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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: |
NCT00451594 |
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Date of registration:
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22/03/2007 |
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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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High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP
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Scientific title:
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A Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic Purpura |
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Date of first enrolment:
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September 2005 |
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Target sample size:
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157 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00451594 |
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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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Sung Hwa Bae, professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Daegu Catholic Univertity Hospital, ROK |
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Name:
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Jung-Hee Lee, professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Asan Medical Center, ROK |
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Key inclusion & exclusion criteria
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Inclusion Criteria :
- a true thrombocytopenia on blood smear
- adequate megakaryopoiesis on bone marrow examination
- the absence of clinically apparent associated conditions or cause of
thrombocytopenia
- Age over 16 years
- A platelet count of less than 30x109/L
Exclusion criteria :
- previous treatment for ITP.
- other causes of thrombocytopenia such as HIV infection, lymphproliferative disease,
liver disease, or definite SLE.
- Patients with life threatening bleeding and pregnant women should be excluded.
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Idiopathic Thrombocytopenic Purpura
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Intervention(s)
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Drug: Prednisolone
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Drug: Dexamethasone
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Primary Outcome(s)
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response rate and platelet count
[Time Frame: 6 years]
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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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