Last updated: August 30, 2021
Sponsor: Shenzhen People's Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
High Blood Pressure (Hypertension)
High Blood Pressure (Hypertension - Pediatric)
Diabetes And Hypertension
Treatment
N/AClinical Study ID
NCT05033535
S086 Treat hypertension
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- For mild to moderate essential hypertension
- not receiving treatment or being treated with antihypertensive drugs (single drug orcombination therapy of two drugs, including compound preparations containing 2 drugcomponents)
- not receiving treatment (newly diagnosed Essential hypertension or a history ofhypertension but not taking any antihypertensive drugs at least 4 weeks beforescreening), during the screening period (V1) and before randomization (V4), the meansitting systolic blood pressure (msSBP) ≥ 150mmHg and <180mmHg;
- patients who are receiving antihypertensive drugs (treated with antihypertensive drugswithin 4 weeks before screening), at the end of the wash period (V2), must meet theaverage 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) mustbe the difference between the previous average sitting systolic pressure (at the endof the washing period (V2)) ≤15mmHg; voluntarily participate in the trial and sign aninformed consent form.
Exclusion
Exclusion Criteria:
- Have a history of allergies to relevant components of the test drug, known orsuspected to be allergic to S086, sacubatril, valsartan sodium or olmesartan medoxomiland related drugs (ARB, ACEI, and renin inhibitors);
- currently in pregnancy, breastfeeding Female subjects whose pregnancy or pregnancytests are positive; or those whose subjects or their partners cannot guaranteeeffective contraception during the trial period (acceptable methods of contraception:true abstinence; intrauterine contraceptive devices; barrier contraceptives; orpartners accepted Sterilization surgery. Unacceptable contraceptive methods: periodicabstinence, such as contraception based on calendar, ovulation, symptomatic bodytemperature);
- 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 screeningHistory: Participated in any drug or medical device or other clinical trial within 3months before screening, or participated in any drug or medical device or otherclinical trial during the planned trial or within 3 months after the end of the trial.
Study Design
Total Participants: 10
Study Start date:
July 01, 2020
Estimated Completion Date:
June 30, 2022
Connect with a study center
Shenzhen People' S Hospital
Shenzhen, Guangdong 518000
ChinaActive - Recruiting
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