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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Locations near you
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Full eligibility criteria for NCT01595828
Ages eligible for Study
30 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
Patients with metabolic syndrome
Patients with LDL-C > 130mg/dL
Eligible, able to participate and have given informed consent
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
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
All locations for NCT01595828
United Kingdom (1)
Kowa Research Europe Ltd.
Wokingham, United Kingdom
View full eligibility
Tris trial is registered with FDA with number: NCT01595828. The sponsor of the trial is Kowa Research Europe and it is looking for 14 volunteers for the current phase.
Official trial 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)
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