Anagre Cap. in Patients With High-Risk Essential Thrombocythemia
NCT ID: NCT03232177
Last Updated: 2021-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2017-06-05
2020-12-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Anagre Cap.
twice a day
Anagre Cap.
from 0.5mg twice a day to maximally increase total10mg in 8 weeks and maintain maximal tolerable dose to 104 weeks
Interventions
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Anagre Cap.
from 0.5mg twice a day to maximally increase total10mg in 8 weeks and maintain maximal tolerable dose to 104 weeks
Eligibility Criteria
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Inclusion Criteria
* Any of the following as high-risk patient
* Over 60 years old
* \>100 X 10\^4/ul of platelet count
* increased more than 300K of platelet count in 3 months
* Hypertension, diabetes, past history of thromboembolic bleeding
Exclusion Criteria
* Any of the following cardiac abnormalities;
* Complete left bundle branch block on ECG
* Patients using a pacemaker
* Patients with a family history of congenital QT prolongation syndrome or known QT prolongation syndrome
* Currently, there is no clinically uncontrolled ventricular or atrial tachycardia
* Clinically significant bradycardia (\<less than 50 per minute)
* History of clinically proven myocardial infarction and unstable angina within 3 months
* Pregnant women, nursing mothers
19 Years
ALL
No
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Locations
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National Health Insurance Service Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
The Catholic University of Korea. ST. Vincents Hospital
Suwon, Gyeonggi-do, South Korea
Hallym UNIV. Medical Center
Anyang, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Kyungpook national university hospital
Daegu, , South Korea
Dongguk University Medical Center
Goyang, , South Korea
Cheonnam National University Hwasun Hospital
Hwasun, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
Jeju National University Hospital
Jeju City, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Ewha Wonans University Mokdong Hospital
Seoul, , South Korea
Hallym UNIV. Medical Center
Seoul, , South Korea
Inje University Sanggye Paik Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
SMG - SNU Boramae Medical Center
Seoul, , South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, , South Korea
Veterans Health Service medical Center
Seoul, , South Korea
Yonsei University Health System, SEVERANCE HOSPITAL
Seoul, , South Korea
Countries
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Other Identifiers
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YMC018
Identifier Type: -
Identifier Source: org_study_id
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