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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kowa Research Europe
ClinicalTrials.gov Identifier:
NCT01595828
First received: May 2, 2012
Last updated: July 19, 2013
Last verified: July 2013

May 2, 2012
July 19, 2013
October 2010
June 2012   (final data collection date for 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 ] [ Designated as safety issue: No ]
Change from baseline to Day 180 in plasma biomarkers of inflammation and atherosclerosis, including monocytes, lymphocytes, endothelial adhesion proteins, atherogenic lipoproteins and cardioprotective HDL
Complete list of historical versions of study NCT01595828 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome
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).

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metabolic Syndrome
Drug: Pitavastatin
Experimental: Pitavastatin 4mg daily
4 mg tablets of pitavastatin by oral route for a period of 6 months
Intervention: Drug: Pitavastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

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
Male
30 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01595828
NK-104-4.03EU
No
Kowa Research Europe
Kowa Research Europe
Not Provided
Not Provided
Kowa Research Europe
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP