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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kowa Research Europe

ClinicalTrials.gov Identifier:

NCT01595828

First received: May 2, 2012

Last updated: July 19, 2013

Last verified: July 2013

History of Changes

Purpose

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	Intervention	Phase
Metabolic Syndrome	Drug: Pitavastatin	Phase 1


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Metabolic Syndrome

Drug Information available for: Pitavastatin

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

Further study details as provided by Kowa Research Europe:

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 [ Time Frame: 180 days ] [ Designated as safety issue: No ]


Enrollment:	14
Study Start Date:	October 2010
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pitavastatin 4mg daily 4 mg tablets of pitavastatin by oral route for a period of 6 months	Drug: Pitavastatin

Eligibility


Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595828

Locations


United Kingdom
Kowa Research Europe Ltd.
Wokingham, United Kingdom

Sponsors and Collaborators

Kowa Research Europe

More Information

No publications provided by Kowa Research Europe

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chapman MJ, Orsoni A, Robillard P, Hounslow N, Sponseller CA, Giral P. Effect of high-dose pitavastatin on glucose homeostasis in patients at elevated risk of new-onset diabetes: insights from the CAPITAIN and PREVAIL-US studies. Curr Med Res Opin. 2014 May;30(5):775-84. doi: 10.1185/03007995.2013.874989. Epub 2014 Jan 10.


Responsible Party:	Kowa Research Europe
ClinicalTrials.gov Identifier:	NCT01595828 History of Changes
Other Study ID Numbers:	NK-104-4.03EU
Study First Received:	May 2, 2012
Last Updated:	July 19, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:


Metabolic Syndrome X Syndrome Disease Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Pathologic Processes Pitavastatin	Anticholesteremic Agents Antimetabolites Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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