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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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1 March 2021 |
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Main ID: |
NCT00879879 |
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Date of registration:
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10/04/2009 |
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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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Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis
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Scientific title:
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Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00879879 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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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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Marisa Couluris, DO |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of South Florida |
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Key inclusion & exclusion criteria
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INCLUSION CRITERIA:
- Age > 21 years
- Diagnosis of idiopathic pulmonary fibrosis
- Patients taking Coumadin and/or N-acetylcysteine may participate in the study
- Baseline forced vital capacity (FVC) must be greater than or equal to 50%
- Baseline 6 minute walk test distance walked must be greater than or equal to 200
meters not requiring greater than 6 lpm of oxygen
EXCLUSION CRITERIA:
- Pregnant, intending to become pregnant or breastfeeding
- Current or previous smoker of cigarettes or marijuana that recently quit within the
last 6 months prior to enrollment
- Allergy or allergic reaction to Losartan or any other angiotensin II receptor blocker
- Taking losartan or any other angiotensin II receptor blocker
- Baseline systolic blood pressure < 100 mmHg
- Currently taking or has taken immunosuppressant agents within the last month such as
azathioprine, cyclophosphamide, colchicine and/or prednisone
- History of lung transplant
- History of kidney failure or liver disease
- Inability to attend clinic visits
Age minimum:
21 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Precancerous Condition
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Intervention(s)
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Drug: losartan
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Primary Outcome(s)
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Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year
[Time Frame: 1 year]
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Secondary Outcome(s)
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Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year
[Time Frame: 1 year]
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Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year
[Time Frame: 1 year]
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Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year
[Time Frame: 1 year]
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Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year
[Time Frame: 1 year]
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Secondary ID(s)
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5U10CA081920
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SCUSF 0108 Pilot
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SCUSF-PILOT-0108
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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