Safety and Efficacy of SPH3127 on Treating Mild-moderate Essential Hypertension Patients (NCT03756103) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of SPH3127 on Treating Mild-moderate Essential Hypertension Patients
China120 participantsStarted 2019-01-11
Plain-language summary
SPH3127 tablet is a of renin inhibitor. It is expected to be a new drug for essential hypertension. This is a phase IIa trial which designed to evaluate its efficacy and safety on treating mild-moderate essential hypertension patients.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female who is 18 - 65 years old.
✓. Subject who is meeting the diagnostic criteria of mild-moderate essential hypertension：mean seated Systolic Blood Pressure (SBP) (2\~3 times average) ≥ 140 mmHg and ≤ 179 mmHg and mean seated Diastolic Blood Pressure (DBP) (2\~3 times average)≥ 90 and ≤ 109 mmHg.
✓. Laboratory testing should:
Exclusion criteria
✕. Subject who is diagnosed as a secondary hypertension.
✕. Subject who is suspected to be malignant hypertension, hypertensive emergency, hypertensive urgencies patients.
✕. Subject who is at risk when the current anti-hypertensive therapy discontinued.
✕. Subject who is suffered by chronic congestive heart failure (NYHA III and IV) or myocardial infarction within 6 months. Subject has had or is currently suffered by serious heart disease, such as unstable angina, cardiogenic shock, arrhythmia to that needs treatment, heart valve disease, hypertrophic cardiomyopathy, rheumatic heart disease, etc.
✕. Subject who is suffered by severe cerebrovascular disease or shock within 6 months, such as hypertensive encephalopathy, cerebrovascular injury, cerebral hemorrhage, transient ischemic attack etc.
✕. Subject who is suffered by severe or malignant retinopathy. The severe lesions is defined as retinal hemorrhage, micro aneurysm, cotton wool patches, hard exudate or a combination of these symptoms. The malignant lesions defined as the combination of severe retinopathy and optic disc edema.
What they're measuring
1
Changes From Baseline in Seated Systolic Blood Pressure (SBP) and Seated Diastolic Blood Pressure (DBP) After 8 Weeks of Treatment.