Clinical trial NCT00664469 (phase 3, status: terminated)
Conditions: hypercholesterolemia
ICD codes: E78.01, E78.00, Z83.42
Drugs: ezetimibe, comparator: simvastatin 20, 40 and 80 mg, comparator: atorvastatin, comparator: rosuvastatin
SMILES: CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1, CC1=CC(O)=CC(C)=C1Cl, CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1, CC(C)C1=NC(=NC(C2=CC=C(F)C=C2)=C1\C=C\[C@@H](O)C[C@@H](O)CC(=O)O)N(C)S(C)(=O)=O
Reason stopped: 
    poor enrollment
  
Eligibility criteria:

        Inclusion Criteria:

          -  According To The Judgment Of The Treating Physician, Changing Of The Current Regimen
             Or Doubling Of The Current Statin Dose Would Be Indicated For The Management Of The
             Patients Hypercholesterolemia

          -  All Women Of Childbearing Potential Must Be Practicing An Effective Method Of
             Contraception Beginning At Least Seven (7) Days Prior To The Study And Continuing At
             Least 14 Days After Study Completion Or After Study Discontinuation All Women Of
             Childbearing Potential Must Be Practicing An Effective Method Of Contraception
             Beginning At Least Seven (7) Days Prior To The Study And Continuing At Least 14 Days
             After Study Completion Or After Study Discontinuation

          -  Patient Is Male Or Female >= 18 Years Of Age

          -  Patient Is Of South Asian Descent, Specifically Canadian Citizens Or Landed Immigrants
             With Ethnic Background From India, Pakistan, Nepal, Bangladesh Or Sri Lanka.

          -  Patients With A Diagnosis Of Primary Hypercholesterolemia And Who Are Defined As Being
             "High Risk" With A Diagnosis Of Cad Or Diabetes, Either By Past Medical History Or By
             Angiographic Or Laboratory Evidence

          -  The Patient Has Serum Ldl-C > 2.0 Mmol/L While On Any Statin At Below Maximum (10 Mg,
             20 Mg Or 40 Mg/Day) Daily Dose For A Minimum Of Four Weeks Prior To The Baseline Visit

        Exclusion Criteria:

          -  Any Condition Which, In The Opinion Of The Investigator, Would Be Likely To Render The
             Patient Unable To Complete The Study Or For Which Study Participation Would Produce
             Significant Risk Or Not Be In The Best Interests Of The Patient

          -  Cancer Within The Past 5 Years (Except For Successfully Treated Basal And Squamous
             Cell Carcinoma)

          -  Disorders Of The Hematologic, Digestive (Including Malabsorptive Disorders), Or
             Central Nervous System Including Cerebrovascular Disease And Degenerative Diseases
             That Would Limit Study Evaluation Or Participation

          -  Doubling Of The Current Statin Dose Is Not Possible Due To Tolerability Or Safety
             Concerns Or Because The Patient Is Already On The Maximum Statin Dose (C.F. Individual
             Statin Monograph)

          -  Female Patient Receiving Hormone Therapy Not On A Stable Dose And Regimen For At Least
             8 Weeks Prior To Visit 1 Or Is Unwilling To Continue The Same Regimen Throughout The
             Study

          -  History Of Mental Instability, Drug/Alcohol Abuse Within The Past 5 Years, Or Major
             Psychiatric Illness Not Adequately Controlled And Stable On Pharmacotherapy

          -  Individuals With Poor Mental Function, Drug Or Substance Abuse, Or Individuals With
             Unstable Psychiatric Illnesses, Which, In The Opinion Of The Investigator, May
             Interfere With Optimal Participation In The Study. Alcoholic Substance Abuse Would Be
             Defined As A Patient With Alcohol Consumption > 14 Drink Per Week. (A Drink Is: A Can
             Of Beer, Glass Of Wine, Or Single Measure Of Spirits)

          -  Medications That Are Potent Inhibitors Of Cyp3a4, Including Cyclosporin, Systemic
             Itraconazole Or Ketoconazole, Erythromycin, Telithromycin Or Clarithromycin,
             Nefazodone, Protease Inhibitors. In Addition, Patients Should Not Take Amiodarone,
             Verapamil, Or Danazol. Patient Is Consuming > 950ml (> 1 Quart) Of Grapefruit
             Juice/Day

          -  Non-Statin Lipid-Lowering Agents Including Fish Oils, Cholestin, Bile Acid
             Sequestrants, And Niacin (>200 Mg/Day) Taken Within 6 Weeks And Fibrates Within 8
             Weeks Prior To Randomization At Visit 2 (Day 1)

          -  Oral Corticosteroids (Unless Used As Replacement Therapy For Pituitary/Adrenal Disease
             And On A Stable Regimen For At Least 6 Weeks Prior To Visit 1).

          -  Patient Has Liver Transaminases (Alt, Ast) > 50% Above The Upper Limit Of Normal At
             Screening (Visit 1) Or Active Liver Disease, And/Or Creatine Kinase (Ck) >50% Above
             The Upper Limit Of Normal (ULN)

          -  Patient Who Is Known Hiv Positive

          -  Patients Taking A Statin Medication Requiring Or Likely To Require Treatment With
             Prohibited Agents: Those With Known Interactions With Statins Including Antifungal
             Azoles (Itraconazole And Ketoconazole), Macrolide Antibiotics (Erythromycin And
             Clarithromycin), Nefazodone And Protease Inhibitors, Amiodarone And Verapamil

          -  Patients That Are Treatment Naive For Statins

          -  Patients Who Have Been Treated With Any Other Investigational Drug Within 30 Days
             Prior To Visit 1. (If < 30 Days, Contact The Clinical Monitor For A Case-By-Case
             Evaluation.)

          -  Serum Creatinine >2.0 Mg/Dl Or 177 Micromol/L At Screening Visit (Visit 1), Or Active
             Renal Disease With Significant Proteinuria (>1 Mg Albumin/Mg Creatinine), Or Nephrotic
             Syndrome At Visit 1

          -  Uncontrolled Endocrine Or Metabolic Disease Known To Influence Serum Lipids Or
             Lipoproteins (I.E. Secondary Causes Of Hyperlipidemia) Or Secondary
             Hypercholesterolemia Due To Hypothyroidism [T4 < 51.48nmol/L (< 4 Microg/Dl)] At Visit
             1

          -  Use Of Therapeutic Doses Of Corticosteroids For Conditions Which, In The Opinion Of
             The Investigator, Are Likely To Require The Use Of Therapeutic Corticosteroid Therapy
             During The Subjects Period Of Participation In The Study