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Safety and Efficacy of SPH3127 on Treating Mild-moderate Essential Hypertension Patients

Primary Purpose

Hypertension,Essential

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SPH3127 tablet Dose 1
SPH3127 tablet Dose 2
SPH3127 tablet Dose 3
SPH3127 tablet Placebo
Sponsored by
Shanghai Pharmaceuticals Holding Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension,Essential focused on measuring mild-moderate essential hypertension, SPH3127 tablet, renin inhibitor, efficacy, safety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female who is 18 - 65 years old.
  2. Subject who is meeting the diagnostic criteria of mild-moderate essential hypertension:mean seated Systolic Blood Pressure (SBP) (2~3 times average) ≥ 140 mmHg and ≤ 179 mmHg and mean seated Diastolic Blood Pressure (DBP) (2~3 times average)≥ 90 and ≤ 109 mmHg.
  3. Laboratory testing should:

(1) GFR* ≥ 60mL/min (2) AST or ALT is less than 2 times upper limit of normal (3) Hemoglobin ≥ 90g/L (4) Serum potassium ≥ 3.5mmol/L and ≤ 5.5mmol/L *the conversion formulas for GFR* Male:GFR=186×(Scr)^-1.154×(age)^-0.203; Female:GFR=186×(Scr)^-1.154×(age)^-0.203×0.742; Serum creatinine(Scr) unit:µmol/L.

Exclusion Criteria:

  1. Subject who is diagnosed as a secondary hypertension.
  2. Subject who is suspected to be malignant hypertension, hypertensive emergency, hypertensive urgencies patients.
  3. Subject who is at risk when the current anti-hypertensive therapy discontinued.
  4. Subject who is suffered by chronic congestive heart failure (NYHA III and IV) or myocardial infarction within 6 months. Subject has had or is currently suffered by serious heart disease, such as unstable angina, cardiogenic shock, arrhythmia to that needs treatment, heart valve disease, hypertrophic cardiomyopathy, rheumatic heart disease, etc.
  5. Subject who is suffered by severe cerebrovascular disease or shock within 6 months, such as hypertensive encephalopathy, cerebrovascular injury, cerebral hemorrhage, transient ischemic attack etc.
  6. Subject who is suffered by severe or malignant retinopathy. The severe lesions is defined as retinal hemorrhage, micro aneurysm, cotton wool patches, hard exudate or a combination of these symptoms. The malignant lesions defined as the combination of severe retinopathy and optic disc edema.
  7. Subject's medication compliance is not suitable for this trial (use of medication is <80% or >120% in the leading phase).
  8. Subject whose work is associated with such condition as work at height, motor driver or operating dangerous machine etc.
  9. Subject who is suffered by aorta-arteritis, large aneurysm or aortic dissection, severe subclavian artery stenosis in the past.
  10. Subject who had a gastrointestinal surgery history that may significantly alter drug absorption, distribution, metabolism and excretion(For example: gastroectomy, gastroenteroanastomosis or enterectomy, gastric bypass, gastrointestinal anastomosis, gastrointestinal band surgery, etc.).
  11. Subject who have drug allergy history and anaphylactic reaction.
  12. Subject who is lactating, or is planning to pregnant within six months after the trial.
  13. Subject whose diabetes is out of controlled. Defined as fasting blood-glucose is > 7.8 mmol/L or glycosylated hemoglobin is>7.5%.
  14. Subject who has a history of malignant tumor.
  15. Subject who has a history of mental disorders.
  16. Subject who has abnormal thyroid function examination or abnormal urine protein check value in urine routine(Urine protein test result is a "+" is considered abnormal).
  17. Subject who has participated clinical trials within past 3 months (as a subject).
  18. Subject who is planning or in use of other non-antihypertensive drugs which may affect blood pressure(for example: Monoamine oxidase inhibitors, anesthetics, tricyclic and tetracyclic antidepressants, non-steroidal anti-inflammatory drugs, reproductive oral contraceptive pills, thyroid hormones, adrenocortical hormones, etc.).
  19. Subject who is planning or in use of other antihypertensive drugs during the trial.
  20. Subject who is alcohol abuse (adult male/female consume more than 25g of alcohol per day: 25g of alcohol is equivalent to 200 mL of yellow rice wine/wine (15 degrees), 780mL of beer (4 degrees), 62 mL of liquor (50 degrees)) or drug abuse.
  21. Subject that investigators considered to be not suitable for this study.

