Phase
Condition
Hypercholesterolemia
Atherosclerosis
Chest Pain
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female patient's ≥ 18 years of age with or without documented coronary arterydisease
Women of child-bearing potential, that is, women not surgically sterilized and betweenmenarche and 1 year post menopause, must test negative for pregnancy at the time ofenrollment based on a serum pregnancy test and agree to use a reliable method of birthcontrol (for example, use of oral contraceptives or levonorgestrel); or a reliablebarrier method of birth control (diaphragms with contraceptive jelly; cervical capswith contraceptive jelly; condoms with contraceptive foam; intrauterine devices;partner with vasectomy; or abstinence) during the study and for one month followingthe last dose of study drug.
HDL-C requirements. Current (Local lab within 60 days or central lab results prior toVisit 1): HDL-C of ≤45 mg/dL (1.17 mmol/L) for females, and HDL-C of ≤40 mg/dL (1.04mmol/L) for males
Taking statin therapy for at least 30 days prior to screening (Visit 1), and in theinvestigators opinion, an unlikely need for statin dose adjustment during the courseof the study.
In the opinion of the investigator patients currently on statin therapy other thanatorvastatin (10mg, 20mg or 40mg) or rosuvastatin (5mg, 10mg or 20 mg) can be switchedto rosuvastatin (5mg, 10mg or 20mg) at Visit 1.
Exclusion
Exclusion Criteria:
Clinically significant heart disease which will require coronary bypass, PCI, cardiactransplantation, surgical repair and/or replacement during the course of the study.
Coronary artery bypass graft (CABG) procedure within the past 90 days.
Previous or current diagnosis of severe heart failure (NYHA Class III-IV) or adocumented left ventricular ejection fraction (LVEF) of <25% as determined by contrastleft ventriculography, radionuclide ventriculography or echocardiography the absenceof an LVEF measurement in a patient without a previous or current diagnosis of heartfailure does not prohibit entry into the study.
Patients with evidence of cardiac electrophysiologic instability including a historyof uncontrolled ventricular arrhythmias, uncontrolled atrial fibrillation/flutter oruncontrolled supraventricular tachycardias with a ventricular response heart rate of >100 beats per minute at rest within 4 weeks prior to Visit 1.
Evidence of renal impairment as determined by any one of the following:
serum creatinine >1.5 mg/dL (>133 micromol/L) at screening Visit 1
a history of dialysis
a history of nephritic syndrome
Have hypertension that is uncontrolled defined as 2 consecutive measurements ofsitting blood pressure of systolic >160 mm Hg or diastolic >95 mm Hg at Visit 1.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of afemale after conception and until the termination of gestation, confirmed by apositive beta-hCG laboratory test (≥5 mIU/mL).
Current or recent (within 12 month prior to Visit 1) treatment with immunosuppressants (eg, Cyclosporine).
Triglycerides >400 mg/dL at screening Visit 1.
Atorvastatin >40 mg daily
Rosuvastatin >20 mg daily
Use of fibrates any dose or niacin/nicotinic acid 250 mg or more within 90 days priorto Visit 1.
Any medical or surgical condition which might significantly alter the absorption,distribution, metabolism or excretion of medication including, but not limited to anyof the following: cholecystitis, Crohn's disease, ulcerative colitis, or any gastricbypass alteration.
Evidence of hepatic disease as determined by any one of the following:
ALT, AST or GGT values >ULN by central lab at screening, Visit 1
a history of hepatic encephalopathy,
history of Hepatitis B, C or E,
a history of esophageal varices, or
a history of portocaval shunt.
A total bilirubin that is >ULN by central lab at screening, Visit 1.
History of malignancy of any organ system, treated or untreated, within the past 5years whether or not there is evidence of local recurrence or metastases, with theexception of localized basal cell carcinoma of the skin.
History or evidence of drug or alcohol abuse within the last 12 months.
Any surgical or medical condition, which in the opinion of the investigator, may placethe patient at higher risk from his/her participation in the study, or is likely toprevent the patient from complying with the requirements of the study or completingthe study.
Use of other investigational drugs and devices at the time of enrollment, or within 30days or 5 half-lives of enrollment, whichever is longer.
History of noncompliance to medical regimens or unwillingness to comply with the studyprotocol.
Any condition that in the opinion of the investigator would confound the evaluationand interpretation of efficacy and/or safety data.
Persons directly involved in the execution of this protocol
Study Design
Study Description
Connect with a study center
East Burger Street, Bloemfontein 9301
South AfricaSite Not Available
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Fichardt Park, Bloemfontein 9301
South AfricaSite Not Available
Westdene, Bloemfontein 9301
South AfricaSite Not Available
Goodwood, Cape Town 7460
South AfricaSite Not Available
Kraaifontein, Cape Town 7570
South AfricaSite Not Available
UCT Health Sciences Faculty
Observatory, Cape Town 7925
South AfricaSite Not Available
Pinelands, Cape Town 7405
South AfricaSite Not Available
Chatsworth, Durban 4092`
South AfricaSite Not Available
Congella, Durban 4001
South AfricaSite Not Available
Merebank, Durban 4052
South AfricaSite Not Available
Sydenham, Durban 4091
South AfricaSite Not Available
Tongaat, Durban 4400
South AfricaSite Not Available
Umhlanga, Durban 4321
South AfricaSite Not Available
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Boksburg North, Johannesburg 1460
South AfricaSite Not Available
Lenasia, Johannesburg 1827
South AfricaSite Not Available
Halfway House, Midrand 1685
South AfricaSite Not Available
Die Wilgers, Pretoria 0041
South AfricaSite Not Available
Eloffsdal, Pretoria 0084
South AfricaSite Not Available
Kuils River, Western Cape 7580
South AfricaSite Not Available
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Paarl, Western Cape 7646
South AfricaSite Not Available
Parow, Western Cape 7500
South AfricaSite Not Available
Somerset West, Western Cape 7130
South AfricaSite Not Available
Stellenbosch, Western Cape 7600
South AfricaSite Not Available
Worcester, Western Cape 6850
South AfricaSite Not Available
Bloemfontein, 9301
South AfricaSite Not Available
Cape Town, 7925
South AfricaSite Not Available
Johannesburg, 1460
South AfricaSite Not Available
Western Cape, 7646
South AfricaSite Not Available

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