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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: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2006-000021-57-DK
Date of registration: 24/02/2006
Prospective Registration: Yes
Primary sponsor: Rigshospitalet
Public title: Bosentan and Sildenfil for patients with Eisenmenger syndrome
Scientific title: Bosentan and Sildenfil for patients with Eisenmenger syndrome
Date of first enrolment: 10/03/2006
Target sample size: 20
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000021-57
Study type:  Interventional clinical trial of medicinal product
Study design:  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  
Phase: 
Countries of recruitment
Denmark
Contacts
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Key inclusion & exclusion criteria
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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).
Intervention(s)

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

Primary Outcome(s)
Primary end point(s): The primary end point is change in physical performance measured with six minutes walking test.
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.
Main Objective: We would like to examine the effect of treating patients with Eisenmengers Syndrome with a combination of Bosentan and Sildenafil.
Secondary Outcome(s)
Secondary ID(s)
01000
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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