Status:
COMPLETED
A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia
Lead Sponsor:
Shionogi
Collaborating Sponsors:
Integrium
Conditions:
Combined Hyperlipidemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a multi-center, double blind, prospective, longitudinal, randomized, 12-week study with a 52-week open-label follow-up to evaluate the safety and efficacy of daily administration of Pravastati...
Eligibility Criteria
Inclusion
- Patients meeting all the criteria listed below may be selected to enroll into the Selection Phase of the study:
- Male or female patients from 18-75 years of age, inclusive at the time of dosing with a history of a combined hyperlipidemia.
- 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.
- 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).
- Able to comply with all study procedures.
- 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:
- 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.
- Patients still meeting the selection criteria a, c, d and e as listed under section 4.1.
- Patients with a compliance ≥ 80% during the 8-week Pravastatin phase of the study.
Exclusion
- Patients will be excluded from the study if any one or more of the following apply:
- Female of childbearing potential who is pregnant and/or lactating and/or sexually active but not using an acceptable method of contraception
- History of allergy or contraindications to:
- fenofibrate or similar compounds
- HMG-CoA reductase inhibitors
- History of uncontrolled or unstable;
- diabetes ((i.e., diabetic nephropathy etc.),
- hepatic impairment/insufficiency,
- renal impairment/insufficiency (i.e., nephritis, polycystic kidney disease, acute or chronic renal failure, end-stage renal disease, GFR \< 60 ml/min, etc.),
- neurological,
- gastrointestinal (ulcerative colitis, Barrett's, etc.),
- 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
- Acute liver disease or persistent elevations in liver function tests (2 times the upper normal limit or greater)
- Levels of creatine phosphokinase (CK) 3 times the upper normal limit or greater
- Change in diuretic or β-blocker treatment for hypertension within 30 days of enrollment into the selection phase (Visit 1)
- 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)
- 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
- 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
- Hyperlipidemia type I-IIa-IV-V
- LDL \< 100 mg/dL
- TG \< 150 mg/dL or \> 400 mg/dL
- Uncontrolled primary hypothyroidism
- History of an acute myocardial infarction, stroke within the last 6 month prior to Visit 1; unstable angina or clinically significant heart failure
- Uncontrolled hypertension, as defined by SBP \>160 mmHg or DBP \>100 mmHg while on anti-hypertensive medication
- 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)
- Use of any of the prohibited medications as detailed in the concomitant medication section
- Non adherence to the American Heart Association Step II diet introduced at Visit 1
- 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
- \-
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
481 Patients enrolled
Trial Details
Trial ID
NCT00459745
Start Date
April 1 2007
End Date
July 1 2009
Last Update
April 24 2018
Active Locations (57)
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1
Anasazi Internal Medicine
Phoenix, Arizona, United States, 85032
2
Cochise Clinical Research
Sierra Vista, Arizona, United States, 85635
3
Memorial Research Medical Clinic
Long Beach, California, United States, 90806
4
Clinical Trials Research
Roseville, California, United States, 95661