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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01595828
First Posted: May 10, 2012
Last Update Posted: July 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kowa Research Europe
May 2, 2012
May 10, 2012
July 22, 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 ]
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
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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
Intervention Model: Single Group Assignment
Masking: None (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

*   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
Sexes Eligible for Study: Male
30 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01595828
NK-104-4.03EU
No
Not Provided
Not Provided
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