Status:
COMPLETED
Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients (0653A-172)(COMPLETED)
Lead Sponsor:
Organon and Co
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
20-79 years
Phase:
PHASE4
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
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT00654628
Start Date
August 1 2007
End Date
July 1 2009
Last Update
May 22 2024
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