Metabolic SyndromePhase 1CAPITAINNCT01595828
Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome
A Phase 1 study testing Pitavastatin in people with Metabolic Syndrome, run by Kowa Research Europe at 1 site in United Kingdom.
Trial summary
The purpose of this study is to examine in detail the acute and chronic effects of pitavastatin on plasma lipid transport and atheroma biomarkers in patients at elevated risk for the premature development of atherosclerosis (CAPITAIN). Read more about this study
- Who is it for?
- Ages 30 to 65 years, men only
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Pitavastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to Jun 2012
- Phase
- Phase 1
- 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 30 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with metabolic syndrome
- Patients with LDL-C > 130mg/dL
- Eligible, able to participate and have given informed consent
Who cannot join
- Body Mass Index >35 kg/m2
- LDL-C > 190mg/dL
- Fasting triglycerides > 400 mg/dL
- Diabetes mellitus (fasting glucose >7 mmol/L) or taking diabetic therapy
- Uncontrolled hypertension (Systolic Blood Pressure >= 140 mmHg or Diastolic Blood Pressure >= 90mmHg)
- Any conditions that cause secondary dyslipidaemia or increase the risk of statin therapy
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- ALAT and ASAT >3 x ULRR
- Impaired renal function (Serum Creatinine >1.5 x ULRR or eGFR <60 mL/min)
- History of any muscle disease or unexplained elevation (>3 x ULRR) of serum creatine kinase
- Evidence of symptomatic heart failure (NYHA class III or IV)
- Current or recent user of supplements or medications known to alter lipid metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study of the Chronic and Acute Effects of Pitavastatin on Monocyte Phenotype, Endothelial Dysfunction and HDL Atheroprotective Function in Subjects With Metabolic Syndrome (CAPITAIN)
The purpose of this study is to examine in detail the acute and chronic effects of pitavastatin on plasma lipid transport and atheroma biomarkers in patients at elevated risk for the premature development of atherosclerosis (CAPITAIN).
- Conditions
- Metabolic Syndrome
- Being tested
- Pitavastatin
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin 4mg daily | Experimental | 4 mg tablets of pitavastatin by oral route for a period of 6 months Receives: Drug: Pitavastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Day 180 in plasma biomarkers of inflammation and atherosclerosis, including monocytes, lymphocytes, endothelial adhesion proteins, atherogenic lipoproteins and cardioprotective HDL
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startOct 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Europe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595828
- Sponsor's protocol ID
- NK-104-4.03EU
- Acronym
- CAPITAIN
- Status last verified
- Jul 2013
- First submitted
- 2 May 2012
- Last updated
- 22 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Chapman MJ, Orsoni A, Mellett NA, Nguyen A, Robillard P, Shaw JE, Giral P, Therond P, Swertfeger D, Davidson WS, Meikle PJ. Pitavastatin treatment remodels the HDL subclass lipidome and proteome in hypertriglyceridemia. J Lipid Res. 2024 Feb;65(2):100494. doi: 10.1016/j.jlr.2023.100494. Epub 2023 Dec 29.
PubMed 38160756Therond P, Chapman MJ. Sphingosine-1-phosphate: metabolism, transport, atheroprotection and effect of statin treatment. Curr Opin Lipidol. 2022 Jun 1;33(3):199-207. doi: 10.1097/MOL.0000000000000825. Epub 2022 Mar 9.
PubMed 35695616Chapman MJ, Orsoni A, Tan R, Mellett NA, Nguyen A, Robillard P, Giral P, Therond P, Meikle PJ. LDL subclass lipidomics in atherogenic dyslipidemia: effect of statin therapy on bioactive lipids and dense LDL. J Lipid Res. 2020 Jun;61(6):911-932. doi: 10.1194/jlr.P119000543. Epub 2020 Apr 15.
PubMed 32295829Chapman MJ, Orsoni A, Robillard P, Therond P, Giral P. Duality of statin action on lipoprotein subpopulations in the mixed dyslipidemia of metabolic syndrome: Quantity vs quality over time and implication of CETP. J Clin Lipidol. 2018 May-Jun;12(3):784-800.e4. doi: 10.1016/j.jacl.2018.02.001. Epub 2018 Feb 9.
PubMed 29574070Orsoni A, Therond P, Tan R, Giral P, Robillard P, Kontush A, Meikle PJ, Chapman MJ. Statin action enriches HDL3 in polyunsaturated phospholipids and plasmalogens and reduces LDL-derived phospholipid hydroperoxides in atherogenic mixed dyslipidemia. J Lipid Res. 2016 Nov;57(11):2073-2087. doi: 10.1194/jlr.P068585. Epub 2016 Aug 31.
PubMed 27581680Meikle PJ, Wong G, Tan R, Giral P, Robillard P, Orsoni A, Hounslow N, Magliano DJ, Shaw JE, Curran JE, Blangero J, Kingwell BA, Chapman MJ. Statin action favors normalization of the plasma lipidome in the atherogenic mixed dyslipidemia of MetS: potential relevance to statin-associated dysglycemia. J Lipid Res. 2015 Dec;56(12):2381-92. doi: 10.1194/jlr.P061143. Epub 2015 Oct 20.
PubMed 26486974Chapman 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of the Chronic and Acute Effects of Pitavastatin on Monocyte Phenotype, Endothelial Dysfunction and HDL Atheroprotective Function in Subjects With Metabolic Syndrome (CAPITAIN)
- ClinicalTrials.gov ID
- NCT01595828
- Acronym / sponsor ID
- CAPITAIN / NK-104-4.03EU
- Conditions
- Metabolic Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Kowa Research EuropeIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 May 2012 (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 examine in detail the acute and chronic effects of pitavastatin on plasma lipid transport and atheroma biomarkers in patients at elevated risk for the premature development of atherosclerosis (CAPITAIN).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin 4mg daily | Experimental | Drug: Pitavastatin4 mg tablets of pitavastatin by oral route for a period of 6 months |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with metabolic syndrome
- Patients with LDL-C > 130mg/dL
- Eligible, able to participate and have given informed consent
Key exclusion criteria (11 listed)
- Body Mass Index >35 kg/m2
- LDL-C > 190mg/dL
- Fasting triglycerides > 400 mg/dL
- Diabetes mellitus (fasting glucose >7 mmol/L) or taking diabetic therapy
- Uncontrolled hypertension (Systolic Blood Pressure >= 140 mmHg or Diastolic Blood Pressure >= 90mmHg)
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 |
|---|---|---|
| Pitavastatin | Drug | Pitavastatin 4mg daily |
Primary outcome
Change from baseline to Day 180 in plasma biomarkers of inflammation and atherosclerosis, including monocytes, lymphocytes, endothelial adhesion proteins, atherogenic lipoproteins and cardioprotective HDL
Time frame: 180 days
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 22 Jul 2013.
- Derived from this study: PubMed 38160756Chapman MJ, Orsoni A, Mellett NA, Nguyen A, Robillard P, Shaw JE, Giral P, Therond P, Swertfeger D, Davidson WS, Meikle PJ. Pitavastatin treatment remodels the HDL subclass lipidome and proteome in hypertriglyceridemia. J Lipid Res. 2024 Feb;65(2):100494. doi: 10.1016/j.jlr.2023.100494. Epub 2023 Dec 29.
- Derived from this study: PubMed 35695616Therond P, Chapman MJ. Sphingosine-1-phosphate: metabolism, transport, atheroprotection and effect of statin treatment. Curr Opin Lipidol. 2022 Jun 1;33(3):199-207. doi: 10.1097/MOL.0000000000000825. Epub 2022 Mar 9.
- Derived from this study: PubMed 32295829Chapman MJ, Orsoni A, Tan R, Mellett NA, Nguyen A, Robillard P, Giral P, Therond P, Meikle PJ. LDL subclass lipidomics in atherogenic dyslipidemia: effect of statin therapy on bioactive lipids and dense LDL. J Lipid Res. 2020 Jun;61(6):911-932. doi: 10.1194/jlr.P119000543. Epub 2020 Apr 15.
- Derived from this study: PubMed 29574070Chapman MJ, Orsoni A, Robillard P, Therond P, Giral P. Duality of statin action on lipoprotein subpopulations in the mixed dyslipidemia of metabolic syndrome: Quantity vs quality over time and implication of CETP. J Clin Lipidol. 2018 May-Jun;12(3):784-800.e4. doi: 10.1016/j.jacl.2018.02.001. Epub 2018 Feb 9.
- Derived from this study: PubMed 27581680Orsoni A, Therond P, Tan R, Giral P, Robillard P, Kontush A, Meikle PJ, Chapman MJ. Statin action enriches HDL3 in polyunsaturated phospholipids and plasmalogens and reduces LDL-derived phospholipid hydroperoxides in atherogenic mixed dyslipidemia. J Lipid Res. 2016 Nov;57(11):2073-2087. doi: 10.1194/jlr.P068585. Epub 2016 Aug 31.
- Derived from this study: PubMed 26486974Meikle PJ, Wong G, Tan R, Giral P, Robillard P, Orsoni A, Hounslow N, Magliano DJ, Shaw JE, Curran JE, Blangero J, Kingwell BA, Chapman MJ. Statin action favors normalization of the plasma lipidome in the atherogenic mixed dyslipidemia of MetS: potential relevance to statin-associated dysglycemia. J Lipid Res. 2015 Dec;56(12):2381-92. doi: 10.1194/jlr.P061143. Epub 2015 Oct 20.
- 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pitavastatin in people with Metabolic Syndrome, run by Kowa Research Europe at 1 site in United Kingdom.
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 11 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 22 Jul 2013. 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 United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change from baseline to Day 180 in plasma biomarkers of inflammation and atherosclerosis, including monocytes, lymphocytes, endothelial adhesion proteins, atherogenic lipoproteins and cardioprotective HDL (time frame: 180 days). 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 NCT01595828, which also lists 7 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 22 Jul 2013.