Sites / Locations

  • Beijing Anzhen Hospital, Capital Medical University
  • Beijing Hospital
  • The Second Xiangya Hospital of Central South University
  • Xiangya Hospital Central South University
  • West China Hospital of Sichuan University
  • Second People's Hospital of Guangdong Province
  • Inner Mongolia Medical University Affiliated Hospital
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Xuzhou Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

SPH3127 tablet Dose 1

SPH3127 tablet Dose 2

SPH3127 tablet Dose 3

SPH3127 tablet Placebo

Arm Description

Low-dose group

Mid-dose group

High-dose group

Placebo Control group

Outcomes

Primary Outcome Measures

Changes From Baseline in Seated Systolic Blood Pressure (SBP) and Seated Diastolic Blood Pressure (DBP) After 8 Weeks of Treatment.
To compare the changes of SBP and DBP after 8 weeks of treatment between each group.

Secondary Outcome Measures

Changes from Baseline in Seated SBP and DBP after 2, 4 and 6 Weeks of Treatment.
To compare the changes of seated SBP and DBP after 2, 4 and 6 weeks of treatment between each group.
Changes from Baseline in 24-hour Ambulatory Blood Pressure after 8 Weeks of Treatment.
To compare the change from baseline in 24-hour ambulatory blood pressure in each group after 8 weeks of treatment.
Effectiveness Rate after 4 and 8 Weeks of Treatment.
To compare the rates that SBP decreased more than 20 mmHg or DBP decreased more than 10 mmHg between each group after 4 and 8 weeks of treatment.
Hypertension Controlled Rates after 4 and 8 Weeks of Treatment.
To compare the rates that seated SBP < 140 mmHg and DBP < 90 mmHg between each group after 4 and 8 weeks of treatment.
Changes from Baseline in Plasma Renin Activity (PRA) Following 2, 4, 6 and 8 Weeks of Treatment.
To compare the changes of plasma renin activity (PRA) in each group after 2, 4, 6 and 8 weeks of treatment.

