100
Participants
Start Date
April 30, 2012
Primary Completion Date
May 31, 2013
Study Completion Date
December 31, 2014
Fimasartan
"Fimasartan, Initial dose will be started with 30mg per day. At 12 months follow-up after the enrollment, dose titration up to 60 mg per day will be made with target blood pressure of 120/80.~Dose escalization from 30mg/day to 60mg/day will be performed in the case of follow-up systolic blood pressure is over 120. If the follow-up systolic blood pressure is less than 120, initial dose of 30mg/day will be maintained throughout the study duration. If hypotension (BP \< 90/60) is developed, the study medication will be discontinued and the patient will be included safety outcome analysis and intention to treat analysis. Per protocol analysis will be also performed. The dose of placebo will be adjusted identically, according to the blood pressure criteria of fimasartan."
Placebo
Placebo was used in phase 3 clinical trial of fimasartan (NCT00922480, NCT01135212, and NCT01258673). The same placebo, which is manufactures at Boryoung pharmaceutical company, will be used in this trial. After enrollment and randomization, placebo will be administered one capsule once daily in placebo group.
RECRUITING
Chonnam University Hospital, Gwangju
RECRUITING
Seoul National University Bundang Hospital, Seongnam-si
RECRUITING
Seoul National University Hospital, Seoul
RECRUITING
Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul
RECRUITING
Korea University Anam Hospital, Seoul
RECRUITING
Korea University Guro Hospital, Seoul
RECRUITING
Yonsei University Hospital, Seoul
Collaborators (1)
Boryung Pharmaceutical Co., Ltd
INDUSTRY
Seoul National University Bundang Hospital
OTHER
Severance Hospital
OTHER
Korea University Anam Hospital
OTHER
Korea University Guro Hospital
OTHER
Chonnam National University Hospital
OTHER
Samsung Medical Center
OTHER
Seoul National University Hospital
OTHER