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

Metabolic Syndrome Clinical Trial

— CAPITAIN  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01595828
• Other study ID #: NK-104-4.03EU
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2012
• Last updated: July 19, 2013
• Start date: October 2010
• Est. completion date: June 2012

Study information

• Verified date: July 2013
• Source: Kowa Research Europe
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Pitavastatin

Locations

Country	Name	City	State
United Kingdom	Kowa Research Europe Ltd.	Wokingham

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Europe

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to Day 180 in plasma biomarkers of inflammation and atherosclerosis, including monocytes, lymphocytes, endothelial adhesion proteins, atherogenic lipoproteins and cardioprotective HDL		180 days	No