This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040\_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of BAYA1040\_Nifedipine 40 mg once daily and other antihypertensives.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Nifedipine (Adalat, BAYA1040) 40mg twice a day (BID)
Unnamed facility
Ebina, Kanagawa, Japan
Unnamed facility
Sagamihara, Kanagawa, Japan
Unnamed facility
Kawaguchi, Saitama, Japan
Unnamed facility
Shinjuku, Tokyo, Japan
Efficacy changes measured by sitting diastolic blood pressure (DBP)
Time frame: Up to 52 weeks
Efficacy changes measured by sitting systolic blood pressure (SBP)
Time frame: Up to 52 weeks
Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
Time frame: Up to 52 weeks
Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
Time frame: Up to 52 weeks
Safety variables
Adverse events, vital signs, electrocardiography (ECG), and laboratory tests were evaluated.
Time frame: Up to 30 days after the last dose of study drug
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