Primary DyslipidemiaPhase 4PREVAIL-USNCT01256476

Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia

A Phase 4 study testing pitavastatin and pravastatin in people with Primary Dyslipidemia and Mixed Dyslipidemia, run by Kowa Research Institute, Inc. at 44 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed dyslipidemia. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Primary Dyslipidemia, Mixed Dyslipidemia
What is being tested?: pitavastatin and pravastatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 328 participants
Where: 44 sitesUnited States
Study dates: Oct 2010to Jun 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female subjects with primary hypercholesterolemia or mixed dyslipidemia who are ≥18 and ≤80 years of age at the time of consent
Plasma Low-density lipoprotein cholesterol (LDL-C) ≥130 milligrams per deciliter (mg/dL) and ≤220 mg/dL and triglyceride (TG) levels of ≤400 mg/dL

Who cannot join

Homozygous familial hypercholesterolemia
Any conditions which may cause secondary dyslipidemia
Uncontrolled diabetes mellitus

Trial locations and contacts

44 sites in 1 country.

City, postcode or hospital

44 sites in 1 country

United States44 sites

Study site
Addison, Illinois
Study site
Baltimore, Maryland
Study site
Berlin, New Jersey
Study site
Beverly Hills, California
Study site
Brockton, Massachusetts
Study site
Chandler, Arizona
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Colorado Springs, Colorado
Study site
Corpus Christi, Texas
Study site
Dallas, Texas
Study site
DeLand, Florida
Study site
Edina, Minnesota
Study site
Erlanger, Kentucky
Study site
Eugene, Oregon
Study site
Evansville, Indiana
Study site
Fort Luaderdale, Florida
Study site
Goodyear, Arizona
Study site
Greer, South Carolina
Study site
Huntsville, Alabama
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Kansas City, Kansas
Study site
Las Vegas, Nevada
Study site
Los Angeles, California
Study site
Lyndhurst, Ohio
Study site
Miami, Florida
Study site
Mt. Pleasant, South Carolina
Study site
Muscle Shoals, Alabama
Study site
Newport Beach, California
Study site
Norfolk, Virginia
Study site
Olympia, Washington
Study site
Oviedo, Florida
Study site
Pembroke Pines, Florida
Study site
Phoenix, Arizona
Study site
Ponte Vedra, Florida
Study site
Richmond, Virginia
Study site
Rochester, New York
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Statesville, North Carolina
Study site
Tulsa, Oklahoma
Study site
Willoughby Hills, Ohio

Other trials in United States

About this study

Official title: A RANDOMIZED, DOUBLE-BLIND, ACTIVE CONTROLLED, PARALLEL GROUP STUDY OF PITAVASTATIN 4 MG VS. PRAVASTATIN 40 MG IN PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA

Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed dyslipidemia.

Conditions: Primary Dyslipidemia, Mixed Dyslipidemia
Being tested: pitavastatin, pravastatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pitavastatinDrug
Also called Livalo
pitavastatin 4 mg once daily (QD)
pravastatinDrug
Pravastatin 40 mg once daily (QD)

Study groups in NCT01256476
Study group	Role	What they receive
pitavastatin 4 mg once daily (QD)	Experimental	Not described Receives: Drug: pitavastatin
pravastatin 40 mg once daily (QD)	Active comparator	Not described Receives: Drug: pravastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12
Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Jun 2011

First posted8 Dec 2010 (estimated)
Study startOct 2010
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Primary DyslipidemiaStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 328 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01256476
Sponsor's protocol ID: NK-104-4.04US
Acronym: PREVAIL-US
Status last verified: May 2012
First submitted: 7 Dec 2010
Last updated: 8 May 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Miller PE, Martin SS, Joshi PH, Jones SR, Massaro JM, D'Agostino RB, Sponseller CA, Toth PP. Pitavastatin 4 mg Provides Significantly Greater Reduction in Remnant Lipoprotein Cholesterol Compared With Pravastatin 40 mg: Results from the Short-term Phase IV PREVAIL US Trial in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia. Clin Ther. 2016 Mar;38(3):603-9. doi: 10.1016/j.clinthera.2016.02.001. Epub 2016 Feb 26.
PubMed 26922296
Sponseller CA, Morgan RE, Kryzhanovski VA, Campbell SE, Davidson MH. Comparison of the lipid-lowering effects of pitavastatin 4 mg versus pravastatin 40 mg in adults with primary hyperlipidemia or mixed (combined) dyslipidemia: a Phase IV, prospective, US, multicenter, randomized, double-blind, superiority trial. Clin Ther. 2014 Aug 1;36(8):1211-22. doi: 10.1016/j.clinthera.2014.06.009. Epub 2014 Jul 3.
PubMed 24998014
Chapman MJ, Orsoni A, Robillard P, Hounslow N, Sponseller CA, Giral P. Effect of high-dose pitavastatin on glucose homeostasis in patients at elevated risk of new-onset diabetes: insights from the CAPITAIN and PREVAIL-US studies. Curr Med Res Opin. 2014 May;30(5):775-84. doi: 10.1185/03007995.2013.874989. Epub 2014 Jan 10.
PubMed 24328357

