This trial is active, not recruiting.

Conditions blood pressure, ischemic stroke
Treatments fimasartan, valsartan, atenolol
Phase phase 4
Sponsor Ajou University School of Medicine
Collaborator Boryung Pharmaceutical Co., Ltd
Start date May 2012
End date May 2015
Trial size 105 participants
Trial identifier NCT02403349, AJIRB-MED-CT4-12-049-HJM


Confirm central blood pressure reduction effect of Fimasartan, Valsartan and Atenolol and compare correlation with the measured peripheral (central blood pressure, pulse wave velocity, and flow-mediated dilation) and cerebral blood flow factors (transcranial doppler findings, cerebral blood flow volume) in acute ischemic stroke patients with hypertension.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
fimasartan potassium 60mg, 1 tablet by mouth, every day Angiotensin ll receptor blocker
fimasartan kanarb
(Active Comparator)
valsartan 80mg, 1 tablet by mouth, every day angiotensin II receptor antagonists
valsartan Diovan
(Active Comparator)
atenolol 50mg, 1 tablet by mouth, every day beta-blocker
atenolol tenormin

Primary Outcomes

Central Blood pressure control
time frame: 12 weeks

Secondary Outcomes

Blood pressure at the brachial artery
time frame: 12 weeks
Brachial-ankle pulse wave velocity (ba-PWV)
time frame: 12 weeks
Flow-mediated dilation (FMD)
time frame: 12 weeks
Pulsatile index (PI)
time frame: 12 weeks
Cerebral blood flow (CBF) volume
time frame: 12 weeks
Adverse Events
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 30 years old.

Inclusion Criteria: - Age ≥ 30 years old - Acute ischemic stroke patient who has corresponding DWI(diffusion- weighted imaging) lesion correlated with symptom - after 7days, but within 28days from stroke onset - Diagnosed with Hypertension - hypertensive patients who taking anti-hypertensive drugs or SBP≥140mmHg - Informed consent Exclusion Criteria: - Patients with hemorrhagic Stroke - Patients with severe Stroke - over NIHss(National Institutes of Health stroke scale) 16 - Uncontrolled hypertension (SBP ≥200mmHg) - Patients with history of allergic reaction to any angiotensin II antagonist - Liver disease(more than double to normal level, SGOT(serum glutamic-oxaloacetic transaminase ), SGPT(serum glutamic-pyruvic transaminase ), total bilirubin) - Renal disease(serum creatinine ≥2.0mg/dl) - Anemia(Hb < 8mg/dl) - Thrombocytopenia( < 10^3/ml) - Patients with secondary hypertension - Childbearing and breast-feeding women - Otherwise inappropriate patients depending on the investigator's decision

Additional Information

Official title Comparison of Peripheral and Cerebral Arterial Flow in Acute Ischemic Stroke: Fimasartan vs. Valsartan vs. Atenolol
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Ajou University School of Medicine.