|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00555230 |
|
Date of registration:
|
07/11/2007 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis
|
|
Scientific title:
|
Effects of HMG-coA Reductase Inhibitor on Progression of Carotid Intima-Media Thickness and Arterial Stiffness in Rheumatoid Arthritis |
|
Date of first enrolment:
|
July 2007 |
|
Target sample size:
|
150 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00555230 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Edmund Kwok Ming Li, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Chinese University of Hong Kong |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Men or women, 18 years of age or older
- Clinical diagnosis of RA with a duration of at least 6 month
- Prednisolone < =10 mg/day
- NSAID or DMARD
- Informed consent
Exclusion Criteria:
- Little or no ability for self-care
- Type 1 diabetes mellitus
- Uncontrolled hypertension(> 160/95 mmHg)
- Total cholesterol > 240 mg/dl, current or recent (within the past 3 months)
- History of coronary bypass grafting, myocardial infraction within 28days, left
ventricular dysfunction (ejection fraction < 40%), significant valvular heart disease
- Current treatment with ACE inhibitor, angiotensin II receptor blockers or
beta-blockers, lipid lowering drug, or contra-indication to statins
- Current treatment of oral contraceptives, estrogen and progestin was allowed but
patient not willing to stop during study
- Current treatment with antioxidant therapy (Vitamin C or multivitamin)
- Received intra-articular, intramuscular, or intravenous corticosteroids in the past 4
weeks before screening
- Clinically significant renal disease(serum creatinine level = 270 µmol/L) or
aspartate aminotransferase(AST), alanine aminotransferase ALT), or creatine kinase
(CK)= 2 X ULN
- Female of childbearing potential, unwilling to use adequate contraception during the
study
- Current or recent (within the past 3 months) pregnancy and cancer
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Rheumatoid Arthritis
|
|
Intervention(s)
|
|
Drug: Placebo
|
|
Drug: Rosuvastatin
|
|
Primary Outcome(s)
|
|
Improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV.
[Time Frame: baseline,week24,week52]
|
|
Secondary Outcome(s)
|
|
physical examination,blood pressure,pulse rate,and body weight measurements at each visit.Liver function and CK are performed at baseline,week 12,24 and 52.Correlation between clinical parameters,inflammatory markers and atherosclerosis.
[Time Frame: baseline,week0,week3,week8,week12,week24,week36,week52]
|
|
Secondary ID(s)
|
|
RA-2007-004
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|