s086 Tablets in the Treatment of Mild to Moderate Essential Hypertension
Primary Purpose
Essential Hypertension
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sacubatril Allisartan medoxomil
Olmesartan Medoxomil
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension
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.
Sites / Locations
- Shenzhen People' S HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
S086
Olmesartan medoxomil
Arm Description
S086 PLCEBO
Outcomes
Primary Outcome Measures
sitting systolic blood pressure (msSBP)
sitting systolic blood pressure (msSBP) at the 8th weekend from baseline
Secondary Outcome Measures
sitting Diastolic blood pressure (msDBP)
sitting Diastolic blood pressure (msDBP) at the 8th weekend from baseline
Compliance rate
Compliance rate of pressure reduction at the 8th weekend
Full Information
NCT ID
NCT05033535
First Posted
August 25, 2021
Last Updated
August 30, 2021
Sponsor
Shenzhen People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05033535
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
S086
Arm Type
Experimental
Arm Title
Olmesartan medoxomil
Arm Type
Placebo Comparator
Arm Description
S086 PLCEBO
Intervention Type
Drug
Intervention Name(s)
Sacubatril Allisartan medoxomil
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Olmesartan Medoxomil
Other Intervention Name(s)
Efficacy for lowering blood pressure of Olmesartan medoxomil
Intervention Description
Efficacy for lowering blood pressure of Olmesartan medoxomil
Primary Outcome Measure Information:
Title
sitting systolic blood pressure (msSBP)
Description
sitting systolic blood pressure (msSBP) at the 8th weekend from baseline
Time Frame
8 weeks after baseline
Secondary Outcome Measure Information:
Title
sitting Diastolic blood pressure (msDBP)
Description
sitting Diastolic blood pressure (msDBP) at the 8th weekend from baseline
Time Frame
8 weeks after baseline
Title
Compliance rate
Description
Compliance rate of pressure reduction at the 8th weekend
Time Frame
8 weeks after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junbo He
Phone
13434792084
Email
527768709@qq.com
Facility Information:
Facility Name
Shenzhen People' S Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junbo He
Phone
13434792084
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
s086 Tablets in the Treatment of Mild to Moderate Essential Hypertension
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