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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00120380 |
Date of registration:
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11/07/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH)
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Scientific title:
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Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension |
Date of first enrolment:
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September 2004 |
Target sample size:
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40 |
Recruitment status: |
Terminated |
URL:
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http://clinicaltrials.gov/show/NCT00120380 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Germany
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Contacts
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Name:
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Marius M Hoeper, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Hannover Medical School |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- IPAH
- > 3 months treatment with bosentan
- 6 minute walk distance 150 - 425 m
Exclusion Criteria:
- other forms of pulmonary hypertension
- severe comorbidities
- cotreatment with sildenafil or investigational drugs
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Drug: Aerosolized iloprost
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Drug: Placebo
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Primary Outcome(s)
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6 minute walk test
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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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