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NCT03231293 Clinical Trial

Fimasartan Blood Pressure Lowering After Acute Stroke

Hypertension Clinical Trial

— FABULOUS  

Official title:
A Multicenter Longitudinal Observational Study to Assess the Effectiveness of Fimasartan-based Antihypertensive Treatment and Prognosis in Post-Acute Phase of Ischemic Stroke or Transient Ischemic Attack

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03231293
Other study ID # BR-FMS-OS-401
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 28, 2016
Est. completion date April 5, 2019

Study information
Verified date November 2019
Source Boryung Pharmaceutical Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the effectiveness of fimasartan-based antihypertensive treatment and prognosis in post-acute phase of ischemic stroke or transient ischemic attack patients. All participants will receive fimasartan, and the investigators will follow them up for 6 months.

Recruitment information / eligibility
Status Completed
Enrollment 1035
Est. completion date April 5, 2019
Est. primary completion date November 2, 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Ischemic stroke or transient ischemic attack occurs after 7 days to 3 months.

- Mean blood pressure measured 3 times at the first visit (Visit 1) should be over 140 mmHg for systolic blood pressure or 90 mmHg for diastolic blood pressure

- Suitable for administration of fimasartan

- The life expectancy should be over 6 months.

Exclusion Criteria:

- Patients already treated with antihypertensive medications

- Hemorrhagic stroke patients

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Korea University Ansan Hospital Ansan
Korea, Republic of Hallym University Medical Center Anyang
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Inje University Busan Paik Hospital Busan
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Daejeon Eulji Medical Center Daejeon
Korea, Republic of Inje University Ilsan Paik Hospital Goyang
Korea, Republic of Myongji Hospital Goyang
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of Chosun University Hospital Gwangju
Korea, Republic of Inha University Hospital Incheon
Korea, Republic of Jeju National University Hospital Jeju
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Ewha Womans University Medical Center Seoul
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Inje University Sanggye Paik Hospital Seoul
Korea, Republic of Kyunghee University Medical Center Seoul
Korea, Republic of Nowon Eulji Medical Center, Eulji University Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Boramae Medical Center Seoul
Korea, Republic of Seoul St. Mary's Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of Soonchunhyang University Hospital Seoul
Korea, Republic of Ulsan University Hospital Ulsan

Sponsors (1)
Lead Sponsor Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary BP Blood pressure control rate(<140/90 mmHg) 24 weeks
Secondary BP Blood pressure control rate(<140/90 mmHg) 4, 12 weeks
Secondary BP Blood pressure changes 4, 12, 24 weeks
Secondary mRS mRS changes 4, 12, 24 weeks
Secondary Fimasartan-based treatment Fimasartan-based treatment modalities 24 weeks
Secondary Fimasartan starting point Fimasartan starting point after stroke 24 weeks
Secondary Stroke recurrence Rate of stroke recurrence 24 weeks
Secondary Cardiovascular events Incidence of cardiovascular events 24 weeks
Secondary Mortality rates from cardiovascular disease Mortality rates from cardiovascular disease 24 weeks
Secondary Mortality rates of any cause Mortality rates of any cause 24 weeks
Secondary Adverse events Adverse events related to antihypertensive treatments 24 weeks
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