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NCT00668343 Clinical Trial

Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to Placebo

Relapsing Remitting Multiple Sclerosis Clinical Trial

— irmsrct  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00668343
Other study ID # 132/9388
Secondary ID 83/132/9388
Status Completed
Phase Phase 3
First received April 27, 2008
Last updated July 29, 2010
Start date April 2005
Est. completion date March 2009

Study information
Verified date July 2010
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

Patient with relapsing remitting multiple sclerosis taking avonex are included in this double blind randomized control trial. Simvastatin is compared to placebo. end points of edss , total attack, new enhancing lesion and newt2 lesion in mri is evaluated as end point.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date March 2009
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 60 Years
Eligibility Inclusion Criteria:

1. edss<5

2. >=1 attack in last year

Exclusion Criteria:

1. >2 attacks in study

2. drug complication

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• simvastatin
40 mg/ day
• placebo
80 mg /day

Locations
Country Name City State
Iran, Islamic Republic of Sanaz Ahmadi Tehran

Sponsors (1)
Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary attack number 1 year No
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