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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: |
NCT00303004 |
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Date of registration:
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14/03/2006 |
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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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Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome
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Scientific title:
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Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00303004 |
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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: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Lars Soendergaard, 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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Rigshospitalet, Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Eisenmenger syndrome
- Negative pregnancy test
Exclusion Criteria:
- Elevated liver enzymes to more than 3´times normal value
- Hypotension (SBP < 90 mmhg).
- Mandatory treatment with nitrates
- Myocardial infarction within 3 months
- Stroke within 3 months
- Known allergy to Bosentan or Sildenafil
- inherited degenerative diseases in retina
- Breast feeding
- Suspicion of risc of noncompliance.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Eisenmenger Syndrome
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Intervention(s)
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Drug: Bosentan and Sildenafil
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Primary Outcome(s)
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6 minutes walking distance
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Secondary Outcome(s)
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Pulmonary blood flow
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Right ventricle systolic and diastolic function
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Systemic blood flow
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Working capacity
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Oxygen consumption at rest
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Erythropoitin
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Oxygen consumption during maximal work
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Pulmonary resistance
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Saturation in activity
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Quality of life
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BNP
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Saturation in rest
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Shunt ratio
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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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