Efficacy and Safety of SPH3127 Tablet, a Novel Direct Renin Inhibitor, in Patients with Mild-to-Moderate Essential Hypertension: A Phase III Randomised Trial - PubMed
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- Phase III trial compared efficacy and safety of SPH3127 (a direct renin inhibitor) against valsartan in patients with mild-to-moderate essential hypertension over 12 weeks.
- The 100 mg dose of SPH3127 was selected after stage 1 for stage 2 based on high plasma renin activity inhibition (83%) and significant reduction in diastolic blood pressure.
- In stage 2, SPH3127 100 mg demonstrated non-inferiority to valsartan 80 mg in reducing mean sitting diastolic blood pressure, with similar safety profiles and adverse event rates.
- Adverse drug reactions were slightly lower with SPH3127 (8.3%) compared to valsartan (10.0%), with no serious adverse events linked to the investigational drugs.
- The study concludes that oral SPH3127 100 mg once daily is an effective and safe treatment option for adults with mild-to-moderate essential hypertension.