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

Sponsor

Kowa Research Europe (Industry)

Overall Status

Completed

CT.gov ID

NCT01595828

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Drug: Pitavastatin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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)

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pitavastatin 4mg daily 4 mg tablets of pitavastatin by oral route for a period of 6 months	Drug: Pitavastatin

Arm

Intervention/Treatment

Experimental: Pitavastatin 4mg daily

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

Drug: Pitavastatin

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kowa Research Europe Ltd.	Wokingham		United Kingdom

Sponsors and Collaborators

Kowa Research Europe

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kowa Research Europe

ClinicalTrials.gov Identifier:

NCT01595828

Other Study ID Numbers:

NK-104-4.03EU

First Posted:

May 10, 2012

Last Update Posted:

Jul 22, 2013

Last Verified:

Jul 1, 2013

Additional relevant MeSH terms:

Metabolic Syndrome

Syndrome

Pitavastatin

Study Results

No Results Posted as of Jul 22, 2013