A Randomized Trial of Angiotensin Receptor bLocker,Fimasartan, in Aortic Stenosis (ALFA Trial)

PHASE4UnknownINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

May 31, 2013

Study Completion Date

December 31, 2014

Conditions
Critical Stenosis of Aortic Valve
Interventions
DRUG

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."

DRUG

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.

Trial Locations (7)

501-757

RECRUITING

Chonnam University Hospital, Gwangju

463-707

RECRUITING

Seoul National University Bundang Hospital, Seongnam-si

110-744

RECRUITING

Seoul National University Hospital, Seoul

135-710

RECRUITING

Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul

136-705

RECRUITING

Korea University Anam Hospital, Seoul

RECRUITING

Korea University Guro Hospital, Seoul

705-717

RECRUITING

Yonsei University Hospital, Seoul

Sponsors
All Listed Sponsors
collaborator

Boryung Pharmaceutical Co., Ltd

INDUSTRY

collaborator

Seoul National University Bundang Hospital

OTHER

collaborator

Severance Hospital

OTHER

collaborator

Korea University Anam Hospital

OTHER

collaborator

Korea University Guro Hospital

OTHER

collaborator

Chonnam National University Hospital

OTHER

collaborator

Samsung Medical Center

OTHER

lead

Seoul National University Hospital

OTHER