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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00273533 |
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Date of registration:
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06/01/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ramipril in Rheumatoid Arthritis
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Scientific title:
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Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00273533 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Ali Shokry |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Arthritis, Rheumatoid
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Intervention(s)
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Drug: Ramipril
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Primary Outcome(s)
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Endothelial dysfunction evaluated on weeks 8 and 16.
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Secondary Outcome(s)
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Alteration of inflammatory parameters: C-reactive Protein, TNFa, Interleukin 6 on weeks 8 and 16.
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Secondary ID(s)
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HOE498/6007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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