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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01595828

Acronym

CAPITAIN

Enrollment

Registered

2012-05-10

Start date

2010-10-31

Completion date

2012-06-30

Last updated

2013-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

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).

Interventions

DRUGPitavastatin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

30 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026