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

Hypercholesterolemia Clinical Trial

— BRAVO  

Official title:

Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654628
• Other study ID #: 0653A-172
• Secondary ID: 2008_010
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2007
• Est. completion date: July 1, 2009

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: July 1, 2009
• Est. primary completion date: July 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia

Intervention

Drug:
• ezetimibe (+) simvastatin
Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6		Baseline and week 6
Other	Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12		Baseline and week 12
Primary	The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment.	Goal attainment percentage of LDL-C after 6-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level >130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol >200 mg/dl or LDL-C level >130 mg/dl.	Baseline and week 6
Primary	The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 12-week Treatment.	Goal attainment percentage of LDL-C after 12-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level >130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol >200 mg/dl or LDL-C level >130 mg/dl.	Baseline and week 12
Secondary	Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6		Baseline and week 6
Secondary	Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 6		Baseline and week 6
Secondary	Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 6		Baseline and week 6
Secondary	Mean Percent Change of Triglycerides From Baseline at Week 6		Baseline and week 6
Secondary	Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12		Baseline and week 12
Secondary	Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 12		Baseline and week 12
Secondary	Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 12		Baseline and week 12
Secondary	Mean Percent Change of Triglycerides From Baseline at Week 12		Baseline and week 12