1. Latest News
  2. Submit Press Release
  1. PR Home
  2. Latest News
  3. Feeds
  4. Alerts
  5. Submit Free Press Release
  6. Journalist Account
  7. PRNewswire Distribution

Paid High Cholesterol Clinical Trial Now Enrolling at Avail Clinical Research Near Orlando, Florida

Avail is conducting a randomized, placebo-controlled study to assess the efficacy, long-term safety and tolerability of a new high cholesterol drug in subjects with primary hyperlipidemia or mixed dyslipidemia at risk of cardiovascular events.

FOR IMMEDIATE RELEASE

 
PRLog (Press Release) - Feb. 12, 2014 - DELAND, Fla. -- *To see if you qualify for this High Cholesterol Clinical Study in DeLand (http://www.availclinical.com/trial/high-cholesterol/), visit Avail Clinical Research on the web (http://www.availclinical.com (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.

STUDY DESIGN

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

Eligible subjects will be considered enrolled and progress to the Randomization visit (http://www.availclinical.com/clinical-study/clinical-tria...). 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

Cardiovascular disease (CVD) due to atherosclerosis continues to be the leading single cause of death in industrialized countries (http://www.availclinical.com/news/american-heart-month/). 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 (http://www.availclinical.com/news/control-cholesterol-pre...).

PRIMARY OBJECTIVES

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.

INCLUSION CRITERIA

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.

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: 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.

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.

Avail Clinical Research conducts a variety of Clinical Research Studies in Florida (http://www.availclinical.com/trial/). For more information about participating in a High Cholesterol Clinical Trial, please visit our website or contact us directly at (386) 785-2404.

Contact
Jennifer Economou
(386) 785-2400 336
***@availclinical.com

--- End ---

Click to Share

Contact Email:
***@availclinical.com Email Verified
Source:Avail Clinical Research
City/Town:Deland - Florida - United States
Industry:Medical, Research
Tags:high cholesterol, heart health, clinical trials, clinical studies, clinical research
Shortcut:prlog.org/12281917
Disclaimer:   Issuers of the press releases are solely responsible for the content of their press releases. PRLog can't be held liable for the content posted by others.   Report Abuse

Latest Press Releases By “

More...

Trending News...



  1. SiteMap
  2. Privacy Policy
  3. Terms of Service
  4. Copyright Notice
  5. About
  6. Advertise
Like PRLog?
9K2K1K
Click to Share