A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia
A Multi-Center, Prospective, Longitudinal, Randomized, Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of Daily Administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the Combination of Pravastatin and Fenofibrate 40/160 mg) for 12 Weeks Followed by a 52-Week Open-Label Safety Phase of the Pravafen Alone in the Treatment of Combined Hyperlipidemia.
1 other identifier
interventional
481
1 country
57
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 Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of both Pravastatin and Fenofibrate 40/160 mg) in the treatment of combined hyperlipidemia. There will be an open-label, 8-week, Selection Phase prior to randomization in which all patients will be stabilized on Pravastatin 40 mg/day. Following the Selection Phase, and if the patients meet all inclusion/exclusion criteria, they will be randomized to a three arm, double blind, 12-week Efficacy Phase during which they would receive either Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg). The 12-week Efficacy Phase will be followed by an open-label, 52-week, Safety Phase in which all patients will receive Pravafen. After the 8-week Selection Phase, patients that still meet the inclusion/exclusion criteria will be randomized on a 1:1:2 ratio to Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of both Pravastatin and Fenofibrate 40/160 mg) for 12 weeks. After the completion of the 12-week double-blind phase of the study, all patients that haven't had changes in their well being, will be allowed to roll-over into the 52-week, open-label, follow-up portion of the study. During the 52 week, open label, Safety Phase of the study, all patients will receive Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg). Patients will be evaluated at baseline and every three weeks thereafter throughout the initial 12-week Efficacy Phase of the study. Patients that roll-over into the 52-week, open-label, follow-up Safety Phase will be evaluated at 12, 24, 36 and 52 weeks. Participation in the study can be up to 72 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2007
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 9, 2007
CompletedFirst Posted
Study publicly available on registry
April 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedApril 24, 2018
August 1, 2010
1 year
April 9, 2007
April 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary endpoints will assess differences in change from baseline in non-HDL-C, for the patients receiving Pravafen versus the patients receiving Pravastatin or Fenofibrate at the end of the 12-week portion of the study.
Change in HDL
bBaseline to 12 weeks
Secondary Outcomes (2)
Secondary endpoints will assess differences in change from baseline in TC, TG, LDL-C, HDL-C and TC/HDL-C for the pts receiving the combo therapy vs the pts receiving Pravastatin or Fenofibrate
Baseline to 12 weeks
Differences in change from baseline in ALT, AST and CK as well as overall safety for the pts receiving the combo therapy vs the pts receiving Pravastatin or Fenofibrate at the end of the 12-week of the study
Baseline to 12 weeks
Study Arms (3)
Pravastatin
ACTIVE COMPARATORPravastatin 40 mg
Fenofibrate
ACTIVE COMPARATORFenofibrate 160 mg
Pravafen (Parvastatin and Fenofibrate)
EXPERIMENTALCombined Therapy of Pravastatin 40 mg and Fenofibrate 160 mg.
Interventions
Eligibility Criteria
You may qualify if:
- 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 NaĂ¯ve 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 NaĂ¯ve 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.
You may not qualify if:
- 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
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
Anasazi Internal Medicine
Phoenix, Arizona, 85032, United States
Cochise Clinical Research
Sierra Vista, Arizona, 85635, United States
Memorial Research Medical Clinic
Long Beach, California, 90806, United States
Clinical Trials Research
Roseville, California, 95661, United States
Orange County Research Center
Tustin, California, 92780, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32205, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Drug Study Institute
Jupiter, Florida, 33458, United States
Mima Century Research Associates
Melbourne, Florida, 32901, United States
Cardiology Research Associates
Ormond Beach, Florida, 32174, United States
Atlanta Vascular Research Foundation
Atlanta, Georgia, 30084, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Welborn Clinic Research Center
Evansville, Indiana, 47713, United States
MediSphere Medical Research Center LLC
Evansville, Indiana, 47714, United States
Research Institute of Middle America
Jeffersonville, Indiana, 47130, United States
Welborn Clinic Gateway
Newburgh, Indiana, 47630, United States
Lemarc Research Center
Louisville, Kentucky, 40213, United States
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, 40291, United States
Androscoggin Cardiology Associates
Auburn, Maine, 04210, United States
MODEL Clinical Research
Baltimore, Maryland, 21204, United States
Health Trends Research, LLC
Baltimore, Maryland, 21208, United States
MD Medical Research
Oxon Hill, Maryland, 20745, United States
Clinical Research Center of Cape Cod, Inc
West Yarmouth, Massachusetts, 02673, United States
Clinical Study Site
Florissant, Missouri, 63031, United States
Mercy Medical Group
Manchester, Missouri, 63021, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Bronx Nephrology Hypertension, P.C.
The Bronx, New York, 10467, United States
Capital Cardiology Associates
Troy, New York, 12180, United States
Metrolina Medical Research
Charlotte, North Carolina, 28209, United States
Sensenbrenner Primary Care LLC
Charlotte, North Carolina, 28277, United States
Triangle Medical Research Associates
Raleigh, North Carolina, 27609, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Crescent Medical Research Associates
Salisbury, North Carolina, 28144, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103, United States
Sterling Research Group
Cincinnati, Ohio, 45219, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219, United States
Ohio Clinical Research
Hudson, Ohio, 44236, United States
Wells Institute for Health Awareness
Kettering, Ohio, 45429, United States
Ohio Clinical Research, LLC
Lyndhurst, Ohio, 44124, United States
Bluestem Cardiology
Bartlesville, Oklahoma, 74006, United States
Lynn Institute of Norman
Norman, Oklahoma, 73071, United States
Willamette Valley Clinical Studies
Eugene, Oregon, 97404, United States
Fleetwood Clinical Research
Fleetwood, Pennsylvania, 19522, United States
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, 09114, United States
Southern Berks Family Medicine
Reading, Pennsylvania, 19606, United States
Tipton Medical Center
Tipton, Pennsylvania, 16684, United States
Palmetto Medical Research Associates
Mt. Pleasant, South Carolina, 29464, United States
Upstate Pharmaceutical Research
Simpsonville, South Carolina, 29681, United States
TriCities Medical Research Associates
Bristol, Tennessee, 37620, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Clinical Trials Research
Austin, Texas, 78705, United States
Texas Medical Research LLC
San Antonio, Texas, 78238, United States
Hampton Roads Center for Clinical Research
Norfolk, Virginia, 23502, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
National Clinical Research
Richmond, Virginia, 23294, United States
Rainier Clinical Research Center Inc.
Renton, Washington, 98057, United States
Cedar Research LLC
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2007
First Posted
April 12, 2007
Study Start
April 1, 2007
Primary Completion
April 1, 2008
Study Completion
July 1, 2009
Last Updated
April 24, 2018
Record last verified: 2010-08