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A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia

Primary Purpose

Combined Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Pravafen
Pravastatin
Fenofibrate
Sponsored by
Shionogi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Combined Hyperlipidemia focused on measuring Cardiovascular Disease, Fenofibrate, LDL cholesterol, HDL cholesterol, Hyperlipidemia, Pravastatin, Triglycerides

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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
  2. History of allergy or contraindications to:

    • fenofibrate or similar compounds
    • HMG-CoA reductase inhibitors
  3. 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
  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

    -

Sites / Locations

  • Anasazi Internal Medicine
  • Cochise Clinical Research
  • Memorial Research Medical Clinic
  • Clinical Trials Research
  • Orange County Research Center
  • Jacksonville Center for Clinical Research
  • Jacksonville Center for Clinical Research
  • Drug Study Institute
  • Mima Century Research Associates
  • Cardiology Research Associates
  • Atlanta Vascular Research Foundation
  • East-West Medical Research Institute
  • Welborn Clinic Research Center
  • MediSphere Medical Research Center LLC
  • Research Institute of Middle America
  • Welborn Clinic Gateway
  • Lemarc Research Center
  • Bluegrass Clinical Research, Inc.
  • Androscoggin Cardiology Associates
  • MODEL Clinical Research
  • Health Trends Research, LLC
  • MD Medical Research
  • Clinical Research Center of Cape Cod, Inc
  • Clinical Study Site
  • Mercy Medical Group
  • Comprehensive Clinical Research
  • Bronx Nephrology Hypertension, P.C.
  • Capital Cardiology Associates
  • Metrolina Medical Research
  • Sensenbrenner Primary Care LLC
  • Triangle Medical Research Associates
  • Wake Research Associates
  • Crescent Medical Research Associates
  • Piedmont Medical Research Associates
  • Sterling Research Group
  • The Lindner Clinical Trial Center
  • Ohio Clinical Research
  • Wells Institute for Health Awareness
  • Ohio Clinical Research, LLC
  • Bluestem Cardiology
  • Lynn Institute of Norman
  • Willamette Valley Clinical Studies
  • Fleetwood Clinical Research
  • Philadelphia Clinical Research, LLC
  • Southern Berks Family Medicine
  • Tipton Medical Center
  • Palmetto Medical Research Associates
  • Upstate Pharmaceutical Research
  • TriCities Medical Research Associates
  • Holston Medical Group
  • Clinical Trials Research
  • Texas Medical Research LLC
  • Hampton Roads Center for Clinical Research
  • Clinical Research Associates of Tidewater
  • National Clinical Research
  • Rainier Clinical Research Center Inc.
  • Cedar Research LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Pravastatin

Fenofibrate

Pravafen (Parvastatin and Fenofibrate)

Arm Description

Pravastatin 40 mg

Fenofibrate 160 mg

Combined Therapy of Pravastatin 40 mg and Fenofibrate 160 mg.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Changes in TC, TG, LDL-C, HDL-C and TC/HDL-C
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
Changes in ALT, AST and CK and overall safety

Full Information

First Posted
April 9, 2007
Last Updated
April 20, 2018
Sponsor
Shionogi
Collaborators
Integrium
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1. Study Identification

Unique Protocol Identification Number
NCT00459745
Brief Title
A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shionogi
Collaborators
Integrium

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Combined Hyperlipidemia
Keywords
Cardiovascular Disease, Fenofibrate, LDL cholesterol, HDL cholesterol, Hyperlipidemia, Pravastatin, Triglycerides

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
481 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pravastatin
Arm Type
Active Comparator
Arm Description
Pravastatin 40 mg
Arm Title
Fenofibrate
Arm Type
Active Comparator
Arm Description
Fenofibrate 160 mg
Arm Title
Pravafen (Parvastatin and Fenofibrate)
Arm Type
Experimental
Arm Description
Combined Therapy of Pravastatin 40 mg and Fenofibrate 160 mg.
Intervention Type
Drug
Intervention Name(s)
Pravafen
Other Intervention Name(s)
Combination of Pravastatin 40 mg and Fenofibrate 160 mg
Intervention Type
Drug
Intervention Name(s)
Pravastatin
Other Intervention Name(s)
Pravachol
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Primary Outcome Measure Information:
Title
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.
Description
Change in HDL
Time Frame
bBaseline to 12 weeks
Secondary Outcome Measure Information:
Title
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
Description
Changes in TC, TG, LDL-C, HDL-C and TC/HDL-C
Time Frame
Baseline to 12 weeks
Title
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
Description
Changes in ALT, AST and CK and overall safety
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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 -
Facility Information:
Facility Name
Anasazi Internal Medicine
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Cochise Clinical Research
City
Sierra Vista
State/Province
Arizona
ZIP/Postal Code
85635
Country
United States
Facility Name
Memorial Research Medical Clinic
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Clinical Trials Research
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Drug Study Institute
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Mima Century Research Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Cardiology Research Associates
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Atlanta Vascular Research Foundation
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Welborn Clinic Research Center
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
MediSphere Medical Research Center LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Research Institute of Middle America
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Welborn Clinic Gateway
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Lemarc Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Bluegrass Clinical Research, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
Androscoggin Cardiology Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
MODEL Clinical Research
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Health Trends Research, LLC
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
MD Medical Research
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
Clinical Research Center of Cape Cod, Inc
City
West Yarmouth
State/Province
Massachusetts
ZIP/Postal Code
02673
Country
United States
Facility Name
Clinical Study Site
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
Mercy Medical Group
City
Manchester
State/Province
Missouri
ZIP/Postal Code
63021
Country
United States
Facility Name
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Bronx Nephrology Hypertension, P.C.
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Capital Cardiology Associates
City
Troy
State/Province
New York
ZIP/Postal Code
12180
Country
United States
Facility Name
Metrolina Medical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Sensenbrenner Primary Care LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Triangle Medical Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Crescent Medical Research Associates
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Piedmont Medical Research Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Sterling Research Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio Clinical Research
City
Hudson
State/Province
Ohio
ZIP/Postal Code
44236
Country
United States
Facility Name
Wells Institute for Health Awareness
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Ohio Clinical Research, LLC
City
Lyndhurst
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Bluestem Cardiology
City
Bartlesville
State/Province
Oklahoma
ZIP/Postal Code
74006
Country
United States
Facility Name
Lynn Institute of Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Willamette Valley Clinical Studies
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Fleetwood Clinical Research
City
Fleetwood
State/Province
Pennsylvania
ZIP/Postal Code
19522
Country
United States
Facility Name
Philadelphia Clinical Research, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
09114
Country
United States
Facility Name
Southern Berks Family Medicine
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19606
Country
United States
Facility Name
Tipton Medical Center
City
Tipton
State/Province
Pennsylvania
ZIP/Postal Code
16684
Country
United States
Facility Name
Palmetto Medical Research Associates
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Upstate Pharmaceutical Research
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
TriCities Medical Research Associates
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Clinical Trials Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Medical Research LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78238
Country
United States
Facility Name
Hampton Roads Center for Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Clinical Research Associates of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
National Clinical Research
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Rainier Clinical Research Center Inc.
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Cedar Research LLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia

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