Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273533
Status:
COMPLETED
Last Update Posted:
2008-07-22
First Post:
2006-01-06
Brief Title:
Ramipril in Rheumatoid Arthritis
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study is designed to evaluate the hypothesis that the Angiotensin-Converting Enzyme ACE inhibitor Ramipril improves vascular function and reduces markers of low-grade chronic inflammation and oxidative stress in patients with Rheumatoid Arthritis
Detailed Description:
The effect of an 8-week treatment with either ramipril or placebo is studied using a randomized double-blind and crossover protocol After given written informed consent baseline characteristics including physical examination ECG blood sample and a noninvasive assessment of endothelial function are obtained The patients are randomly assigned to receive either ramipril 10mg up-titration-scheme starting with 25mg in Week1 then 5mg in Week2 followed by 2-5mg for the final 6 weeks followed by placebo or vice versaThe individual disease-modifying antirheumatic drug therapy is continued throughout the study The examinations are repeated after 8 weeks treatment of the first and 8 weeks after the second study drug At week 1 and 2 in each treatment period a safety visit is scheduled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None