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: |
NCT00086463 |
Date of registration:
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01/07/2004 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH)
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Scientific title:
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A Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAH |
Date of first enrolment:
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June 2004 |
Target sample size:
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60 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00086463 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, 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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United States
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Contacts
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Name:
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Henry Hsu, M.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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CoTherix |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of PAH due to PPH, connective tissue disease, HIV, or repaired (= 1 year)
ASD, VSD, or PDA
- NYHA Functional Class III or IV
- On bosentan for at least 16 weeks, with the dose stable (maximum dose 125 mg BID) for
at least 8 weeks
- Age 12-75 years, of either gender
- Six minute walk distance 100-425 meters at Baseline
Exclusion Criteria:
- Any new long-term treatment for PAH added within the last 4 weeks
- Any therapy with a PDE (phosphodiesterase), L -arginine or a prostaglandin,
concurrently, or within the last 4 weeks
- PAH related to chronic thromboembolic disease, portopulmonary disease, or any
etiology other than PPH, connective tissue disease, HIV, or repaired ASD, VSD, or
PDA
Age minimum:
12 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Ayerza Syndrome
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Pulmonary Hypertension
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Intervention(s)
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Drug: Iloprost or placebo
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Secondary ID(s)
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Pulmonary Artery
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Cotherix
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STEP STUDY
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Pulmonary Hypertension
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STEP
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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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