Trial Outcomes & Findings for A Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan (BR-A-657•K) During 24 Hours in Patients With Mild to Moderate Essential Hypertension (NCT NCT00922441)

NCT ID: NCT00922441

Last Updated: 2018-03-15

Results Overview

24hr Mean change of DBP on Week 8, from Baseline

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 92 participants
• Primary outcome timeframe: baseline and 8 Weeks
• Results posted on: 2018-03-15

Participant Flow

Participant milestones

Measure	Fimasartan 1 Fimasartan 60 mg group Fimasartan 60 mg daily, po	Fimasartan 2 Fimasartan 120 mg group Fimasartan 120 mg daily, po	Valsartan: Control Reference (Valsartan 80 mg) group Valsartan 80 mg daily, po
Overall Study STARTED	30	30	32
Overall Study COMPLETED	30	30	29
Overall Study NOT COMPLETED	0	0	3

Reasons for withdrawal

Measure	Fimasartan 1 Fimasartan 60 mg group Fimasartan 60 mg daily, po	Fimasartan 2 Fimasartan 120 mg group Fimasartan 120 mg daily, po	Valsartan: Control Reference (Valsartan 80 mg) group Valsartan 80 mg daily, po
Overall Study Protocol Violation	0	0	2
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

A Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan (BR-A-657•K) During 24 Hours in Patients With Mild to Moderate Essential Hypertension

Baseline characteristics by cohort

Measure	Fimasartan 1 n=30 Participants Fimasartan 60 mg group Fimasartan 60 mg daily, po	Fimasartan 2 n=30 Participants Fimasartan 120 mg group Fimasartan 120 mg daily, po	Valsartan: Control n=32 Participants Reference (Valsartan 80 mg) group Valsartan 80 mg daily, po	Total n=92 Participants Total of all reporting groups
Age, Continuous	52.07 years STANDARD_DEVIATION 8.36 • n=5 Participants	54.07 years STANDARD_DEVIATION 8.79 • n=7 Participants	56.00 years STANDARD_DEVIATION 7.15 • n=5 Participants	54.09 years STANDARD_DEVIATION 8.18 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants	36 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	16 Participants n=7 Participants	19 Participants n=5 Participants	56 Participants n=4 Participants

PRIMARY outcome

Timeframe: baseline and 8 Weeks

24hr Mean change of DBP on Week 8, from Baseline

Outcome measures

Measure	Fimasartan 1-ITT n=30 Participants Fimasartan 60 mg group Fimasartan 60 mg daily, po	Fimasartan 2-ITT n=30 Participants Fimasartan 120 mg group Fimasartan 120 mg daily, po	Valsartan: Control-ITT n=29 Participants Reference (Valsartan 80 mg) group Valsartan 80 mg daily, po
Mean Change of Diastolic Blood Pressure	-10.15 mmHg Standard Deviation 5.94	-7.19 mmHg Standard Deviation 9.51	-6.70 mmHg Standard Deviation 6.61

Adverse Events

Fimasartan 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Fimasartan 2

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Valsartan: Control

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fimasartan 1 n=30 participants at risk Fimasartan 60 mg group Fimasartan 60 mg daily, po	Fimasartan 2 n=30 participants at risk Fimasartan 120 mg group Fimasartan 120 mg daily, po	Valsartan: Control n=32 participants at risk Reference (Valsartan 80 mg) group Valsartan 80 mg daily, po
Nervous system disorders Dizziness	6.7% 2/30 • Number of events 2	0.00% 0/30	0.00% 0/32
Nervous system disorders Headache	6.7% 2/30 • Number of events 2	3.3% 1/30 • Number of events 1	3.1% 1/32 • Number of events 1
Infections and infestations Nasopharyngitis	0.00% 0/30	6.7% 2/30 • Number of events 2	3.1% 1/32 • Number of events 1
Investigations ALT Increased	0.00% 0/30	6.7% 2/30 • Number of events 2	0.00% 0/32

Additional Information

Manager of Clinical Research

Boryung Pharmaceutical

Phone: +82-2-708-8069

Email: rainbowleo@boryung.co.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place