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

Shanghai Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: SPH3127 tablet; Drug: Valsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT05359068

SPH3127-301

Details and patient eligibility

About

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

Enrollment: 957 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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957 participants in 7 patient groups

Stage 1 Arm A

Experimental group

Description:

1 SPH3127 tablet，3 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.

Treatment:

Drug: SPH3127 tablet

Drug: SPH3127 tablet

Drug: SPH3127 tablet

Drug: SPH3127 tablet

Stage 1 Arm B

Experimental group

Description:

2 SPH3127 tablets，2 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.

Treatment:

Drug: SPH3127 tablet

Drug: SPH3127 tablet

Drug: SPH3127 tablet

Drug: SPH3127 tablet

Stage 1 Arm C

Experimental group

Description:

4 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.

Treatment:

Drug: SPH3127 tablet

Drug: SPH3127 tablet

Drug: SPH3127 tablet

Drug: SPH3127 tablet

Stage 1 Arm D

Experimental group

Description:

4 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.

Treatment:

Drug: Valsartan

Drug: Valsartan

Stage 2 Arm A

Experimental group

Description:

2 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.

Treatment:

Drug: SPH3127 tablet

Drug: SPH3127 tablet

Drug: SPH3127 tablet

Drug: SPH3127 tablet

Stage 2 Arm B

Experimental group

Description:

2 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.

Treatment:

Drug: Valsartan

Drug: Valsartan

Stage 3

Experimental group

Description:

2 SPH3127 tablets, once daily for 40 weeks.

Treatment:

Drug: SPH3127 tablet

Drug: SPH3127 tablet

Drug: SPH3127 tablet

Drug: SPH3127 tablet