s086 Tablets in the Treatment of Mild to Moderate Essential Hypertension

Study Overview
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Brief Summary
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Efficacy and Safety of s086 Tablets in the Treatment of Mild to Moderate Essential Hypertension:a Randomized,Double-blind,Placebo-controlled,Multicenter Phase II Clinical Trial

Official Title
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Efficacy and Safety of s086 Tablets in the Treatment of Mild to Moderate Essential Hypertension:a Randomized,Double-blind,Placebo-controlled,Multicenter Phase II Clinical Trial

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: Sacubatril Allisartan medoxomil
* Drug: Olmesartan Medoxomil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For mild to moderate essential hypertension not receiving treatment or being treated with antihypertensive drugs (single drug or combination therapy of two drugs, including compound preparations containing 2 drug components) not receiving treatment (newly diagnosed Essential hypertension or a history of hypertension but not taking any antihypertensive drugs at least 4 weeks before screening), during the screening period (V1) and before randomization (V4), the mean sitting systolic blood pressure (msSBP) ≥ 150mmHg and <180mmHg; patients who are receiving antihypertensive drugs (treated with antihypertensive drugs within 4 weeks before screening), at the end of the wash period (V2), must meet the average sitting systolic blood pressure ≥140mmHg and <180mmHg; before randomization (V4), the average sitting systolic blood pressure must be ≥150mmHg and <180mmHg; the patient's average sitting systolic blood pressure before randomization (V4) must be the difference between the previous average sitting systolic pressure (at the end of the washing period (V2)) ≤15mmHg; voluntarily participate in the trial and sign an informed consent form. Exclusion Criteria: Have a history of allergies to relevant components of the test drug, known or suspected to be allergic to S086, sacubatril, valsartan sodium or olmesartan medoxomil and related drugs (ARB, ACEI, and renin inhibitors); currently in pregnancy, breastfeeding Female subjects whose pregnancy or pregnancy tests are positive; or those whose subjects or their partners cannot guarantee effective contraception during the trial period (acceptable methods of contraception: true abstinence; intrauterine contraceptive devices; barrier contraceptives; or partners accepted Sterilization surgery. Unacceptable contraceptive methods: periodic abstinence, such as contraception based on calendar, ovulation, symptomatic body temperature); or those who have a childbirth plan within 6 months after the end of the trial; have a history of drug abuse or alcohol abuse within 6 months before screening History: Participated in any drug or medical device or other clinical trial within 3 months before screening, or participated in any drug or medical device or other clinical trial during the planned trial or within 3 months after the end of the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S086<br> | Drug: Sacubatril Allisartan medoxomil<br>* Sacubatril Allisartan medoxomil ：A randomized, double-blind, placebo and positive drug parallel controlled, multi-center phase II clinical study on the effectiveness and safety of treating mild and moderate essential hypertension<br>|
| Placebo Comparator: Olmesartan medoxomil<br>S086 PLCEBO | Drug: Olmesartan Medoxomil<br>* Efficacy for lowering blood pressure of Olmesartan medoxomil<br>* Other names: Efficacy for lowering blood pressure of Olmesartan medoxomil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sitting systolic blood pressure (msSBP) | sitting systolic blood pressure (msSBP) at the 8th weekend from baseline | 8 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sitting Diastolic blood pressure (msDBP) | sitting Diastolic blood pressure (msDBP) at the 8th weekend from baseline | 8 weeks after baseline | 
| Compliance rate | Compliance rate of pressure reduction at the 8th weekend | 8 weeks after baseline |