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

Study Overview
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Brief Summary
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The primary aim of the study is to assess the antihypertensive efficacy of SPH3127 in patients with mild to moderate essential hypertension.

Official Title
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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

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: SPH3127 tablet
* Drug: SPH3127 tablet
* Drug: SPH3127 tablet
* Drug: Valsartan
* Drug: SPH3127 tablet
* Drug: Valsartan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage 1 Arm A<br>1 SPH3127 tablet，3 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks. | Drug: SPH3127 tablet<br>* 1 tablet<br>|
| Experimental: Stage 1 Arm B<br>2 SPH3127 tablets，2 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks. | Drug: SPH3127 tablet<br>* 2 tablets<br>|
| Experimental: Stage 1 Arm C<br>4 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks. | Drug: SPH3127 tablet<br>* 4 tablets<br>|
| Experimental: Stage 1 Arm D<br>4 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks. | Drug: Valsartan<br>* 1 valsartan capsule<br>|
| Experimental: Stage 2 Arm A<br>2 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks. | Drug: SPH3127 tablet<br>* 2 tablets<br>|
| Experimental: Stage 2 Arm B<br>2 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks. | Drug: Valsartan<br>* 1 valsartan capsule<br>|
| Experimental: Stage 3<br>2 SPH3127 tablets, once daily for 40 weeks. | Drug: SPH3127 tablet<br>* 2 tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12 |  | Measure at week 12 of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |