Phase 4
N=173
Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients (0653A-172)(COMPLETED)
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT00654628 ↗Enrolled (actual)
173
Serious AEs
0.6%
Results posted
Aug 2010
Primary outcome: Primary: The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment. — 90.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ezetimibe (+) simvastatin (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment. |
90.4 | — |
| PRIMARY The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 12-week Treatment. |
87.8 | — |
| SECONDARY Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6 |
-51.4 | — |
| SECONDARY Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 6 |
-38.1 | — |
| SECONDARY Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 6 |
4.5 | — |
| SECONDARY Mean Percent Change of Triglycerides From Baseline at Week 6 |
-22.2 | — |
| SECONDARY Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 |
-53.8 | — |
| SECONDARY Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 12 |
-39.5 | — |
| SECONDARY Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 12 |
9.4 | — |
| SECONDARY Mean Percent Change of Triglycerides From Baseline at Week 12 |
-24.7 | — |
Summary
The purpose of this study is to determine the safety and tolerability of ezetimibe/simvastatin in patients newly diagnosed with dyslipidemia.
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
Data sourced from ClinicalTrials.gov (NCT00654628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.