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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: |
NCT00004654 |
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Date of registration:
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24/02/2000 |
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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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Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia
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Scientific title:
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Date of first enrolment:
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January 1996 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00004654 |
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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: Crossover Assignment, Primary Purpose: Treatment
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Phase:
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Phase 3
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Contacts
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Name:
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Joshua R. Korzenik |
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Address:
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Telephone:
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Email:
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Affiliation:
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Yale University |
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Key inclusion & exclusion criteria
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- Hereditary hemorrhagic telangiectasia (HHT) with 2 of the following:
- First-degree relative with HHT
- History of recurrent epistaxis or gastrointestinal bleeding
- Three or more skin telangiectasia
- Migraine headache meeting International Headache Society criteria 3 or more times a
month for more than 1 year
- No pattern of daily headaches
- No severe head trauma
- No onset of headaches after 50 years of age
- At least 1 month since migraine prophylaxis
- At least 1 month since any of the following medications: Beta blockers; Calcium
channel blockers; Divalproex sodium; Tricyclic antidepressants; Selective serotonin
re-uptake inhibitors
- Concurrent regular treatment for migraine and gastrointestinal hemorrhage allowed
- Creatinine no greater than 2.5 g/dL
- No allergy to soy
- No pregnant women
- No women with intent to become pregnant
Age minimum:
15 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hereditary Hemorrhagic Telangiectasia
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Intervention(s)
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Drug: soy protein isolate
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Secondary ID(s)
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199/11799
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YALESM-8191
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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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