AzTrials
AzTrials

Arthritis, RheumatoidPhase 2/3NCT00273533

Ramipril in Rheumatoid Arthritis

A Phase 2/3 study testing Ramipril in people with Arthritis, Rheumatoid, run by University of Zurich.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Ramipril
How many people
13 participants
Where
No sites listed yet
Study dates
Jun 2004to Jul 2006
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

About this study

Official title: Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis

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.

Read the 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.

Being tested
Ramipril
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RamiprilDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endothelial dysfunction evaluated on weeks 8 and 16.

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2006 (estimated)
  2. Study startJun 2004
  3. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00273533
Sponsor's protocol ID
HOE498/6007
Status last verified
Oct 2006
First submitted
6 Jan 2006
Last updated
22 Jul 2008
Results posted
No

Publications

  • Flammer AJ, Sudano I, Hermann F, Gay S, Forster A, Neidhart M, Kunzler P, Enseleit F, Periat 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. doi: 10.1161/CIRCULATIONAHA.107.734384. Epub 2008 Apr 21.

    PubMed 18427133

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ramipril in people with Arthritis, Rheumatoid, run by University of Zurich.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endothelial dysfunction evaluated on weeks 8 and 16.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00273533, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2008; AzTrials last refreshed its copy on 4 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in