DeLand, FL (PRWEB) February 11, 2014
*To see if you qualify for this High Cholesterol Clinical Study in DeLand, visit Avail Clinical Research on the web (http://www.availclinical.com) or contact us directly at (386) 785-2404. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.
This study is a Phase 3, multi-center clinical trial designed to compare the efficacy, safety and tolerability of a new drug for high cholesterol to a placebo for LDL-C lowering in subjects with primary hyperlipidemia or mixed dyslipidemia at high or very high risk for CV events. The study will enroll approximately 800 subjects in each of the 2 treatment arms, for a total of approximately 1600 subjects randomized at approximately 100 sites, who will receive the study drug for 18 months.
DURATION OF STUDY PARTICIPATION
After providing consent, subjects will enter a screening period of approximately 28 days to verify their eligibility for the trial. Eligible subjects will be considered enrolled and progress to the Randomization visit. Results from screening evaluations will be reviewed and only subjects who continue to meet all eligibility criteria will be randomized. Randomized subjects will enter the 12-week treatment period, followed by a 68-week long-term treatment period and an 8 week follow-up, for a total of 88 weeks (approximately 20 months) study participation.
BACKGROUND & RATIONALE
Lipids, such as cholesterol and triglycerides, are water insoluble molecules carried and stored in lipoprotein particles in blood. The majority of blood cholesterol is carried on low density lipoprotein (LDL), which is one of the five major groups of lipoproteins, including chylomicrons, very low density lipoprotein (VLDL), intermediate density lipoprotein (IDL), low density lipoprotein (LDL), and high density lipoprotein (HDL).
Cardiovascular disease (CVD) due to atherosclerosis continues to be the leading single cause of death in industrialized countries. High serum lipid levels, and especially high low density lipoprotein cholesterol (LDL-C) levels, have been demonstrated to strongly and directly correlate with CVD risks by numerous epidemiological studies. Moreover, large prospective clinical outcome trials have demonstrated that lowering LDL-C decreases cardiovascular morbidity and mortality. Despite the availability of lipid lowering therapies such as statins and ezetimibe, a significant percentage of subjects at high risk for CVD fail to reach or maintain their LDL-C treatment target (2.59 mmol/L for subjects without pre-existing CVD and 1.8 mmol/L for subjects with pre-existing CVD), due to insufficient efficacy, safety concerns with high doses of current lipid lowering drugs and poor subject compliance.
The benefit of participation for all subjects in this study, is close monitoring of their medical condition and safety. Those randomized to the active treatment arm may have a benefit of a lower risk of cardiovascular (CV) events. Those randomized to the placebo arm are not expected to obtain any additional benefit, beyond close monitoring of their medical condition and safety. A potential risk of participation, for all subjects, is the occurrence of injection site reactions. For those receiving active treatment, there may be an additional risk of achieving a very low LDL-C. It is not known if there are any risks associated with very low LDL cholesterol levels.
To demonstrate a superior LDL-C lowering effect of this experimental cholesterol drug when administered by the SC route Q2wks compared to a placebo, in subjects with primary hyperlipidemia or mixed dyslipidemia at high and very high risk for CV events receiving a maximally tolerated dose of statin therapy.
Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Males and females 18 years of age.
- Diagnosed with primary hyperlipidemia or mixed dyslipidemia.
- Subjects are required to be treated with atorvastatin, simvastatin, or rosuvastatin at the highest locally approved dose. If at a lower dose, there must be documentation that the subject is receiving a maximally tolerated dose of the aforementioned statins; and no dose should be lower than atorvastatin 20 mg, rosuvastatin 20 mg, or simvastatin 40 mg.
- Subjects on simvastatin 80 mg must have been on this dose for more than 1 year before screening.
- All subjects must be on a stable dose at least 6 weeks prior to screening. There should be no plans at the time of screening and randomization to modify the dose of statin for the duration of the trial.
- Source records and case report form (CRF) must show documentation of the requirements shown above.
- Subjects should be at high or very high risk of incurring a CV event, defined as:
Known CVD or CVD risk equivalents:
- Known history of CVD.
- Coronary heart disease: history of acute myocardial infarction, evidence of silent myocardial infarction or myocardial ischemia, history of unstable angina and stable angina pectoris, and history of coronary procedures (coronary angioplasty and coronary artery surgery), or;
- Other clinical atherosclerotic diseases: peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease (symptomatic [eg, transient ischemic attack or stroke of carotid origin] or >50 percent stenosis on angiography or ultrasound), and likely other forms of clinical atherosclerotic disease (eg, renal artery disease), or;
- Type 2 or Type 1 diabetes, or;
- Chronic kidney disease (CKD), defined as glomerular filtration rate (GFR) calculated by Modification of Diet in Renal Disease (MDRD) formula between 30 and 60 mL/min/1.73m2 (inclusive).
- Presence of multiple risk factors:
- Subjects who do not have past CVD disease or CVD risk equivalents but have 3 or more of the risk factors from the list below:
- Current cigarette smoking defined as any smoking for 30 days or more at the time of screening.
- HDL-C less than 40 mg/dL at screening.
- Family history of premature CHD (CHD in male first-degree relative less than 55 years; CHD in female first-degree relative less than 65 years).
- Age (men 55 years; women 65 years).
- hs-CRP greater than 2.0 mg/L at screening.
- Lipids should meet the following criteria on a background treatment with a statin at the 2 screening visits:
- Subjects with known CVD or CVD risk equivalents at the highest approved dose of statins described above:
- Fasting LDL C greater than or equal to 70 mg/dL (1.81 mmol/L) at both screening visits and the value at the second screening visit within 7 days of randomization 3 must not be lower or higher than 20% of this initial value, as described in Section 7.1.
- Subjects not at the highest approved dose of statins described above:
- Fasting LDL C greater than or equal to 77 mg/dL (1.99 mmol/L) at both screening visits and the value at the second screening visit within 7 days of randomization 3 must not be lower or higher than 20% of this initial value, as described in Section 7.1.
- Subjects with multiple risk factors (Refer to 6b, above) at the highest approved dose of statins described above:
- Fasting LDL C greater than or equal to 100 mg/dL (2.59 mmol/L) at both screening visits and the value at the second screening visit within 7 days of randomization 3 must not be lower or higher than 20% of this initial value, as described in Section 7.1.
- Subjects not at the highest approved dose of statins described in 5, above:
- Fasting LDL C greater than or equal to 110 mg/dL (2.85 mmol/L) at both screening visits and the value at the second screening visit within 7 days of randomization 3 must not be lower or higher than 20% of this initial value, as described in Section 7.1.
- Fasting TG less than or equal to 400 mg/dL (4.51 mmol/L) at the second screening visit within 7 days of randomization.
- Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 63 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
- Female subjects who are not of childbearing potential (ie, meet at least one of the following criteria):
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure or;
- Achieved post-menopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicule-stimulating hormone(FSH) level within the laboratory’s reference range for postmenopausal females.
- Avail Clinical Research conducts a variety of Clinical Research Studies in Florida. For more information about participating in a High Cholesterol Clinical Trial, please visit our website or contact us directly at (386) 785-2404.