Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome (CAPITAIN)
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ClinicalTrials.gov Identifier: NCT01595828 |
Recruitment Status :
Completed
First Posted : May 10, 2012
Last Update Posted : July 22, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metabolic Syndrome | Drug: Pitavastatin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 : | October 2010 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

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

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Ages Eligible for Study: | 30 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595828
United Kingdom | |
Kowa Research Europe Ltd. | |
Wokingham, United Kingdom |
Responsible Party: | Kowa Research Europe |
ClinicalTrials.gov Identifier: | NCT01595828 |
Other Study ID Numbers: |
NK-104-4.03EU |
First Posted: | May 10, 2012 Key Record Dates |
Last Update Posted: | July 22, 2013 |
Last Verified: | July 2013 |
Metabolic Syndrome Syndrome 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 |