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Comparison of Pitavastatin With Atorvastatin in Increasing High Density Lipoprotein - Cholesterol (HDL-C) and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease (CAD) (COMPACT-CAD)

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ClinicalTrials.gov Identifier: NCT00861861
Recruitment Status : Completed
First Posted : March 16, 2009
Last Update Posted : October 14, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to compare the effects of pitavastatin and atorvastatin on adiponectin percentage change in patients with hypercholesteremia comorbid stable CAD.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Coronary Artery Disease Drug: Pitavastatin Drug: Atorvastatin Phase 4

Detailed Description:
The efficiency of lipid lowering therapy was already proven by the clinical trials of statins. According to these results, the target value of LDL-C is recommended under 100mg/dL in the Japan Atherosclerosis Society Guidelines. However, the efficiency of intensive therapy to lower LDL-C more than 100mg/dL has not been proven yet.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Pitavastatin With Atorvastatin in Increasing HDL-C and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease.
Study Start Date : September 2008
Primary Completion Date : October 2013
Study Completion Date : October 2013


Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
pitavastatin group
Drug: Pitavastatin
comparison of two drugs in increasing HDL-C and adiponectin
Active Comparator: 2
atorvastatin group
Drug: Atorvastatin
comparison of two drugs in increasing HDL-C and adiponectin


Outcome Measures

Primary Outcome Measures :
  1. HDL-cholesterol (HDL-C); Adiponectin; High-Molecular- Weight Adiponectin(HMW Adiponectin) [ Time Frame: start, 6 months, 12 months, 30 months ]

Secondary Outcome Measures :
  1. TC; LDL-C; HDL-C; HDL2-C; HDL3-C; TG; smalldenseLDL; MDA-LDL; FPG; HbA1c; Cr; RLP-C; apoA-I; apoB; apoC-Ⅱ; apoC-Ⅲ [ Time Frame: start, 6 months, 12 months, 30 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with dyslipidemia as defined by any of the parameters:

    • HDL-C < 50 mg/dL
    • LDL-C ≥ 140 mg/dL
    • LDL-C ≥ 100 mg/dL and cholesterol-lowering treatment is necessary in accordance with the investigator's judgement
  • Patients who passed three months or more after acute myocardial infarction
  • Patients who passed one month or more after unstable angina
  • Patients who passed one month or more after PCI
  • Patients with written consent by their own volition after being provided sufficient explanation for the participation into this clinical trial

Exclusion Criteria:

  • Patients with any allergy to pitavastatin or atorvastatin
  • Patients with familial hypercholesterolemia
  • Patients receiving pitavastatin
  • Patients with severe hypertension
  • Patients with renal disorders or undergoing dialysis
  • Patients with hepatobiliary disorders
  • Patients with hepatobiliary disorders
  • Patients with family history of hypothyroidism or muscular dystrophy
  • Patients with history of drug-induced hepatic disorder
  • Drug abuser or dipsomaniac
  • Patients with cardiogenic shock.
  • Patients who hopes for pregnancy during this study
  • Contraindications, Relative Contraindications, Absolute Contraindications for Coadministration and Relative Contraindications for Coadministration for pitavastatin or atorvastatin
  • Patients who are ineligible in the opinion of the investigator
Contacts and Locations

Information from the National Library of Medicine

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): NCT00861861


Locations
Japan
Kumamoto University Graduate School of Medical Sciences Department of Cardiocascular Medicine
Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Kumamoto University
Investigators
Principal Investigator: Hisao Ogawa, MD,PhD Kumamoto University Graduate School of Medical Sciences
More Information

Responsible Party: Hisao Ogawa, Kumamoto University
ClinicalTrials.gov Identifier: NCT00861861     History of Changes
Other Study ID Numbers: Kumamoto-746
First Posted: March 16, 2009    Key Record Dates
Last Update Posted: October 14, 2013
Last Verified: October 2013

Keywords provided by Hisao Ogawa, Kumamoto University:
Pitavastatin
Atorvastatin
CAD
HDL-C
Adiponectin

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hypercholesterolemia
Dyslipidemias
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors