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| Tracking Information | |||||
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| First Received Date ICMJE | January 6, 2006 | ||||
| Last Updated Date | July 21, 2008 | ||||
| Start Date ICMJE | June 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Endothelial dysfunction evaluated on weeks 8 and 16. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00273533 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Alteration of inflammatory parameters: C-reactive Protein, TNFa, Interleukin 6 on weeks 8 and 16. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ramipril in Rheumatoid Arthritis | ||||
| Official Title ICMJE | Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis | ||||
| 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. |
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| 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 2.5mg in Week1, then 5mg in Week2 followed by 2-5mg for the final 6 weeks) followed by placebo or vice versa.The 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. |
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| Study Phase | Phase II, Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Arthritis, Rheumatoid | ||||
| Intervention ICMJE | Drug: Ramipril | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Flammer AJ, Sudano I, Hermann F, Gay S, Forster A, Neidhart M, Künzler P, Enseleit F, Périat D, Hermann M, Nussberger J, Luscher TF, Corti R, Noll G, Ruschitzka F. Angiotensin-converting enzyme inhibition improves vascular function in rheumatoid arthritis. Circulation. 2008 Apr 29;117(17):2262-9. Epub 2008 Apr 21. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 13 | ||||
| Completion Date | July 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00273533 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | HOE498/6007 | ||||
| Study Sponsor ICMJE | University of Zurich | ||||
| Collaborators ICMJE | Sanofi-Aventis | ||||
| Investigators ICMJE |
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| Information Provided By | University of Zurich | ||||
| Verification Date | October 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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