Combined HyperlipidemiaPhase 3NCT00459745
A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia
A Phase 3 study testing Pravafen, Pravastatin and Fenofibrate in people with Combined Hyperlipidemia, run by Shionogi at 57 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Combined Hyperlipidemia
- What is being tested?
- Pravafen, Pravastatin and Fenofibrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 481 participants
- Where
- 57 sitesUnited States
- Study dates
- Apr 2007to Jul 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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;
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- 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
- -
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
Atlanta Vascular Research Foundation
Atlanta, Georgia, 30084
Androscoggin Cardiology Associates
Auburn, Maine, 04210
Clinical Trials Research
Austin, Texas, 78705
MODEL Clinical Research
Baltimore, Maryland, 21204
Health Trends Research, LLC
Baltimore, Maryland, 21208
Bluestem Cardiology
Bartlesville, Oklahoma, 74006
Comprehensive Clinical Research
Berlin, New Jersey, 08009
TriCities Medical Research Associates
Bristol, Tennessee, 37620
Metrolina Medical Research
Charlotte, North Carolina, 28209
Sensenbrenner Primary Care LLC
Charlotte, North Carolina, 28277
Sterling Research Group
Cincinnati, Ohio, 45219
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
Willamette Valley Clinical Studies
Eugene, Oregon, 97404
Welborn Clinic Research Center
Evansville, Indiana, 47713
MediSphere Medical Research Center LLC
Evansville, Indiana, 47714
Fleetwood Clinical Research
Fleetwood, Pennsylvania, 19522
Clinical Study Site
Florissant, Missouri, 63031
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Ohio Clinical Research
Hudson, Ohio, 44236
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32205
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Research Institute of Middle America
Jeffersonville, Indiana, 47130
Drug Study Institute
Jupiter, Florida, 33458
Wells Institute for Health Awareness
Kettering, Ohio, 45429
Holston Medical Group
Kingsport, Tennessee, 37660
Memorial Research Medical Clinic
Long Beach, California, 90806
Lemarc Research Center
Louisville, Kentucky, 40213
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, 40291
Ohio Clinical Research, LLC
Lyndhurst, Ohio, 44124
Mercy Medical Group
Manchester, Missouri, 63021
Mima Century Research Associates
Melbourne, Florida, 32901
Palmetto Medical Research Associates
Mt. Pleasant, South Carolina, 29464
Welborn Clinic Gateway
Newburgh, Indiana, 47630
Hampton Roads Center for Clinical Research
Norfolk, Virginia, 23502
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507
Lynn Institute of Norman
Norman, Oklahoma, 73071
Cardiology Research Associates
Ormond Beach, Florida, 32174
MD Medical Research
Oxon Hill, Maryland, 20745
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, 09114
Anasazi Internal Medicine
Phoenix, Arizona, 85032
Triangle Medical Research Associates
Raleigh, North Carolina, 27609
Wake Research Associates
Raleigh, North Carolina, 27612
Southern Berks Family Medicine
Reading, Pennsylvania, 19606
Rainier Clinical Research Center Inc.
Renton, Washington, 98057
National Clinical Research
Richmond, Virginia, 23294
Clinical Trials Research
Roseville, California, 95661
Crescent Medical Research Associates
Salisbury, North Carolina, 28144
Texas Medical Research LLC
San Antonio, Texas, 78238
Cochise Clinical Research
Sierra Vista, Arizona, 85635
Upstate Pharmaceutical Research
Simpsonville, South Carolina, 29681
Cedar Research LLC
Tacoma, Washington, 98405
Bronx Nephrology Hypertension, P.C.
The Bronx, New York, 10467
Tipton Medical Center
Tipton, Pennsylvania, 16684
Capital Cardiology Associates
Troy, New York, 12180
Orange County Research Center
Tustin, California, 92780
Clinical Research Center of Cape Cod, Inc
West Yarmouth, Massachusetts, 02673
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103
About this study
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.
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).
Read more
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.
- Conditions
- Combined Hyperlipidemia
- Being tested
- Pravafen, Pravastatin, Fenofibrate
- Keywords
- Cardiovascular Disease, Fenofibrate, LDL cholesterol, HDL cholesterol, Hyperlipidemia, Pravastatin, Triglycerides
- Medical subject headings
- Cardiovascular Diseases, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PravafenDrug
Also called Combination of Pravastatin 40 mg and Fenofibrate 160 mg
PravastatinDrug
Also called Pravachol
FenofibrateDrug
| Study group | Role | What they receive |
|---|---|---|
| Pravastatin | Active comparator | Pravastatin 40 mg Receives: Drug: Pravastatin |
| Fenofibrate | Active comparator | Fenofibrate 160 mg Receives: Drug: Fenofibrate |
| Pravafen (Parvastatin and Fenofibrate) | Experimental | Combined Therapy of Pravastatin 40 mg and Fenofibrate 160 mg. Receives: Drug: Pravafen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Changes in TC, TG, LDL-C, HDL-C and TC/HDL-C
Measured: 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
Changes in ALT, AST and CK and overall safety
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combined HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 481 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459745
- Sponsor's protocol ID
- Sc-PRAVA-06-02
- Status last verified
- Aug 2010
- First submitted
- 9 Apr 2007
- Last updated
- 24 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00459745
- Acronym / sponsor ID
- Sc-PRAVA-06-02
- Conditions
- Combined Hyperlipidemia
- Keywords
- Cardiovascular Disease, Fenofibrate, LDL cholesterol, HDL cholesterol, Hyperlipidemia, Pravastatin, Triglycerides
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 481 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Collaborators
- Integrium
- Study start
- Apr 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 12 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pravastatin | Active comparator | Drug: PravastatinPravastatin 40 mg |
| Fenofibrate | Active comparator | Drug: FenofibrateFenofibrate 160 mg |
| Pravafen (Parvastatin and Fenofibrate) | Experimental | Drug: PravafenCombined Therapy of Pravastatin 40 mg and Fenofibrate 160 mg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- 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).
Key exclusion criteria (38 listed)
- 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:
- History of uncontrolled or unstable;
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PravafenAlso: Combination of Pravastatin 40 mg and Fenofibrate 160 mg | Drug | Pravafen (Parvastatin and Fenofibrate) |
| PravastatinAlso: Pravachol | Drug | Pravastatin |
| Fenofibrate | Drug | Fenofibrate |
Primary outcome
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.
Time frame: bBaseline to 12 weeks
Change in HDL
2 secondary outcomes
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
Time frame: 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
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
57 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pravafen, Pravastatin and Fenofibrate in people with Combined Hyperlipidemia, run by Shionogi at 57 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: bBaseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.