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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.
Last refreshed on: 19 February 2015
Main ID:  NCT00984932
Date of registration: 24/09/2009
Prospective Registration: No
Primary sponsor: Faculty of Medicine, University of Alexandria
Public title: Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension
Scientific title: The Effect of Rosuvastatin on Vascular Dysfunction and Inflammatory Markers in Systemic Sclerosis-related Pulmonary Hypertension: Randomized, Double-Blind Placebo-Controlled Trial
Date of first enrolment: September 2008
Target sample size: 40
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Name:     Anna Abou-Raya
Affiliation:  University of Alexandria
Key inclusion & exclusion criteria

Inclusion Criteria:

- New York Heart Association (NYHA) class III

- A mean pulmonary artery pressure (mPAP) of > 30mmHg at rest

Exclusion Criteria:

- Smoking

- Diabetes mellitus

- Hypercholesterolemia

- Hypertension

- Cardiac insufficiency

- Coexisting hepatic and renal diseases

- Use of drugs known to interact with statins.

- Patients with severe interstitial lung fibrosis

Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Systemic Sclerosis
Drug: Rosuvastatin
Primary Outcome(s)
exercise capacity measured by the SMWT, mPAP and WHO functional class change [Time Frame: At baseline and After 6 months of therapy]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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