s086 Tablets in the Treatment of Mild to Moderate Essential Hypertension

Sponsor

Shenzhen People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05033535

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: Sacubatril Allisartan medoxomil Drug: Olmesartan Medoxomil	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: S086	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
Placebo Comparator: Olmesartan medoxomil S086 PLCEBO	Drug: Olmesartan Medoxomil Efficacy for lowering blood pressure of Olmesartan medoxomil Other Names: Efficacy for lowering blood pressure of Olmesartan medoxomil

Arm

Intervention/Treatment

Experimental: S086

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

Placebo Comparator: Olmesartan medoxomil

S086 PLCEBO

Drug: Olmesartan Medoxomil

Efficacy for lowering blood pressure of Olmesartan medoxomil

Other Names:

Efficacy for lowering blood pressure of Olmesartan medoxomil

Outcome Measures

Primary Outcome Measures

sitting systolic blood pressure (msSBP) [8 weeks after baseline]
sitting systolic blood pressure (msSBP) at the 8th weekend from baseline

Secondary Outcome Measures

sitting Diastolic blood pressure (msDBP) [8 weeks after baseline]
sitting Diastolic blood pressure (msDBP) at the 8th weekend from baseline
Compliance rate [8 weeks after baseline]
Compliance rate of pressure reduction at the 8th weekend

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shenzhen People' S Hospital	Shenzhen	Guangdong	China	518000

Sponsors and Collaborators

Shenzhen People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shenzhen People's Hospital

ClinicalTrials.gov Identifier:

NCT05033535

Other Study ID Numbers:

S086 Treat hypertension

First Posted:

Sep 5, 2021

Last Update Posted:

Sep 5, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Essential Hypertension

Olmesartan

Olmesartan Medoxomil

Study Results

No Results Posted as of Sep 5, 2021