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Therapeutic Areas: Cardiology/Vascular Diseases
Disease Category: Atherosclerosis

Trial Information

This research study is being done to assess the safety and tolerability of an investigational drug over a 12 week period in subjects with established atherosclerosis who are on a stable statin dose.

Your participation in this study will last for approximately 12weeks. You will first be evaluated to determine if you meet the criteria for the study. This is done by asking you questions about your medical history and medications you are currently taking, by testing your blood, PET SCAN , MRI and physical examination. If you meet the criteria, you will be randomized (like a flip of a coin) to receive either the investigational drug or placebo (inactive substance.) Neither you nor your study doctor will know which dose you are receiving or your cholesterol results during this phase of the study. You will be asked to return to the clinic in two weeks for Visit 4 and the next five visits (Visits 5-9) will be scheduled for every two weeks. At each visit vital signs, blood and urine will be obtained. You will be required to monitor your blood pressure for 24 hours and have another eye exam and PET scan between Visit 8 and Visit 9 and an ECG will be obtained at Visits 5, 7, and 9. At Visits 5-8 you will be required to remain in our clinic for additional time so that blood samples can be taken at different times throughout the day to evaluate the level of drug in your blood. You will not be charged for any of the study visits or medications. You will be given a stipend for all visits completed. If you would like to be considered for participation in this study, please contact us at the number listed below.

Patient Inclusion Criteria:

• Male or female, aged 50 to 80 years inclusive, at screening
• Body weights > 50 kg and BMI within the range 19- 35kg/m2 (inclusive).
• Documented atherosclerotic vascular disease and clinically stable for at least 6months.
• If diabetic, have well controlled diabetes defined for he purpose of the study as:
  • HbA1c =8% or FPG =200 mg/dL Evidence of plaque inflammation [carotid artery or ascending aorta plaque inflammation defined as TBR = 1.6]
  • On a stable dose of a Statin for 3 months prior to screening with no evidence of Statin intolerance.

Patient Exclusion Criteria:

• Recent (i.e., <6 months from Screening Visit) CV event.
• Current inadequately controlled hypertension (blood pressure =160 mmHg systolic or =100 mmHg diastolic) on a stable dose of anti-hypertensive medication.
• Serum triglycerides >400 mg/dL
• LDLc >130 mg/dL
• QTc interval =450msec at screening or =480 msec for subjects with bundle branch block.
• Renal impairment with serum creatinine > 2.0mg/dl or history of kidney transplant or status post nephrectomy.

History of myopathy or inflammatory muscle disease.

Chioma Okoro, Clinical research coordinator
The Rogosin Institute
1167 York Ave
New York, NY 10065
Phone: 212-702-9600
Fax: 212-702-9588
EMail: cno9001@nyp.org

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