s086 Tablets in the Treatment of Mild to Moderate Essential Hypertension

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05033535
• Other study ID #: S086 Treat hypertension
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2021
• Source: Shenzhen People's Hospital
• Contact: Junbo He
• Phone: 13434792084
• Email: 527768709[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 30, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Sacubatril Allisartan medoxomil
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
• Olmesartan Medoxomil
Efficacy for lowering blood pressure of Olmesartan medoxomil

Locations

Country	Name	City	State
China	Shenzhen People' S Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sitting systolic blood pressure (msSBP)	sitting systolic blood pressure (msSBP) at the 8th weekend from baseline	8 weeks after baseline
Secondary	sitting Diastolic blood pressure (msDBP)	sitting Diastolic blood pressure (msDBP) at the 8th weekend from baseline	8 weeks after baseline
Secondary	Compliance rate	Compliance rate of pressure reduction at the 8th weekend	8 weeks after baseline