Back to results

Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in Systemic Lupus Erythematosus (SLE) Patients With Corticosteroid Therapy and High Low-Density Lipoprotein (LDL) Cholesterol Level

Primary Purpose

Systemic Lupus Erythematosus, High LDL Cholesterol Level

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Rosuvastatin

Simvastatin

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

SLE patients that on prednisolone more than 30 mg/day
Normal liver faction: AST and ALT < 80 mg/dl
Normal muscle enzyme : CPK < 100 U/L
LDL cholesterol level > 100 mg/dl

Exclusion Criteria:

Patients that was treated with pulse methylprednisolone or corticosteroid equivalent to prednisolone > 1mg/kg/day at screening.
Statin allergy
On statin treatment before screening
On cyclosporine, antifugal (azole group), antibiotics (macrolide group), rifampicin, warfarin, phenytoin
Pregnancy
Abnormal liver function: AST or ALT > 80 mg/dl
Abnormal muscle enzyme : CPK > 300 U/L

Sites / Locations

Faculty of Medicine, Ramathibodi Hospital, Mahidol UniversityRecruiting

Outcomes

Primary Outcome Measures

Percentage reduction of LDL Cholesterol level

Secondary Outcome Measures

Proportion of patients that have transminitis, myositis or active SLE

Full Information

NCT ID

NCT00866229

First Posted

March 19, 2009

Last Updated

March 19, 2009

Sponsor

Ramathibodi Hospital

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00866229

Brief Title

Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in Systemic Lupus Erythematosus (SLE) Patients With Corticosteroid Therapy and High Low-Density Lipoprotein (LDL) Cholesterol Level

Official Title

Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in SLE Patients With Corticosteroid Therapy and High LDL Cholesterol Level

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Unknown status

Study Start Date

April 2008 (undefined)

Primary Completion Date

March 2010 (Anticipated)

Study Completion Date

June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Ramathibodi Hospital

Collaborators

AstraZeneca

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Early statin therapy in SLE patients that have high cholesterol level and other atherosclerosis risk should reduce atherosclerosis and coronary artery events in later course of disease. By the way, statin is used in restricted groups of rheumatologists due to awareness of side effects; myositis and hepatitis, that are frequently found in SLE patients more so than other groups of atherosclerosis patients and reporting data of autoimmune diseases that occur after statin use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus, High LDL Cholesterol Level

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Intervention Description

10 mg per day for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Simvastatin

Intervention Description

20 mg per day

Primary Outcome Measure Information:

Title

Percentage reduction of LDL Cholesterol level

Time Frame

6 and 12 weeks

Secondary Outcome Measure Information:

Title

Proportion of patients that have transminitis, myositis or active SLE

Time Frame

6,12, 18 and 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: SLE patients that on prednisolone more than 30 mg/day Normal liver faction: AST and ALT < 80 mg/dl Normal muscle enzyme : CPK < 100 U/L LDL cholesterol level > 100 mg/dl Exclusion Criteria: Patients that was treated with pulse methylprednisolone or corticosteroid equivalent to prednisolone > 1mg/kg/day at screening. Statin allergy On statin treatment before screening On cyclosporine, antifugal (azole group), antibiotics (macrolide group), rifampicin, warfarin, phenytoin Pregnancy Abnormal liver function: AST or ALT > 80 mg/dl Abnormal muscle enzyme : CPK > 300 U/L

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Parawee Suwannalai, M.D.

Phone

+31614364578

tepwa@mahidol.ac.th

First Name & Middle Initial & Last Name or Official Title & Degree

Piyaporn Sirijanchun, M.D.

Phone

+66816810700

tepsrc@mahidol.ac.th

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Parawee Suwannalai, M.D.

Organizational Affiliation

Ramathibodi Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

City

Bangkok

ZIP/Postal Code

10240

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pintip Ngamjanyaporn, M.D.

Phone

+6622011477

pintiptip@yahoo.com

First Name & Middle Initial & Last Name & Degree

Piyaporn Sirijanchun, M.D.

Phone

+6622011477

tepsrc@mahidol.ac.th

First Name & Middle Initial & Last Name & Degree

Parawee Suwannalai, M.D.

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in Systemic Lupus Erythematosus (SLE) Patients With Corticosteroid Therapy and High Low-Density Lipoprotein (LDL) Cholesterol Level

We'll reach out to this number within 24 hrs