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| Name | Class |
|---|---|
| R&G Pharma Studies Co.,Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPH3127 tablet Dose 1 | Experimental | Low-dose group |
|
| SPH3127 tablet Dose 2 | Experimental | Mid-dose group |
|
| SPH3127 tablet Dose 3 | Experimental | High-dose group |
|
| SPH3127 tablet Placebo | Placebo Comparator | Placebo Control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH3127 tablet Dose 1 | Drug | Oral SPH3127 tablet, a kind of renion inhibitor, 50 mg, once daily for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 54-58 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 14±2, 28±2 and 42±2 days |
| Changes from Baseline in 24-hour Ambulatory Blood Pressure after 8 Weeks of Treatment. |
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Inclusion Criteria:
(1) GFR* ≥ 60mL/min (2) AST or ALT is less than 2 times upper limit of normal (3) Hemoglobin ≥ 90g/L (4) Serum potassium ≥ 3.5mmol/L and ≤ 5.5mmol/L *the conversion formulas for GFR* Male:GFR=186×(Scr)^-1.154×(age)^-0.203; Female:GFR=186×(Scr)^-1.154×(age)^-0.203×0.742; Serum creatinine(Scr) unit:µmol/L.
Exclusion Criteria:
Chinese
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| Name | Affiliation | Role |
|---|---|---|
| Changsheng Ma, Doctor | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | China | ||||
| Beijing Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38632457 | Derived | Wang F, Liu L, Ruan H, Chen X, Zhang Y, Yu Z, Li Y, Guan Y, Wang J, Huang K, Yu S, Cao Y, Ding C, Chang L, Huang Y, Chen X, Lv Q, Ma C. A randomized, double-blind, placebo-controlled, phase IIa, clinical study on investigating the efficacy and safety of SPH3127 tablet in patients with essential hypertension. Hypertens Res. 2024 Jul;47(7):1925-1933. doi: 10.1038/s41440-024-01657-z. Epub 2024 Apr 17. |
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| SPH3127 tablet Dose 2 | Drug | Oral SPH3127 tablet, a kind of renion inhibitor, 100 mg, once daily for 8 weeks. |
|
|
| SPH3127 tablet Dose 3 | Drug | Oral SPH3127 tablet, a kind of renion inhibitor, 200 mg, once daily for 8 weeks. |
|
|
| SPH3127 tablet Placebo | Drug | Oral SPH3127 tablet placebo, once daily for 8 weeks. |
|
|
To compare the change from baseline in 24-hour ambulatory blood pressure in each group after 8 weeks of treatment. |
| 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. | 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. | 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. | Baseline to 14±2, 28±2,42±2 and 56±2 days |
| Beijing |
| China |
| The Second Xiangya Hospital of Central South University | Changsha | China |
| 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 |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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