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

NCT ID: NCT00654628

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-01
• Study Completion Date: 2009-07-01

Brief Summary

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

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

ezetimibe (+) simvastatin

Intervention Type: DRUG

Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks.

Interventions

ezetimibe (+) simvastatin

Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks.

Intervention Type: DRUG

Other Intervention Names

Vytorin®; MK653A

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: DERIVED

PMID: 21699369 (View on PubMed)

Other Identifiers

2008_010

Identifier Type: -

Identifier Source: secondary_id

0653A-172

Identifier Type: -

Identifier Source: org_study_id