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

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).

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kowa Research Europe Ltd.

Wokingham, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pitavastatin

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Kowa Research Europe

Industry

Registry information

Official study 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)

Acronym: CAPITAIN

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: May 10, 2012
Registry last updated: Jul 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed