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.
This is a dose finding trial. Totally 120 mild-moderate essential hypertension patients will be enrolled. All the patients will be randomized (1:1:1:1) into four groups (SPH3127 50mg, SPH3127 100mg, SPH3127 200mg and placebo). The trial has three phases: the screening phase, the leading phase and the treating phase. The primary endpoints are the changes of DBP and SBP compared to the baseline after 8 weeks of treatment. All the adverse events are required to be collected for safety analyzing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Oral SPH3127 tablet, a kind of renion inhibitor, 50 mg, once daily for 8 weeks.
Oral SPH3127 tablet, a kind of renion inhibitor, 100 mg, once daily for 8 weeks.
Oral SPH3127 tablet, a kind of renion inhibitor, 200 mg, once daily for 8 weeks.
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Beijing Hospital
Beijing, China
The Second Xiangya Hospital of Central South University
Changsha, China
Changes From Baseline in Seated Systolic Blood Pressure (SBP) and Seated Diastolic Blood Pressure (DBP) After 8 Weeks of Treatment.
To compare the changes of SBP and DBP after 8 weeks of treatment between each group.
Time frame: Baseline to 54-58 days
Changes from Baseline in Seated SBP and DBP after 2, 4 and 6 Weeks of Treatment.
To compare the changes of seated SBP and DBP after 2, 4 and 6 weeks of treatment between each group.
Time frame: Baseline to 14±2, 28±2 and 42±2 days
Changes from Baseline in 24-hour Ambulatory Blood Pressure after 8 Weeks of Treatment.
To compare the change from baseline in 24-hour ambulatory blood pressure in each group after 8 weeks of treatment.
Time frame: Baseline to 54-58 days
Effectiveness Rate after 4 and 8 Weeks of Treatment.
To compare the rates that SBP decreased more than 20 mmHg or DBP decreased more than 10 mmHg between each group after 4 and 8 weeks of treatment.
Time frame: Baseline to 28±2 and 56±2 days
Hypertension Controlled Rates after 4 and 8 Weeks of Treatment.
To compare the rates that seated SBP \< 140 mmHg and DBP \< 90 mmHg between each group after 4 and 8 weeks of treatment.
Time frame: Baseline to 28±2 and 56±2 days
Changes from Baseline in Plasma Renin Activity (PRA) Following 2, 4, 6 and 8 Weeks of Treatment.
To compare the changes of plasma renin activity (PRA) in each group after 2, 4, 6 and 8 weeks of treatment.
Time frame: Baseline to 14±2, 28±2,42±2 and 56±2 days
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Oral SPH3127 tablet placebo, once daily for 8 weeks.
Xiangya Hospital Central South University
Changsha, China
West China Hospital of Sichuan University
Chengdu, China
Second People's Hospital of Guangdong Province
Guangdong, China
Inner Mongolia Medical University Affiliated Hospital
Hohhot, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Xuzhou Central Hospital
Xuzhou, China