Status:
TERMINATED
INdians Followed for INtensive Lipid Lowering Treatment and Its safetY
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Merck Frosst Canada Ltd.
Schering-Plough
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In South Asian Canadians with documented coronary artery disease or diabetes and hypercholesterolemia with LDL-C levels \> 2.0 mmol/L after 4 weeks of monotherapy with any statin: To compare the perce...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00664469
Start Date
August 1 2007
End Date
November 1 2010
Last Update
July 28 2011
Active Locations (1)
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1
Merck Frosst Canada Ltd.
Kirkland, Quebec, Canada, H9H 3L1