A Multi-center, Randomized, Double-blind, Double-Dummy, Positive Parallel Controlled Study to Evaluate the Efficacy and Safety in Treatment of Mild-moderate Essential Hypertension
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 957
- Locations
- 40
- Primary Endpoint
- Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12
Study Overview
Brief Summary
The primary aim of the study is to assess the antihypertensive efficacy of SPH3127 in patients with mild to moderate essential hypertension.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female of age ≥18 years;
- •Diagnosed with mild-moderate essential hypertension;
- •Participant has understood the study-required procedures, voluntarily signed informed consent.
Exclusion Criteria
- •Diagnosed with secondary hypertension, suspected grade 3 hypertension, acute hypertension, or at risk when current antihypertensive therapy discontinued;
- •Suffered by severe heart disease within 6 months;
- •Suffered by severe cerebrovascular disease within 6 months;
- •Suffered by severe or malignant retinopathy;
- •Out of controlled diabetes;
- •History of malignant tumor;
- •History of mental disorder;
- •Subject is planning or in use of other antihypertensive drugs or other drugs may affect blood pressure during the trial;
- •Alcohol or drug abuse;
- •Pregnant, lactating women or subject is planning to pregnant within 6 months after the trial;
- •Assessed by the investigators as unsuitable for participating in the study.
Arms & Interventions
Stage 1 Arm A
1 SPH3127 tablet，3 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
Intervention: SPH3127 tablet (Drug)
Stage 1 Arm B
2 SPH3127 tablets，2 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
Intervention: SPH3127 tablet (Drug)
Stage 1 Arm C
4 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
Intervention: SPH3127 tablet (Drug)
Stage 1 Arm D
4 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.
Intervention: Valsartan (Drug)
Stage 2 Arm A
2 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
Intervention: SPH3127 tablet (Drug)
Stage 2 Arm B
2 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.
Intervention: Valsartan (Drug)
Stage 3
2 SPH3127 tablets, once daily for 40 weeks.
Intervention: SPH3127 tablet (Drug)
Outcomes
Primary Outcomes
Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12
Time Frame: Measure at week 12 of treatment.
Secondary Outcomes
- Changes from baseline in mean sitting diastolic blood pressure (msSBP) at week 2, 4, 6, 8, 10 and 12.(Measured at week 2, 4, 6, 8, 10, and 12 of treatment.)
- Changes from baseline in mean sitting diastolic blood pressure (msDBP) at week 2, 4, 6, 8 and 10(Measured at week 2, 4, 6, 8 and 10 of treatment.)
- Plasma concentration of SPH3127.(12 weeks.)
- Total effective rate at week 2, 4, 6, 8, 10 and 12(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(Measured at week 2, 4, 6, 8, 10, and 12 of treatment.)
- Number of subjects with adverse event.(12 weeks.)
- Relationship between SPH3127 exposure and renin inhibition level/efficacy/adverse events(12 weeks.)