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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: |
NCT00593710 |
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Date of registration:
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03/01/2008 |
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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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Losartan Versus Atenolol for the Treatment of Marfan Syndrome
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Scientific title:
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A Randomized Double-blind Study Assessing the Effects of Losartan Versus Atenolol on Pulse Wave Velocity and the Biophysical Properties of the Aorta in Patients With Marfan Syndrome |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00593710 |
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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: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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James E. Potts, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Cornelius van Breemen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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George Sandor, MD, FRCPC |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Subjects must conform to the diagnostic criteria for MFS;
2. Subjects must be between 12 and 25 years;
3. Subjects must have technically suitable echocardiographic windows to obtain the
images needed to calculate the biophysical properties listed as outcome measures;
4. Subjects must provide informed consent and/or assent.
Exclusion Criteria:
1. Patients with significant aortic or mitral valve regurgitation;
2. Patients with a medical condition that would preclude them from taking either of the
study medications or be taken off either medication for a brief period of time;
3. Female patients who are pregnant, planning to become pregnant, or breast-feeding.
Age minimum:
12 Years
Age maximum:
25 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Marfan Syndrome
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Intervention(s)
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Drug: Atenolol
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Drug: Losartan
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Primary Outcome(s)
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Pulse Wave Velocity
[Time Frame: 12 months]
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Secondary Outcome(s)
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Brachial artery reactivity
[Time Frame: 12 months]
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Biophysical properties of the aorta
[Time Frame: 12 months]
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Aortic root dimension and area
[Time Frame: 12 months]
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Secondary ID(s)
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H07-01816
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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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