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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. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2006-000021-57-DK |
Date of registration:
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24/02/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Bosentan and Sildenfil for patients with Eisenmenger syndrome
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Scientific title:
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Bosentan and Sildenfil for patients with Eisenmenger syndrome |
Date of first enrolment:
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10/03/2006 |
Target sample size:
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20 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000021-57 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
Other trial design description: Part 1 of the study is open part 2 is double blind randomized cross-over
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Part 1: Open label Bosentan vs. nothing Part 2: bosentan/placebo vs. Bosentan/Sildenafil
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Phase:
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Countries of recruitment
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Denmark
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Key inclusion & exclusion criteria
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Inclusion criteria: Eisenmenger Syndrome Al least 18 years old Negative pregnancy test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: Raised liver enzymes to more than 3 times normal values. Recently stroke or myocardial infarction(3 months) Allergy to medication
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Eisenmengers syndrome is condition with severe pulmonary arterial hypertension due to a shunting of blood from the left side of the heart to the right side of the heart. When the pressure in the pulmonary arteries levels the systemic blood pressure, blood begins to shunt from the right side of the heart to the left side of the heart leading to a condition with cyanosis, impaired physical capacity and increased mortality (Eisenmengers syndrome).
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Intervention(s)
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Trade Name: Tracleer Product Name: Tracleer Pharmaceutical Form: Tablet Other descriptive name: Bosentan monohydrat
Trade Name: VIAGRA Product Name: Viagra Pharmaceutical Form: Tablet Other descriptive name: sildenafil Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): The primary end point is change in physical performance measured with six minutes walking test.
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Secondary Objective: Secondary end points is change in saturation, NYHA class, cardiac output (cardiac catheterization and inocor measurement), pulmonary vascular resistence (cardiac catheterization) shunt ratio (MRI), strain of right ventricle (BNP and echocardiography) and serum erythropoitin.
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Main Objective: We would like to examine the effect of treating patients with Eisenmengers Syndrome with a combination of Bosentan and Sildenafil.
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Source(s) of Monetary Support
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Results
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Results available:
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