The primary aim of the study is to assess the antihypertensive efficacy of SPH3127 in patients with mild to moderate essential hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
957
Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12
Time frame: Measure at week 12 of treatment.
Changes from baseline in mean sitting diastolic blood pressure (msDBP) at week 2, 4, 6, 8 and 10
Time frame: Measured at week 2, 4, 6, 8 and 10 of treatment.
Changes from baseline in mean sitting diastolic blood pressure (msSBP) at week 2, 4, 6, 8, 10 and 12.
Time frame: Measured at week 2, 4, 6, 8, 10, and 12 of treatment.
Total effective rate at week 2, 4, 6, 8, 10 and 12
Time frame: Measured at week 2, 4, 6, 8, 10, and 12 of treatment.
Rate of reaching target blood pressure at week 2, 4, 6, 8, 10 and 12
Time frame: Measured at week 2, 4, 6, 8, 10, and 12 of treatment.
Number of subjects with adverse event.
Time frame: 12 weeks.
Plasma concentration of SPH3127.
Time frame: 12 weeks.
Relationship between SPH3127 exposure and renin inhibition level/efficacy/adverse events
Time frame: 12 weeks.
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1 valsartan capsule
2 tablets
1 valsartan capsule
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