Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by:
Aichi Gakuin University
ClinicalTrials.gov Identifier:
NCT00444717
First received: March 7, 2007
Last updated: July 12, 2011
Last verified: October 2008

March 7, 2007
July 12, 2011
April 2007
September 2008   (final data collection date for primary outcome measure)
Thiobarbituric acid reactive substance; high sensitive C-reactive protein [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Thiobarbituric acid reactive substance; high sensitive C-reactive protein
Complete list of historical versions of study NCT00444717 on ClinicalTrials.gov Archive Site
  • Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride; [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Homeostasis model assessment for insulin resistance; adiponectin; [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Soluble intercellular adhesion molecule-1 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride;
  • Homeostasis model assessment for insulin resistance; adiponectin;
  • Soluble intercellular adhesion molecule-1
Not Provided
Not Provided
 
Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome
Multicenter Study for Anti-oxidative and Anti-inflammatory Effects of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

The purpose of this study is to evaluate anti-oxidative and anti-inflammatory effects of pitavastatin in hypercholesterolemic patients with the metabolic syndrome.

The metabolic syndrome is defined as a cluster of cardiovascular risk factors including visceral obesity, dyslipidemia, elevated blood pressure and impaired glucose tolerance. Recently, it has been described that oxidative stress and inflammatory reaction, which are important in progression of atherosclerosis, increases in individuals with the metabolic syndrome. Statins might have beneficial effects such as anti-oxidative and anti-inflammatory actions that are independent from their cholesterol-lowering effects. Pitavastatin, a chemically synthesized statin, has potent LDL-cholesterol lowering and also anti-oxidative and anti-inflammatory effects in animal studies. However, the effects of pitavastatin on oxidative stress and inflammatory action in patients with the metabolic syndrome have not been reported.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metabolic Syndrome
  • Oxidative Stress
  • Inflammation
Drug: pitavastatin
Pitavastatin (2mg/day) was administered for 12 weeks
Other Name: livalo
Not Provided
Matsubara T, Naruse K, Arakawa T, Nakao M, Yokoi K, Oguri M, Marui N, Amano T, Ichimiya S, Ohashi T, Imai K, Sakai S, Sugiyama S, Ishii H, Murohara T. Impact of pitavastatin on high-sensitivity C-reactive protein and adiponectin in hypercholesterolemic patients with the metabolic syndrome: the PREMIUM Study. J Cardiol. 2012 Nov;60(5):389-94. doi: 10.1016/j.jjcc.2012.07.012. Epub 2012 Aug 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hypercholesterolemic patients

Exclusion Criteria:

  • Patients receiving lipid-lowering agents
  • Familial hypercholesterolemia
  • Renal disease
  • Diseases of liver, gallbladder and bile ducts
  • Pregnant women
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00444717
AGU-64
Yes
Tatsuaki Matsubara, Department of Internal Medicine, School of Dentistry, Aichi Gakuin University
Aichi Gakuin University
Not Provided
Principal Investigator: Tatsuaki Matsubara, MD, PhD Department of Internal Medicine, School of Dentistry, Aichi Gakuin University
Aichi Gakuin University
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP