A Phase 2 interventional study of SPH3127 tablet Dose 1 and SPH3127 tablet Dose 2 in Hypertension,Essential, sponsored by Shanghai Pharmaceuticals Holding Co., Ltd. Completed at 10 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-11-15.
Sponsored by Shanghai Pharmaceuticals Holding Co., Ltd · Phase 2, Interventional, and Treatment
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 120 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Shanghai Pharmaceuticals Holding Co., Ltd is the lead sponsor of 35 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
(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:
Low-dose group
Drug: SPH3127 tablet Dose 1
Mid-dose group
Drug: SPH3127 tablet Dose 2
High-dose group
Drug: SPH3127 tablet Dose 3
Placebo Control group
Drug: SPH3127 tablet Placebo
Oral SPH3127 tablet, a kind of renion inhibitor, 50 mg, once daily for 8 weeks.
Also known as: renion inhibitor
Oral SPH3127 tablet, a kind of renion inhibitor, 100 mg, once daily for 8 weeks.
Also known as: renion inhibitor
Oral SPH3127 tablet, a kind of renion inhibitor, 200 mg, once daily for 8 weeks.
Also known as: renion inhibitor
Oral SPH3127 tablet placebo, once daily for 8 weeks.
Also known as: renion inhibitor placebo
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
Plan to share: Undecided
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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Shanghai Pharmaceuticals Holding Co., Ltd