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

SPH3127-301

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

2021-06-10

2023-12-26

2023-12-26

Completed

Early phase I

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 957, 'type': 'ACTUAL'}}

2024-05-07