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

Kowa

Status and phase: Completed; Phase 1

Conditions: Metabolic Syndrome

Treatments: Drug: Pitavastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01595828

NK-104-4.03EU

Details and patient eligibility

About

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).

Enrollment: 14 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Pitavastatin 4mg daily

Experimental group

Description:

4 mg tablets of pitavastatin by oral route for a period of 6 months

Treatment:

Drug: Pitavastatin