ClinicalTrials.gg
Sign In
CompletedNCT01595828CAPITAINUpdated Jul 22, 2013

Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome

A Phase 1 interventional study of Pitavastatin in Metabolic Syndrome, sponsored by Kowa Research Europe. Completed at 1 site in United Kingdom. Open to male participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-07-22.

Sponsored by Kowa Research Europe (part of Kowa Company, Ltd.) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
30 Years to 65 Years
Sex
Male
01

Study 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).

02

Conditions studied

  • Metabolic Syndrome

Browse trials for

03

In context

Metabolic Syndrome

2,011 studies on the registry are indexed under Metabolic Syndrome; 334 are open to participants now.

This study's enrollment of 14 is below the median of 60 across 1,494 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Kowa Research Europe is the lead sponsor of 10 studies on the registry; none are open to participants now.

Browse Kowa Research Europe studies →All Kowa Company, Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with metabolic syndrome
  • Patients with LDL-C > 130mg/dL
  • Eligible, able to participate and have given informed consent

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Pitavastatin 4mg daily

    4 mg tablets of pitavastatin by oral route for a period of 6 months

    Drug: Pitavastatin

Interventions

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Kowa Research Europe Ltd.
    Wokingham, United Kingdom
08

References and documents

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 38160756 ↗
  • Therond 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 35695616 ↗
  • Chapman 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 32295829 ↗
  • Chapman 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 29574070 ↗
  • Orsoni 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 27581680 ↗
  • Meikle 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 26486974 ↗
  • 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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2010, a primary completion of Jun 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 2, 2012
First posted
May 10, 2012
Start
Oct 2010
Primary completionActual
Jun 2012
CompletionActual
Jun 2012
Last update
Jul 22, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01595828
Lead sponsor
Kowa Research Europe
Responsible party
Sponsor
First posted
May 10, 2012
Start date
Oct 2010
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Jul 22, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Pitavastatin

Other studies in this condition

Metabolic Syndrome →

Other studies from this sponsor

Kowa Research Europe →

Start the discussion