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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00654628
First received: April 2, 2008
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Hypercholesterolemia
Drug: ezetimibe (+) simvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment. [ Time Frame: Baseline and week 6 ] [ Designated as safety issue: No ]
    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.

  • The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 12-week Treatment. [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6 [ Time Frame: Baseline and week 6 ] [ Designated as safety issue: No ]
  • Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 6 [ Time Frame: Baseline and week 6 ] [ Designated as safety issue: No ]
  • Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 6 [ Time Frame: Baseline and week 6 ] [ Designated as safety issue: No ]
  • Mean Percent Change of Triglycerides From Baseline at Week 6 [ Time Frame: Baseline and week 6 ] [ Designated as safety issue: No ]
  • Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
  • Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
  • Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
  • Mean Percent Change of Triglycerides From Baseline at Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6 [ Time Frame: Baseline and week 6 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]

Enrollment: 173
Study Start Date: August 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: ezetimibe (+) simvastatin
Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks.
Other Names:
  • Vytorin®
  • MK653A

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654628

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00654628     History of Changes
Other Study ID Numbers: 0653A-172, 2008_010
Study First Received: April 2, 2008
Results First Received: July 30, 2010
Last Updated: October 25, 2013
Health Authority: Taiwan: National Bureau of Controlled Drugs

Additional relevant MeSH terms:
Dyslipidemias
Hypercholesterolemia
Lipid Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Simvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014