Study to Evaluate the Efficacy and Safety of SPH3127 In Patients With Mild-moderate Essential Hypertension

• SPH3127 tablet (Drug): 1 tablet
• SPH3127 tablet (Drug): 2 tablets
• SPH3127 tablet (Drug): 4 tablets
• Valsartan (Drug): 1 valsartan capsule
• SPH3127 tablet (Drug): 2 tablets
• Valsartan (Drug): 1 valsartan capsule

Primary outcomes

• Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12 [Measure at week 12 of treatment.]

Secondary outcomes

• 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.]
• 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.]
• 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.]
• Plasma concentration of SPH3127. [12 weeks.]
• Relationship between SPH3127 exposure and renin inhibition level/efficacy/adverse events [12 weeks.]

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Male or female of age ≥18 years;
2. Diagnosed with mild-moderate essential hypertension;
3. Participant has understood the study-required procedures, voluntarily signed informed consent.

Exclusion Criteria:

1. Diagnosed with secondary hypertension, suspected grade 3 hypertension, acute hypertension, or at risk when current antihypertensive therapy discontinued;
2. Suffered by severe heart disease within 6 months;
3. Suffered by severe cerebrovascular disease within 6 months;
4. Suffered by severe or malignant retinopathy;
5. Out of controlled diabetes;
6. History of malignant tumor;
7. History of mental disorder;
8. Subject is planning or in use of other antihypertensive drugs or other drugs may affect blood pressure during the trial;
9. Alcohol or drug abuse;
10. Pregnant, lactating women or subject is planning to pregnant within 6 months after the trial;
11. Assessed by the investigators as unsuitable for participating in the study.

• Results publication: Lv Q, Ma C, Wang F, Li L, Xiong G, Li Z, Qu Y, Pang W, Xiao W, Ruan H, Wei L, Liu G, Zhang J, Liu Q, Lin L, Long M, Li H, Yuan H, Liu L, Gao Y, Liu P, Zhang C, Wang Z, Xie J, Wang J, Zhang X, Lu Y, Huang K, Liu M, Chen J, Gao X, Wang D, Ma X, Chen X, Li Y, Zhang Y, Kong X, Chen F, Zhang X, Qi J, Cao Y, Huang Y, Zhang Y, Cui W. Efficacy and Safety of SPH3127 Tablet, a Novel Direct Renin Inhibitor, in Patients with Mild-to-Moderate Essential Hypertension: A Phase III Randomised Trial. Drugs. 2026 Jul;86(7):1121-1132. doi: 10.1007/s40265-026-02315-z. Epub 2026 May 21. PMID 42165988

• Changsheng Ma, Principal investigator, Beijing Anzhen Hospital, Capitcal Medical University