This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for whom the test drug is tolerable during the 8 week double blind treatment phase of Study 13176.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
BAYA1040 CR 40mg BID
Unnamed facility
Hirosaki, Aomori, Japan
Unnamed facility
Kamagaya, Chiba, Japan
Unnamed facility
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time frame: Week 52
Changes from baseline in diastolic blood pressure (DBP) while sitting
Time frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
Changes from baseline in systolic blood pressure (SBP) while sitting
Time frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
Time frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
Time frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Asahikawa, Hokkaido, Japan
Unnamed facility
Asahikawa, Hokkaido, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
...and 12 more locations