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Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome (CAPITAIN)
This study has been completed.
Sponsor:
Kowa Research Europe
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
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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: | 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
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 ]
| 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 (Adult) |
| Sexes 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01595828
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Additional relevant MeSH terms:
|
Syndrome Metabolic Syndrome X Disease Pathologic Processes Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Pitavastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents |
ClinicalTrials.gov processed this record on June 23, 2017