Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients (0653A-172)(COMPLETED) (BRAVO)

Organon

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: ezetimibe (+) simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00654628

2008_010

0653A-172

Details and patient eligibility

About

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

Enrollment: 173 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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173 participants in 1 patient group

1

Experimental group

Description:

Patients with intermediate or high risk dyslipidemia will be enrolled to receive treatment with Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks

Treatment:

Drug: ezetimibe (+) simvastatin