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

Phase 3

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: SPH3127 tablet; Drug: Valsartan

• Registration Number: NCT05359068
• Lead Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-10
• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-05-03
• Status Verified: 2023-06
• Primary Completion: 2023-12-26
• Study Completion: 2023-12-26
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 957

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stage 1 Arm A	SPH3127 tablet	1 SPH3127 tablet，3 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
Stage 1 Arm B	SPH3127 tablet	2 SPH3127 tablets，2 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
Stage 1 Arm C	SPH3127 tablet	4 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
Stage 2 Arm A	SPH3127 tablet	2 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
Stage 3	SPH3127 tablet	2 SPH3127 tablets, once daily for 40 weeks.
Stage 1 Arm D	Valsartan	4 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.
Stage 2 Arm B	Valsartan	2 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12	Measure at week 12 of treatment.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (40)

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Pinggu Hospital; 🇨🇳 Beijing, Beijing, China

Affiliated Hospital of Chongqing Three Gorges Medical College; 🇨🇳 Chongqing, Chongqing, China

Lanzhou University Second Hospital; 🇨🇳 Lanzhou, Gansu, China

Guangdong Second Provincial General Hospital; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Liuzhou people's Hospital; 🇨🇳 Liuzhou, Guangxi, China

Hainan Third People's Hospital; 🇨🇳 Sanya, Hainan, China

Cangzhou Central Hospital; 🇨🇳 Cangzhou, Hebei, China

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