NCT00444717

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

July 13, 2011

Status Verified

October 1, 2008

Enrollment Period

1.4 years

First QC Date

March 7, 2007

Last Update Submit

July 12, 2011

Conditions

Metabolic SyndromeOxidative StressInflammation

Keywords

statinmetabolic syndromeoxidative stressinflammation

Outcome Measures

Primary Outcomes (1)

  • Thiobarbituric acid reactive substance; high sensitive C-reactive protein

    12 weeks

Secondary Outcomes (3)

  • Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride;

    12 weeks

  • Homeostasis model assessment for insulin resistance; adiponectin;

    12 weeks

  • Soluble intercellular adhesion molecule-1

    12 weeks

Interventions

pitavastatinDRUG

Pitavastatin (2mg/day) was administered for 12 weeks

Also known as: livalo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypercholesterolemic patients

You may not qualify if:

  • Patients receiving lipid-lowering agents
  • Familial hypercholesterolemia
  • Renal disease
  • Diseases of liver, gallbladder and bile ducts
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tatsuaki Matsubara

Nagoya, Aichi-ken, 464-8651, Japan

Location

Related Publications (1)

  • 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.

    PMID: 22884685DERIVED

MeSH Terms

Conditions

Metabolic SyndromeInflammation

Interventions

pitavastatin

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tatsuaki Matsubara, MD, PhD

    Department of Internal Medicine, School of Dentistry, Aichi Gakuin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 8, 2007

Study Start

April 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

July 13, 2011

Record last verified: 2008-10

Locations

JP(1)