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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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16 December 2017 |
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Main ID: |
NCT00359736 |
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Date of registration:
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31/07/2006 |
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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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Sildenafil Study to Treat Idiopathic Pulmonary Fibrosis
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Scientific title:
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Vasodilator Therapy and Exercise Tolerance in IPF Patients |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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29 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00359736 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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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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Robert M Jackson, 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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VA Medical Center, Miami |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of IPF
- 40-85 years of age
- 6-minute walk distance 150-500 m
- FVC 40-90% predicted
- DLCO 30-90% predicted
Exclusion Criteria:
- Severe pulmonary hypertension
- Severe heart failure
- FEV1/FVC < 0.7
Age minimum:
40 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alveolitis, Fibrosing
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Fibrosis, Pulmonary
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Hypertension, Pulmonary
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Intervention(s)
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Drug: sildenafil
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Primary Outcome(s)
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Change in 6-minute Walk Test
[Time Frame: 0 - 6 months]
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Secondary Outcome(s)
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Dyspnea Score (Borg Scale)
[Time Frame: 0 - 6 months]
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Secondary ID(s)
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CLIN-009-05F
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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