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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: |
NCT00109681 |
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Date of registration:
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02/05/2005 |
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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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Inhaled Iloprost in Adults With Abnormal Pulmonary Pressure and Associated With Idiopathic Pulmonary Fibrosis
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Scientific title:
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A Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety and Pilot Efficacy of Iloprost Inhalation Solution in Adults With Abnormal Pulmonary Arterial Pressure and Exercise Limitation Associated With Idiopathic Pulmonary Fibrosis (IPF) |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00109681 |
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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: 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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James Pennington, 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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CoTherix |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of idiopathic pulmonary fibrosis according to American Thoracic Society
criteria
- Diagnosis of elevated pulmonary pressures
- Six minute walk distance between 50-380
- NYHA functional class II - IV
Exclusion Criteria:
- Pulmonary fibrosis related to a systemic disorder
- Significant chronic obstructive pulmonary disease
- History of thromboembolic disease within the previous year
- Awaiting lung transplantation within next 36 weeks
- Active lung infection
- Survival prognosis of less than 1 year
- Significant left-sided heart failure, active coronary artery disease
- Clinically relevant liver disease
- Concurrent medications: epoprostenol, treprostinil, bosentan, PDE-5 inhibitor,
investigational agents
Age minimum:
40 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Fibrosis
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Pulmonary Hypertension
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Intervention(s)
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Drug: Iloprost Inhalation Solution (Ventavis)
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Primary Outcome(s)
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Safety
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Secondary Outcome(s)
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6 minute walk distance
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exercise associated oxygen desaturation
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Secondary ID(s)
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ACTIVE C200-003
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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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