s086 Tablets in the Treatment of Mild to Moderate Essential Hypertension

NCT05033535 | Unknown Phase 2

• 1 other identifier: S086 Treat hypertension
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• sitting systolic blood pressure (msSBP)

  sitting systolic blood pressure (msSBP) at the 8th weekend from baseline

  8 weeks after baseline

Secondary Outcomes (2)

• sitting Diastolic blood pressure (msDBP)

  8 weeks after baseline

• Compliance rate

  8 weeks after baseline

Study Arms (2)

S086

EXPERIMENTAL

Drug: Sacubatril Allisartan medoxomil

Olmesartan medoxomil

PLACEBO COMPARATOR

S086 PLCEBO

Drug: Olmesartan Medoxomil

Interventions

Sacubatril Allisartan medoxomil DRUG

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

S086

Olmesartan Medoxomil DRUG

Efficacy for lowering blood pressure of Olmesartan medoxomil

Also known as: Efficacy for lowering blood pressure of Olmesartan medoxomil

Olmesartan medoxomil

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People' S Hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Interventions

Olmesartan Medoxomil

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Central Study Contacts

Junbo He

CONTACT

13434792084; 527768709@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 5, 2021
• Study Start: July 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: June 30, 2022
• Last Updated: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)