, Or Oral Contraceptives) If Maintained On A Stable Dose And Regimen For At Least 8 Weeks Prior To Visit 1 And If Willing To Continue The Same Regimen Throughout The Study

Exclusion Criteria:

* Women Who Are Pregnant Or Lactating
* Has A History Of Cancer Within The Past 5 Years (Except For Dermatological Basal Cell Or Squamous Cell Carcinoma)
* Patients Hypersensitive To Simvastatin Or Ezetimibe
* Any Condition Or Situation Which, In The Opinion Of The Investigator, Might Pose A Risk To The Patient Or Confound The Results Of The Study
* History Of Mental Instability, Drug/Alcohol Abuse Within The Past 5 Years, Or Major Psychiatric Illness Not Adequately Controlled By Pharmacotherapy
* Nephritic Syndrome Or Other Clinically Significant Renal Disease Resulting In Impaired Renal Function, Defined As Serum Creatinine ≧ 1.5 Mg/Dl
* Alanine Aminotransferase (ALT), And Aspartate Aminotransferase (AST) above 1.5 X Upper Limit Of Normal (Uln) Or With Active Liver Disease
* Congestive Heart Failure (New York Heart Association (NYHA) III Or IV), Uncontrolled Cardiac Arrythmias, Uncontrolled Hypertension (Systolic Blood Pressure (SBP) \>160 mm Hg Or Diastolic Blood Pressure (DBP) \>100 mm Hg), Unstable Angina Pectoris Or Severe Peripheral Artery Disease, Or Experienced Myocardial Infarction, Coronary Artery Bypass Surgery, Angioplasty Within 3 Months
* Unstable Diabetes Mellitus Patient (Hemoglobin A1c (HbA1c) \> 8.5%) Or Newly Diagnosed (Within 3 Months) Or A Change In Anti-Diabetic Pharmacotherapy Within 3 Months Of Screening
* Secondary Dyslipidemia (E.G., Hypothyroidism)
* Disorders Of The Hematologic, Digestive, Or Central Nervous Systems Including Cerebrovascular Disease And Degenerative Disease That Would Limit Study Evaluation Or Participation
* History Of Active Or Chronic Hepatobiliary Disease Or Cholelithiasis But Have Not Undergone Cholecystectomy

Primary outcomes:
measure: The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment.
timeFrame: Baseline and week 6
measure: The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 12-week Treatment.
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6
timeFrame: Baseline and week 6
measure: Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 6
timeFrame: Baseline and week 6
measure: Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 6
timeFrame: Baseline and week 6
measure: Mean Percent Change of Triglycerides From Baseline at Week 6
timeFrame: Baseline and week 6
measure: Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12
timeFrame: Baseline and week 12
measure: Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 12
timeFrame: Baseline and week 12
measure: Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 12
timeFrame: Baseline and week 12
measure: Mean Percent Change of Triglycerides From Baseline at Week 12
timeFrame: Baseline and week 12
Other outcomes:
measure: Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6
timeFrame: Baseline and week 6
measure: Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12
timeFrame: Baseline and week 12
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Huang JC, Lee TY, Liou MJ, Lin CM, Pei D, Chen ZC, Liu RT, Kwok CF. Begin with the real-world patients of non-goal-achieved hypercholesterolemia in taiwan through the ezetimibe/simvastatin tablet - The BRAVO Study. Curr Med Res Opin. 2011 Aug;27(8):1645-51. doi: 10.1185/03007995.2011.594425. Epub 2011 Jun 23.