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Completed

NCT Number: NCT00654628

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

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

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Key information

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ezetimibe (+) simvastatin

Drug

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

Other names: Vytorin®, MK653A

Primary outcomes

  1. The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment.

    Time frame: Baseline and week 6

    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.

  2. The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 12-week Treatment.

    Time frame: Baseline and week 12

    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.

Secondary outcomes

  1. Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6

    Time frame: Baseline and week 6

  2. Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 6

    Time frame: Baseline and week 6

  3. Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 6

    Time frame: Baseline and week 6

  4. Mean Percent Change of Triglycerides From Baseline at Week 6

    Time frame: Baseline and week 6

  5. Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12

    Time frame: Baseline and week 12

  6. Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 12

    Time frame: Baseline and week 12

  7. Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 12

    Time frame: Baseline and week 12

  8. Mean Percent Change of Triglycerides From Baseline at Week 12

    Time frame: Baseline and week 12

Other outcomes

  1. Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6

    Time frame: Baseline and week 6

  2. Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12

    Time frame: Baseline and week 12

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Acronym: BRAVO

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 8, 2008
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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