Metabolic SyndromePhase 4NCT00444717
Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome
A Phase 4 study testing pitavastatin in people with Metabolic Syndrome and Oxidative Stress, run by Aichi Gakuin University at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate anti-oxidative and anti-inflammatory effects of pitavastatin in hypercholesterolemic patients with the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metabolic Syndrome, Oxidative Stress, Inflammation
- What is being tested?
- pitavastatin
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2007to Sep 2008
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypercholesterolemic patients
Who cannot join
- Patients receiving lipid-lowering agents
- Familial hypercholesterolemia
- Renal disease
- Diseases of liver, gallbladder and bile ducts
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Study for Anti-oxidative and Anti-inflammatory Effects of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome
The purpose of this study is to evaluate anti-oxidative and anti-inflammatory effects of pitavastatin in hypercholesterolemic patients with the metabolic syndrome.
Read the detailed description
The metabolic syndrome is defined as a cluster of cardiovascular risk factors including visceral obesity, dyslipidemia, elevated blood pressure and impaired glucose tolerance. Recently, it has been described that oxidative stress and inflammatory reaction, which are important in progression of atherosclerosis, increases in individuals with the metabolic syndrome. Statins might have beneficial effects such as anti-oxidative and anti-inflammatory actions that are independent from their cholesterol-lowering effects. Pitavastatin, a chemically synthesized statin, has potent LDL-cholesterol lowering and also anti-oxidative and anti-inflammatory effects in animal studies. However, the effects of pitavastatin on oxidative stress and inflammatory action in patients with the metabolic syndrome have not been reported.
- Conditions
- Metabolic Syndrome, Oxidative Stress, Inflammation
- Being tested
- pitavastatin
- Keywords
- statin, metabolic syndrome, oxidative stress, inflammation
- Medical subject headings
- Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pitavastatinDrug
Also called livalo
Pitavastatin (2mg/day) was administered for 12 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Thiobarbituric acid reactive substance; high sensitive C-reactive protein
Measured: 12 weeks
Secondary outcomes (3)
Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride;
Measured: 12 weeks
Homeostasis model assessment for insulin resistance; adiponectin;
Measured: 12 weeks
Soluble intercellular adhesion molecule-1
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aichi Gakuin University
- Sponsor type
- University, hospital or other
- Investigators
- Tatsuaki Matsubara, MD, PhD, Principal investigator, Department of Internal Medicine, School of Dentistry, Aichi Gakuin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444717
- Sponsor's protocol ID
- AGU-64
- Status last verified
- Oct 2008
- First submitted
- 7 Mar 2007
- Last updated
- 13 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Matsubara T, Naruse K, Arakawa T, Nakao M, Yokoi K, Oguri M, Marui N, Amano T, Ichimiya S, Ohashi T, Imai K, Sakai S, Sugiyama S, Ishii H, Murohara T. Impact of pitavastatin on high-sensitivity C-reactive protein and adiponectin in hypercholesterolemic patients with the metabolic syndrome: the PREMIUM Study. J Cardiol. 2012 Nov;60(5):389-94. doi: 10.1016/j.jjcc.2012.07.012. Epub 2012 Aug 11.
PubMed 22884685
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study for Anti-oxidative and Anti-inflammatory Effects of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00444717
- Acronym / sponsor ID
- AGU-64
- Conditions
- Metabolic Syndrome, Oxidative Stress, Inflammation
- Keywords
- statin, metabolic syndrome, oxidative stress, inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aichi Gakuin UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 8 Mar 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.
The purpose of this study is to evaluate anti-oxidative and anti-inflammatory effects of pitavastatin in hypercholesterolemic patients with the metabolic syndrome.
Detailed description
The metabolic syndrome is defined as a cluster of cardiovascular risk factors including visceral obesity, dyslipidemia, elevated blood pressure and impaired glucose tolerance. Recently, it has been described that oxidative stress and inflammatory reaction, which are important in progression of atherosclerosis, increases in individuals with the metabolic syndrome. Statins might have beneficial effects such as anti-oxidative and anti-inflammatory actions that are independent from their cholesterol-lowering effects. Pitavastatin, a chemically synthesized statin, has potent LDL-cholesterol lowering and also anti-oxidative and anti-inflammatory effects in animal studies. However, the effects of pitavastatin on oxidative stress and inflammatory action in patients with the metabolic syndrome have not been reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hypercholesterolemic patients
Key exclusion criteria (5 listed)
- Patients receiving lipid-lowering agents
- Familial hypercholesterolemia
- Renal disease
- Diseases of liver, gallbladder and bile ducts
- Pregnant women
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 (2mg/day) was administered for 12 weeks | Drug | – |
Primary outcome
Thiobarbituric acid reactive substance; high sensitive C-reactive protein
Time frame: 12 weeks
3 secondary outcomes
Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride;
Time frame: 12 weeks
Homeostasis model assessment for insulin resistance; adiponectin;
Time frame: 12 weeks
Soluble intercellular adhesion molecule-1
Time frame: 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 13 Jul 2011.
- Derived from this study: PubMed 22884685Matsubara T, Naruse K, Arakawa T, Nakao M, Yokoi K, Oguri M, Marui N, Amano T, Ichimiya S, Ohashi T, Imai K, Sakai S, Sugiyama S, Ishii H, Murohara T. Impact of pitavastatin on high-sensitivity C-reactive protein and adiponectin in hypercholesterolemic patients with the metabolic syndrome: the PREMIUM Study. J Cardiol. 2012 Nov;60(5):389-94. doi: 10.1016/j.jjcc.2012.07.012. Epub 2012 Aug 11.
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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.
Tatsuaki Matsubara, MD, PhD principal investigator
Department of Internal Medicine, School of Dentistry, Aichi Gakuin University
1 site 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 in people with Metabolic Syndrome and Oxidative Stress, run by Aichi Gakuin University at 1 site in Japan.
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 1 inclusion and 5 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 13 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
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?
Thiobarbituric acid reactive substance; high sensitive C-reactive protein (time frame: 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 NCT00444717, which also lists 1 linked publication.
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 13 Jul 2011.