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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: |
NCT01557647 |
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Date of registration:
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14/03/2012 |
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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 and Efficacy of Inhaled Treprostinil in Patients With PAH
INTREPID |
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Scientific title:
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Inhaled Treprostinil for the Treatment of Pulmonary Arterial Hypertension: A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil. |
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Date of first enrolment:
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June 2012 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT01557647 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Key inclusion & exclusion criteria
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Eligible subjects must:
- Be between 18 and 75 years of age at Screening (as defined by date of informed
consent is signed),
- Have a diagnosis of idiopathic or heritable PAH, PAH associated with connective
tissue disease (CTD), PAH associated with repaired congenital systemic-to-pulmonary
shunts (at least 1 year since repair) or human immunodeficiency virus (HIV)
infection, or PAH associated with appetite suppressant or toxin use.
- Be treatment naïve, or receiving background PAH therapies (e.g., phosphodiesterase
type-5 inhibitor (PDE-5i)and / or endothelin receptor antagonist (ERA)) for less than
1 year prior to Screening.
- Have a 6MWD at Baseline (as measured by the mean value of two 6MWT separated by at
least 24 hours, but no more than 14 days) that is between 150 - 500 meters,
inclusive.
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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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Placebo
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Drug: Inhaled treprostinil
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Primary Outcome(s)
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Six-minute walk test
[Time Frame: 6 months]
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Secondary Outcome(s)
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Time to clinical worsening
[Time Frame: 1 day to 2.5 years.]
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Secondary ID(s)
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RIN-PH-302
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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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