Text Size

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

This study is currently recruiting participants.
Verified May 2012 by Kowa Research Europe
Sponsor:
Information provided by (Responsible Party):
Kowa Research Europe
ClinicalTrials.gov Identifier:
NCT01595828
First received: May 2, 2012
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Metabolic Syndrome
 Drug: Pitavastatin
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kowa Research Europe:

Primary Outcome Measures:
  • Change from baseline to Day 180 in plasma biomarkers of inflammation and atherosclerosis, including monocytes, lymphocytes, endothelial adhesion proteins, atherogenic lipoproteins and cardioprotective HDL

Estimated Enrollment: 20
Arms Assigned Interventions
Experimental: Pitavastatin 4mg daily Drug: Pitavastatin

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Male
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595828

Contacts
Contact: Neil Hounslow, MRCP FFPM +44(0)1189229000

Locations
United Kingdom
Kowa Research Europe Ltd. Recruiting
Wokingham, United Kingdom
Contact: Neil Hounslow, MRCP FFPM            
Sponsors and Collaborators
Kowa Research Europe
  More Information

No publications provided

Responsible Party: Kowa Research Europe
ClinicalTrials.gov Identifier: NCT01595828     History of Changes
Other Study ID Numbers: NK-104-4.03EU
Study First Received: May 2, 2012
Last Updated: May 8, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013