Trial record 14 of 93 for:    "ACDC"

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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hisao Ogawa, Kumamoto University
ClinicalTrials.gov Identifier:
NCT00861861
First received: March 12, 2009
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Hypercholesterolemia
Coronary Artery Disease
Drug: Pitavastatin
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Kumamoto University:

Primary Outcome Measures:
  • HDL-cholesterol (HDL-C); Adiponectin; High-Molecular- Weight Adiponectin(HMW Adiponectin) [ Time Frame: start, 6 months, 12 months, 30 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 129
Study Start Date: September 2008
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
pitavastatin group
Drug: Pitavastatin
comparison of two drugs in increasing HDL-C and adiponectin
Other Name: Pitavastatin
Active Comparator: 2
atorvastatin group
Drug: Atorvastatin
comparison of two drugs in increasing HDL-C and adiponectin
Other Name: Atorvastatin

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Hisao Ogawa, Kumamoto University
ClinicalTrials.gov Identifier: NCT00861861     History of Changes
Other Study ID Numbers: Kumamoto-746
Study First Received: March 12, 2009
Last Updated: October 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by 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
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014