DyslipidemiaPhase 4NCT01301066

A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects

A Phase 4 study testing Pitavastatin and Pravastatin in people with Dyslipidemia, run by Kowa Research Institute, Inc. at 35 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

A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Dyslipidemia
What is being tested?: Pitavastatin and Pravastatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 252 participants
Where: 35 sitesUnited States
Study dates: Dec 2010to Mar 2013
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females (non-pregnant, non-lactating females) 18-70 years of age, inclusive, at time of consent.
Both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age >40 years without menses for ≥2 years) must agree to use at least 2 reliable forms of contraception
Documented HIV infection.

Who cannot join

Homozygous familial hypercholesterolemia
Any conditions that may cause secondary dyslipidemia
History of coronary artery disease (CAD) or CAD equivalent

Trial locations and contacts

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

United States35 sites

Study site
Addison, Texas
Study site
Annandale, Virginia
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Berkley, Michigan
Study site
Beverly Hills, California
Study site
Coral Gables, Florida
Study site
Corpus Christi, Texas
Study site
Costa Mesa, California
Study site
Decatur, Georgia
Study site
Fort Lauderdale, Florida
Study site
Fort Worth, Texas
Study site
Ft. Pierce, Florida
Study site
Harlingen, Texas
Study site
Hillsborough, New Jersey
Study site
Houston, Texas
Study site
Huntersville, North Carolina
Study site
Long Beach, California
Study site
Longview, Texas
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
Miami Beach, Florida
Study site
New York, New York
Study site
Newport Beach, California
Study site
Phoenix, Arizona
Study site
Randolph Township, New Jersey
Study site
Rochester, New York
Study site
San Francisco, California
Study site
Seattle, Washington
Study site
Spokane, Washington
Study site
Springfield, Massachusetts
Study site
St Louis, Missouri
Study site
Tampa, Florida
Study site
Vero Beach, Florida
Study site
Washington D.C., District of Columbia

Other trials in United States

About this study

Official title: A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects With Dyslipidemia, Followed by a 40-Week Safety Extension Study

A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.

Conditions: Dyslipidemia
Being tested: Pitavastatin, Pravastatin
Medical subject headings: Dyslipidemias

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 QD
PravastatinDrug
Pravastatin 40 mg QD

Study groups in NCT01301066
Study group	Role	What they receive
Pitavastatin 4 mg QD	Experimental	Not described Receives: Drug: Pitavastatin
Pravastatin 40 mg 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.

Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks
Measured: 12 weeks minus baseline

Timeline

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

Dec 2010Mar 2013

First posted23 Feb 2011 (estimated)
Study startDec 2010
Primary completionMar 2013
Study completionMar 2013

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 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: 252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01301066
Sponsor's protocol ID: NK-104-4.05US
Status last verified: Mar 2014
First submitted: 18 Feb 2011
Last updated: 29 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Aberg JA, Sponseller CA, Ward DJ, Kryzhanovski VA, Campbell SE, Thompson MA. Pitavastatin versus pravastatin in adults with HIV-1 infection and dyslipidaemia (INTREPID): 12 week and 52 week results of a phase 4, multicentre, randomised, double-blind, superiority trial. Lancet HIV. 2017 Jul;4(7):e284-e294. doi: 10.1016/S2352-3018(17)30075-9. Epub 2017 Apr 13.
PubMed 28416195
Toribio M, Fitch KV, Sanchez L, Burdo TH, Williams KC, Sponseller CA, McCurdy Pate M, Aberg JA, Zanni MV, Grinspoon SK. Effects of pitavastatin and pravastatin on markers of immune activation and arterial inflammation in HIV. AIDS. 2017 Mar 27;31(6):797-806. doi: 10.1097/QAD.0000000000001427.
PubMed 28252528
Joshi PH, Miller PE, Martin SS, Jones SR, Massaro JM, D'Agostino RB Sr, Kulkarni KR, Sponseller C, Toth PP. Greater remnant lipoprotein cholesterol reduction with pitavastatin compared with pravastatin in HIV-infected patients. AIDS. 2017 Apr 24;31(7):965-971. doi: 10.1097/QAD.0000000000001423.
PubMed 28121706

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

Recruiting
Effects of Pitavastatin or Combination of Pitavastatin and Ezetimibe on Glucose Metabolism Compared to AtoRvastatin in atheroscLerotic Cardiovascular Disease Patients With Metabolic Syndrome: The EZ-PEARL Randomized Trial
Dyslipidemias, Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)
Hyperlipidemia, Hypercholesterolemia
Recruiting
Pharmacogenomic Informed Statin Prescribing
Hypercholesterolemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population

All Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects With Dyslipidemia, Followed by a 40-Week Safety Extension Study
ClinicalTrials.gov ID: NCT01301066
Acronym / sponsor ID: NK-104-4.05US
Conditions: Dyslipidemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 252 participants (actual)
Lead sponsor: Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
Collaborators: Kowa Pharmaceuticals America, Inc., Eli Lilly and Company
Study start: Dec 2010
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 23 Feb 2011 (estimated)
Results: Posted 29 Apr 2014

Clinical summary

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

A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.

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 QD	Experimental	Drug: Pitavastatin
Pravastatin 40 mg QD	Active comparator	Drug: Pravastatin

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Males and females (non-pregnant, non-lactating females) 18-70 years of age, inclusive, at time of consent.
Both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age >40 years without menses for ≥2 years) must agree to use at least 2 reliable forms of contraception
Documented HIV infection.

Key exclusion criteria (3 listed)

Homozygous familial hypercholesterolemia
Any conditions that may cause secondary dyslipidemia
History of coronary artery disease (CAD) or CAD equivalent

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 QD	Drug	Pitavastatin 4 mg QD
PravastatinPravastatin 40 mg QD	Drug	Pravastatin 40 mg QD

Primary outcome

Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks
Time frame: 12 weeks minus baseline

Results and safety

Results posted to the registry on 29 Apr 2014, 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 QD	126	99
Pravastatin 40 mg QD	126	91

Primary outcome: Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks

Time frame: 12 weeks minus baseline. Mean (Standard Deviation). Unit: mg/dL

Measure	Pitavastatin 4 mg QD n = 121	Pravastatin 40 mg QD n = 126
Value	155.1 (25.93)	154.6 (23.91)

Population analysed: modified Intent To Treat (mITT) population included all randomized subjects who received at least 1 dose of study drug and had at least 1 on-treatment lipid assessment

Adverse events

Other adverse events reported at 1.6% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pitavastatin 4 mg QD	7 of 126 (5.6%)	10 of 126 (7.9%)	Not reported
Pravastatin 40 mg QD	3 of 126 (2.4%)	5 of 126 (4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28416195Aberg JA, Sponseller CA, Ward DJ, Kryzhanovski VA, Campbell SE, Thompson MA. Pitavastatin versus pravastatin in adults with HIV-1 infection and dyslipidaemia (INTREPID): 12 week and 52 week results of a phase 4, multicentre, randomised, double-blind, superiority trial. Lancet HIV. 2017 Jul;4(7):e284-e294. doi: 10.1016/S2352-3018(17)30075-9. Epub 2017 Apr 13.
Derived from this study: PubMed 28252528Toribio M, Fitch KV, Sanchez L, Burdo TH, Williams KC, Sponseller CA, McCurdy Pate M, Aberg JA, Zanni MV, Grinspoon SK. Effects of pitavastatin and pravastatin on markers of immune activation and arterial inflammation in HIV. AIDS. 2017 Mar 27;31(6):797-806. doi: 10.1097/QAD.0000000000001427.
Derived from this study: PubMed 28121706Joshi PH, Miller PE, Martin SS, Jones SR, Massaro JM, D'Agostino RB Sr, Kulkarni KR, Sponseller C, Toth PP. Greater remnant lipoprotein cholesterol reduction with pitavastatin compared with pravastatin in HIV-infected patients. AIDS. 2017 Apr 24;31(7):965-971. doi: 10.1097/QAD.0000000000001423.

Related trials for Dyslipidemia

Recruiting
Effects of Pitavastatin or Combination of Pitavastatin and Ezetimibe on Glucose Metabolism Compared to AtoRvastatin in atheroscLerotic Cardiovascular Disease Patients With Metabolic Syndrome: The EZ-PEARL Randomized Trial
Dyslipidemias, Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)
Hyperlipidemia, Hypercholesterolemia
Recruiting
Pharmacogenomic Informed Statin Prescribing
Hypercholesterolemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population

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.

35 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 Dyslipidemia, run by Kowa Research Institute, Inc. at 35 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 3 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 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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 29 Apr 2014). 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?

Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks (time frame: 12 weeks minus baseline). 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 NCT01301066, 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 29 Apr 2014.