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Ramipril in Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00273533
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : July 22, 2008
Sponsor:
Collaborator:
Sanofi
Information provided by:
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: Ramipril Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis
Study Start Date : June 2004
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Ramipril




Primary Outcome Measures :
  1. Endothelial dysfunction evaluated on weeks 8 and 16.

Secondary Outcome Measures :
  1. Alteration of inflammatory parameters: C-reactive Protein, TNFa, Interleukin 6 on weeks 8 and 16.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with rheumatoid arthritis (4 out of 7 ARA criteria must be fulfilled to establish diagnosis) on stable background therapy for the last three months
  • endothelial dysfunction (FMD < 4%, FMD:Flow-Mediated-Dilatation)
  • non-smokers

Exclusion Criteria:

  • previous myocardial infarction, coronary intervention or coronary surgery
  • previous treatment with statins in the last 6 months
  • previous treatment with ACE-inhibitors in the last 6 months
  • uncontrolled hypertension SAP/DAP > 160/90 mmHg (SAP:Systolic Arterial Pressure, DAP:Diastolic Arterial Pressure)
  • dyslipidemia (LDL-cholesterol > 4.9 mmol)
  • normal CRP < 3 mg/l
  • overweight BMI > 35kg/m2
  • anaemia (hemoglobin < 10g/dl)
  • kidney disease (creatinine > 150 umol/l)
  • insulin-dependent diabetes mellitus
  • congestive heart failure (> NYHA I)
  • AV-Block>I
  • pregnancy
  • angio-edema
  • malignancy or chronic infection
  • drug abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273533


Sponsors and Collaborators
University of Zurich
Sanofi
Investigators
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Study Director: Ali Shokry Sanofi
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00273533    
Other Study ID Numbers: HOE498/6007
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: July 22, 2008
Last Verified: October 2006
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents