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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 October 2017 |
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Main ID: |
NCT00741819 |
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Date of registration:
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23/08/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects
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Scientific title:
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An Open Label, Multi-center Study Evaluating the Safety of Long-term Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis® (Iloprost) in Subjects With Pulmonary Arterial Hypertension. |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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73 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00741819 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Between 18 and 75 years of age
- PAH diagnosis defined by following WHO Group I categories: idiopathic/familial,
associated with unrepaired or repaired congenital systemic-to-pulmonary shunts
(repaired >/= 5 years), associated with collagen vascular disease, associated with
HIV, associated with appetite suppressant/toxin use
- Baseline six-minute walk distance (6MWD) >/= 250 meters
- Currently receiving Ventavis and be stable at current dose for 30 days prior to
Baseline
- If currently receiving other approved background therapy (i.e. endothelin receptor
antagonist or phosphodiesterase-5-inhibitor or both) must be on stable dose for 30
days prior to Baseline
- Previous testing (e.g. right heart catheterization, echocardiography) consistent with
diagnosis of PAH
Exclusion Criteria:
- Nursing or pregnant
- Has acute concomitant disease (e.g. portal hypertension, chronic thromboembolic
disease, pulmonary veno-occlusive disease, etc) other than those accepted as part of
the inclusion criteria or has had atrial septostomy
- History of uncontrolled sleep apnea, left-sided heart disease, or parenchymal lung
disease
- Use of investigational drug within 30 days of Baseline
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Inhaled treprostinil
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Primary Outcome(s)
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Number of Adverse Events
[Time Frame: up to 24 months]
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Secondary Outcome(s)
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Treatment Satisfaction Questionnaire of Medication (TSQM)
[Time Frame: Baseline and 12 weeks]
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Six-minute Walk Distance (6MWD)
[Time Frame: Baseline and 12 weeks]
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Drug Administration Activities Questionnaire
[Time Frame: Baseline and 12 weeks]
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N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP)
[Time Frame: Baseline and Week 12]
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Patient Impression of Change
[Time Frame: Baseline and 12 weeks]
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World Health Organization (WHO) Functional Class
[Time Frame: Baseline and 12 Weeks]
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Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
[Time Frame: Baseline and 12 weeks]
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Secondary ID(s)
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RIN-PH-401
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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