Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shionogi
With
Integrium
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients meeting all the criteria listed below may be selected to enroll into the Selection Phase of the study:
1. Male or female patients from 18-75 years of age, inclusive at the time of dosing with a history of a combined hyperlipidemia.
2. High LDL cholesterol and TG levels as per the table hereunder:
Prior treatment LDL Cholesterol TG Naïve to treatment\* \> 130 mg/dL and ≥ 150 mg/dL and ≤ 400 mg/dL Lipid Lowering Monotherapy \> 130 mg/dL and ≥ 150 mg/dL and ≤ 400 mg/dL Lipid Lowering Combination Therapy \> 110 mg/dL and ≥ 150 mg/dL and ≤ 400 mg/dL
\* A patient that has received NO lipid lowering therapy within 6 weeks prior to the Selection Visit, will be considered Naïve to treatment.
3. If the patient is female and of childbearing potential and sexually active, an acceptable birth control method must be used (abstinence, IUD, oral, transdermal, injectable or implantable contraceptives, at least 2 years post-menopausal, one year post hysterectomy, double barrier device and/or partner at least one year post vasectomy), a negative serum pregnancy test must be obtained at the Selection Visit (Visit 1) and a negative urine pregnancy test must be obtained prior to study drug administration at Baseline Visit (Visit 3).
4. Able to comply with all study procedures.
5. Patients that provide a written informed consent to participate in the study indicated by a personal signature and date on the patient consent form.
At the end of the Selection Phase, patients meeting all of the criteria listed below may be selected and randomized into the Efficacy Phase of the study:
1. Selected patients with LDL Cholesterol ≥ 100 mg/dl and/or TG ≥ 150 mg/dl and ≤ 400 mg/dl at Week-1 / Visit 2 after taking Pravastatin 40 mg/day from Visit 1.
2. Patients still meeting the selection criteria a, c, d and e as listed under section 4.1.
3. Patients with a compliance ≥ 80% during the 8-week Pravastatin phase of the study.
You may not be if
Patients will be excluded from the study if any one or more of the following apply:
1. Female of childbearing potential who is pregnant and/or lactating and/or sexually active but not using an acceptable method of contraception
* gallbladder disease (patients with prior cholecystectomy can be allowed to participate),
* psychiatric disease,
* sleep apnea
* any other clinically significant medical or surgical history that could affect the safety of the patient or hinder the evaluation of drug effect based on Investigator or Medical Monitor discretion
4. Acute liver disease or persistent elevations in liver function tests (2 times the upper normal limit or greater)
5. Levels of creatine phosphokinase (CK) 3 times the upper normal limit or greater
6. Change in diuretic or β-blocker treatment for hypertension within 30 days of enrollment into the selection phase (Visit 1)
7. Positive personal history of abuse of any of the following:
* Alcohol (as per the DSM-IV criteria) and/or
* Recreational drugs (as per the DSM-IV criteria)
8. Usage of any of the following medications (patients must have discontinued these medications for 5 or more half-lives or for 30 days, whichever is greater prior to study drug administration on Visit 3 / Day 0) :
* Corticosteroids
* Immunosuppressants
* Macrolide antibiotics
* Azole antifungal agents, or
9. Recent use of any investigational drug. These drugs must have been discontinued for either 5 or more half-lives or for 30 days whichever is greater prior to Visit 1
10. Hyperlipidemia type I-IIa-IV-V
11. LDL \< 100 mg/dL
12. TG \< 150 mg/dL or \> 400 mg/dL
13. Uncontrolled primary hypothyroidism
14. History of an acute myocardial infarction, stroke within the last 6 month prior to Visit 1; unstable angina or clinically significant heart failure
15. Uncontrolled hypertension, as defined by SBP \>160 mmHg or DBP \>100 mmHg while on anti-hypertensive medication
16. Type 1 diabetes or type 2 diabetes mellitus requiring insulin, and diabetic patients with poor control (HbA1c level \> 8.5%), abnormal renal function (GFR \< 60 ml/mn) or any renal disease likely to lead to renal dysfunctions)
17. Use of any of the prohibited medications as detailed in the concomitant medication section
18. Non adherence to the American Heart Association Step II diet introduced at Visit 1
19. Presence of any other condition or illness, which, in the opinion of the Principal Investigator, would interfere with the patient's participation in the study
