NCT00276133

Brief Summary

Small dense low-density lipoprotein (LDL) plays an important role in causing glomerular injury through conversion to an oxidatively modified form of LDL. However, few studies evaluated the effects of antilipidemic agents on the LDL particle size and renoprotective actions in hyperlipidemic patients with non-diabetic nephropathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2004

Typical duration for phase_4

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

Study Start

First participant enrolled

January 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

May 9, 2007

Status Verified

May 1, 2007

First QC Date

January 11, 2006

Last Update Submit

May 8, 2007

Conditions

Chronic Nephropathy

Keywords

small dense LDL

Outcome Measures

Primary Outcomes (1)

  • Normalization of serum cholesterol concentrations

    One year

Interventions

Effects of atorvastatin versus probucol on small dense LDLDRUG

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hyperlipidemic patients with non-diabetic nephropathy

You may not qualify if:

  • Endocrinological, hematological or hepatic disease
  • Cerebral infarction or hemorrhage
  • Homozygous familial hypercholesterolemia
  • Uncontrolled hypertension
  • Myocardial infarction occurring within the previous 6 months
  • Unstable angina
  • Diabetic nephropathy
  • Abnormal thyroid function
  • Receiving steroids or immunosuppressive agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yokohama City University Center Hospital

Yokohama, Kanagawa, 232-0024, Japan

Location

Related Publications (1)

  • Yasuda G, Kuji T, Hasegawa K, Ogawa N, Shimura G, Ando D, Umemura S. Safety and efficacy of fluvastatin in hyperlipidemic patients with chronic renal disease. Ren Fail. 2004 Jul;26(4):411-8. doi: 10.1081/jdi-120039826.

    PMID: 15462110BACKGROUND

Study Officials

  • Gen Yasuda, MD

    Yokohama City University Center Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 11, 2006

First Posted

January 12, 2006

Study Start

January 1, 2004

Study Completion

May 1, 2007

Last Updated

May 9, 2007

Record last verified: 2007-05

Locations

JP(1)