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

Phase 1

Completed

• Conditions: Metabolic Syndrome
• Interventions: Drug: Pitavastatin

• Registration Number: NCT01595828
• Lead Sponsor: Kowa Research Europe

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 available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-05-02
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-10
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-19
• Last Update Posted: 2013-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pitavastatin 4mg daily	Pitavastatin	4 mg tablets of pitavastatin by oral route for a period of 6 months

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kowa Research Europe Ltd.; 🇬🇧 Wokingham, United Kingdom