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

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ClinicalTrials.gov Identifier: NCT01595828
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : July 22, 2013
Sponsor:
Information provided by (Responsible Party):
Kowa Research Europe

Tracking Information
First Submitted Date  ICMJE May 2, 2012
First Posted Date  ICMJE May 10, 2012
Last Update Posted Date July 22, 2013
Study Start Date  ICMJE October 2010
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2013)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
Change from baseline to Day 180 in plasma biomarkers of inflammation and atherosclerosis, including monocytes, lymphocytes, endothelial adhesion proteins, atherogenic lipoproteins and cardioprotective HDL
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome
Official Title  ICMJE 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)
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE Drug: Pitavastatin
Study Arms  ICMJE Experimental: Pitavastatin 4mg daily
4 mg tablets of pitavastatin by oral route for a period of 6 months
Intervention: Drug: Pitavastatin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2013)
14
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2012)
20
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01595828
Other Study ID Numbers  ICMJE NK-104-4.03EU
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kowa Research Europe
Study Sponsor  ICMJE Kowa Research Europe
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kowa Research Europe
Verification Date July 2013

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