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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pitavastatin 4mg daily

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

Group Type EXPERIMENTAL

Pitavastatin

Intervention Type DRUG

Interventions

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Pitavastatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No