AM398- Healthy diagnosed with High Cholesterol
San Antonio - Texas
ICON Development Solutions is conducting a research study of an investigational medication in male/female volunteers, with hyperlipidemia and on a stable dose of statin, ages 18-70.
The investigational drug under study is being developed for the treatment of high cholesterol and will be given as an injection under the skin in the abdomen.
The purpose of the study is to test the safety, tolerability and immune response of multiple doses of the investigational medication in subjects on a stable dose of Crestor ®(Rosuvastatin), Lipitor® (Atorvastatin) or Zocor® (Simvastatin) .
Participants will complete:
· 1 screening visit
· 16 outpatient visits (Non-consecutive) over a 13 week period
You may be compensated up to $105 per study visit for time and travel.
If you are able to answer “YES” to the following statements, you may qualify for this study.
I am between 18-70 years old.
My BMI is between 1 8 and 35kg/m2 .
I am currently taking Crestor ®(Rosuvastatin) (>5mg/day), Lipitor ®(Atorvastatin) (>20mg/day) or Zocor® (Simvastatin) (>40mg/day) and my dose has not changed in the last 3 months.
I have not taken any other lipid lowering medication other Crestor® (Rosuvastatin), Lipitor® (Atorvastatin) or Zocor® (Simvastatin) in the last 3 months.
I am not a type I or type II diabetic.
Female subjects may not currently be breastfeeding and must meet one of the following criteria to continue:
I am surgically sterile (hysterectomy ,bilateral oophorectomy, or bilateral tubal ligation).
I am postmenopausal (no period for at least 1 year).
Male Subject must meet the following criteria to continue:
I do not currently have a pregnant partner.
I am willing to inform my partner of my participation in this study.
I am willing to practice one of the following methods of birth control for the duration of the study until 70 days after the last dose of investigational drug: abstinence, vasectomy, condom with spermicide with either barrier methods, hormonal birth control or IUD used by the female partner.
I do not smoke or I do not smoke more than 10 cigarettes per day, more than 1 cigar or 1 pipe per day.
I do not have a history of any of the following:
- fibromyalgia, myositis or rhabdomyolysis or unexplained muscle pain
- Cardiovascular disease to include peripheral artery or cerebrovascular disease
- Homozygous familial hypercholesterolemia
- cancer (other than cervical cancer or non-melanomatous skin surgically excised more than 5 years ago).
- drug or alcohol abuse within the past year.
I have not donated or lost 500mL of blood or products within the past 2 months.
I have not participated in a clinical trial within the last 30 days where I received an investigational drug.
I am not being treated for high blood pressure or I am being treated and have been on a stable dose of blood pressure medication for at least 3 months and expect to remain on this medication and dose for the duration of the study.
I have not taken any of the following in the last 30 days:
- Oral contraceptive therapy (hormone replacement therapy and estrogen vaginal creams are ok)
- Anabolic steroids, including testosterone injections (stable daily dose testosterone replacement is ok)
I have not taken any of the following in the last 3 months:
- Fish oil, niacin
- Ezetimibe
- Fibrates
It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures. Frequently, individuals do not qualify because of medical history, or minor changes in vital signs, ECG and lab tests. Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, individuals are screened on a first come first served basis, and studies may complete enrollment prior to your visit. Additionally, no guarantees can be made regarding group assignments for any particular study. ICON will not assume any liability for lost time, travel or failure to qualify.
To fully qualify, it will be necessary to obtain blood samples after a 10 hour fast . You have the option of coming to the screening appointment fasting or you may return at a later date to obtain fasting blood work. If you choose to come fasting, you will need to refrain from eating or drinking anything (with the exception of water) 10 hours before your appointment.
We will be testing for alcohol and illegal drugs. You have the option of obtaining a urine sample at the screening appointment or you may return at a later date to obtain urine for an alcohol and drug sample. If you choose to have the sample obtained at screening, you will need to refrain from consuming alcohol 24 hours before your appointment.
If you are able to answer “YES” to the above questions and would like to make an appointment online please click on the following link:
Appointments cannot be made online for this study. Please call 210-CALL IDS (225-5437) or toll free 1-877-848-7425 to schedule an appointment.
Study Dates: This is an all Outpatient study (no overnight stays).
NEW GROUPS ARE FORMED AS PATIENTS QUALIFY. GENERALLY, YOU WILL START WITHIN TWO WEEKS FROM WHEN YOU SCREEN.
Group 1 - EXAMPLE DATES
Visit 1: 05Sep10 Sun
Visit 2: 09Sep10 Thurs
Visit 3: 12Sep10 Sun
Visit 4: 16Sep10 Thurs
Visit 5: 23Sep10 Thurs
Visit 6: 30Sep10 Thurs
Visit 7: 07Oct10 Thurs
Visit 8: 14Oct10 Thurs
Visit 9: 18Oct10 Mon
Visit 10: 21Oct10 Thurs
Visit 11: 28Oct10 Thurs
Visit 12: 04Nov10 Thurs
Visit 13: 11Nov10 Thurs
Visit 14: 18Nov10 Thurs
Visit 15: 25Nov10 Thurs
Visit 16: 02Dec10 Thurs
Notice:
In order to schedule a screening appointment online, you will be required to enter your personal information (name, DOB, etc.) into a secure, password protected database. Your information will remain confidential and will not be accessible by any party that does not work directly for ICON Clinical Research. It may be necessary for the recruitment staff to contact you by phone in the event of a schedule change or if more information is needed. You have the right to remove your information from the database at anytime by logging in to the scheduling program and choosing “My Profile” and then selecting the “Terminate Account” button.