Clinical trial NCT05033535: s086 Tablets in the Treatment of Mild to Moderate Essential Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Essential Hypertension
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: sitting systolic blood pressure (msSBP)
timeFrame: 8 weeks after baseline
Secondary outcomes:
measure: sitting Diastolic blood pressure (msDBP)
timeFrame: 8 weeks after baseline
measure: Compliance rate
timeFrame: 8 weeks after baseline
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People' S Hospital
state: Guangdong
Study officials:
References: