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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05359068

Enrollment

957

Registered

2022-05-03

Start date

2021-06-10

Completion date

2023-12-26

Last updated

2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Brief summary

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

Interventions

DRUGSPH3127 tablet

1 tablet

DRUGValsartan

1 valsartan capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.
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.
Relationship between SPH3127 exposure and renin inhibition level/efficacy/adverse events	12 weeks.
Number of subjects with adverse event.	12 weeks.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 22, 2026