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
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Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

All Primary Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A RANDOMIZED, DOUBLE-BLIND, ACTIVE CONTROLLED, PARALLEL GROUP STUDY OF PITAVASTATIN 4 MG VS. PRAVASTATIN 40 MG IN PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA
ClinicalTrials.gov ID: NCT01256476
Acronym / sponsor ID: PREVAIL-US / NK-104-4.04US
Conditions: Primary Dyslipidemia, Mixed Dyslipidemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 328 participants (actual)
Lead sponsor: Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 8 Dec 2010 (estimated)
Results: Posted 30 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed dyslipidemia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
pitavastatin 4 mg once daily (QD)	Experimental	Drug: pitavastatin
pravastatin 40 mg once daily (QD)	Active comparator	Drug: pravastatin

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male and female subjects with primary hypercholesterolemia or mixed dyslipidemia who are ≥18 and ≤80 years of age at the time of consent
Plasma Low-density lipoprotein cholesterol (LDL-C) ≥130 milligrams per deciliter (mg/dL) and ≤220 mg/dL and triglyceride (TG) levels of ≤400 mg/dL

Key exclusion criteria (3 listed)

Homozygous familial hypercholesterolemia
Any conditions which may cause secondary dyslipidemia
Uncontrolled diabetes mellitus

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
pitavastatinAlso: Livalopitavastatin 4 mg once daily (QD)	Drug	pitavastatin 4 mg once daily (QD)
pravastatinPravastatin 40 mg once daily (QD)	Drug	pravastatin 40 mg once daily (QD)

Primary outcome

Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12
Time frame: Baseline and 12 weeks

Results and safety

Results posted to the registry on 30 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pitavastatin 4 mg Once a Day (QD)	164	158
Pravastatin 40 mg Once a Day (QD)	164	157

Primary outcome: Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12

Time frame: Baseline and 12 weeks. Mean (Standard Error). Unit: percent

Measure	Pitavastatin 4 mg Once Daily (QD) n = 161	Pravastatin 40 mg Once Daily (QD) n = 161
Value	-34.8 (1.20)	-22.7 (1.22)

Population analysed: All randomized subjects who took at least 1 dose of double-blind study drug, had a baseline efficacy measurement, and had at least 1 valid post-baseline efficacy measurement.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pitavastatin 4 mg Once a Day (QD)	2 of 164 (1.2%)	19 of 164 (11.6%)	Not reported
Pravastatin 40 mg Once a Day (QD)	1 of 164 (0.6%)	14 of 164 (8.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26922296Miller PE, Martin SS, Joshi PH, Jones SR, Massaro JM, D'Agostino RB, Sponseller CA, Toth PP. Pitavastatin 4 mg Provides Significantly Greater Reduction in Remnant Lipoprotein Cholesterol Compared With Pravastatin 40 mg: Results from the Short-term Phase IV PREVAIL US Trial in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia. Clin Ther. 2016 Mar;38(3):603-9. doi: 10.1016/j.clinthera.2016.02.001. Epub 2016 Feb 26.
Derived from this study: PubMed 24998014Sponseller CA, Morgan RE, Kryzhanovski VA, Campbell SE, Davidson MH. Comparison of the lipid-lowering effects of pitavastatin 4 mg versus pravastatin 40 mg in adults with primary hyperlipidemia or mixed (combined) dyslipidemia: a Phase IV, prospective, US, multicenter, randomized, double-blind, superiority trial. Clin Ther. 2014 Aug 1;36(8):1211-22. doi: 10.1016/j.clinthera.2014.06.009. Epub 2014 Jul 3.
Derived from this study: PubMed 24328357Chapman MJ, Orsoni A, Robillard P, Hounslow N, Sponseller CA, Giral P. Effect of high-dose pitavastatin on glucose homeostasis in patients at elevated risk of new-onset diabetes: insights from the CAPITAIN and PREVAIL-US studies. Curr Med Res Opin. 2014 May;30(5):775-84. doi: 10.1185/03007995.2013.874989. Epub 2014 Jan 10.

Related trials for Primary Dyslipidemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

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.

44 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing pitavastatin and pravastatin in people with Primary Dyslipidemia and Mixed Dyslipidemia, run by Kowa Research Institute, Inc. at 44 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 2 inclusion and 3 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 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12 (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01256476, which also lists 3 linked publications.

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 8 May 2012.