Full Information

First Posted
November 16, 2018
Last Updated
November 11, 2021
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Collaborators
R&G Pharma Studies Co.,Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03756103
Brief Title
Safety and Efficacy of SPH3127 on Treating Mild-moderate Essential Hypertension Patients
Official Title
To Evaluate the Safety and Efficacy of SPH3127 on Treating Mild-moderate Essential Hypertension Patients: A Randomized, Double-Blinded, Dose-Exploration and Placebo-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Collaborators
R&G Pharma Studies Co.,Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
SPH3127 tablet is a of renin inhibitor. It is expected to be a new drug for essential hypertension. This is a phase IIa trial which designed to evaluate its efficacy and safety on treating mild-moderate essential hypertension patients.
Detailed Description
This is a dose finding trial. Totally 120 mild-moderate essential hypertension patients will be enrolled. All the patients will be randomized (1:1:1:1) into four groups (SPH3127 50mg, SPH3127 100mg, SPH3127 200mg and placebo). The trial has three phases: the screening phase, the leading phase and the treating phase. The primary endpoints are the changes of DBP and SBP compared to the baseline after 8 weeks of treatment. All the adverse events are required to be collected for safety analyzing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,Essential
Keywords
mild-moderate essential hypertension, SPH3127 tablet, renin inhibitor, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPH3127 tablet Dose 1
Arm Type
Experimental
Arm Description
Low-dose group
Arm Title
SPH3127 tablet Dose 2
Arm Type
Experimental
Arm Description
Mid-dose group
Arm Title
SPH3127 tablet Dose 3
Arm Type
Experimental
Arm Description
High-dose group
Arm Title
SPH3127 tablet Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Control group
Intervention Type
Drug
Intervention Name(s)
SPH3127 tablet Dose 1
Other Intervention Name(s)
renion inhibitor
Intervention Description
Oral SPH3127 tablet, a kind of renion inhibitor, 50 mg, once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
SPH3127 tablet Dose 2
Other Intervention Name(s)
renion inhibitor
Intervention Description
Oral SPH3127 tablet, a kind of renion inhibitor, 100 mg, once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
SPH3127 tablet Dose 3
Other Intervention Name(s)
renion inhibitor
Intervention Description
Oral SPH3127 tablet, a kind of renion inhibitor, 200 mg, once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
SPH3127 tablet Placebo
Other Intervention Name(s)
renion inhibitor placebo
Intervention Description
Oral SPH3127 tablet placebo, once daily for 8 weeks.
Primary Outcome Measure Information:
Title
Changes From Baseline in Seated Systolic Blood Pressure (SBP) and Seated Diastolic Blood Pressure (DBP) After 8 Weeks of Treatment.
Description
To compare the changes of SBP and DBP after 8 weeks of treatment between each group.
Time Frame
Baseline to 54-58 days
Secondary Outcome Measure Information:
Title
Changes from Baseline in Seated SBP and DBP after 2, 4 and 6 Weeks of Treatment.
Description
To compare the changes of seated SBP and DBP after 2, 4 and 6 weeks of treatment between each group.
Time Frame
Baseline to 14±2, 28±2 and 42±2 days
Title
Changes from Baseline in 24-hour Ambulatory Blood Pressure after 8 Weeks of Treatment.
Description
To compare the change from baseline in 24-hour ambulatory blood pressure in each group after 8 weeks of treatment.
Time Frame
Baseline to 54-58 days
Title
Effectiveness Rate after 4 and 8 Weeks of Treatment.
Description
To compare the rates that SBP decreased more than 20 mmHg or DBP decreased more than 10 mmHg between each group after 4 and 8 weeks of treatment.
Time Frame
Baseline to 28±2 and 56±2 days
Title
Hypertension Controlled Rates after 4 and 8 Weeks of Treatment.
Description
To compare the rates that seated SBP < 140 mmHg and DBP < 90 mmHg between each group after 4 and 8 weeks of treatment.
Time Frame
Baseline to 28±2 and 56±2 days
Title
Changes from Baseline in Plasma Renin Activity (PRA) Following 2, 4, 6 and 8 Weeks of Treatment.
Description
To compare the changes of plasma renin activity (PRA) in each group after 2, 4, 6 and 8 weeks of treatment.
Time Frame
Baseline to 14±2, 28±2,42±2 and 56±2 days

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Chinese
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female who is 18 - 65 years old. Subject who is meeting the diagnostic criteria of mild-moderate essential hypertension:mean seated Systolic Blood Pressure (SBP) (2~3 times average) ≥ 140 mmHg and ≤ 179 mmHg and mean seated Diastolic Blood Pressure (DBP) (2~3 times average)≥ 90 and ≤ 109 mmHg. Laboratory testing should: (1) GFR* ≥ 60mL/min (2) AST or ALT is less than 2 times upper limit of normal (3) Hemoglobin ≥ 90g/L (4) Serum potassium ≥ 3.5mmol/L and ≤ 5.5mmol/L *the conversion formulas for GFR* Male:GFR=186×(Scr)^-1.154×(age)^-0.203; Female:GFR=186×(Scr)^-1.154×(age)^-0.203×0.742; Serum creatinine(Scr) unit:µmol/L. Exclusion Criteria: Subject who is diagnosed as a secondary hypertension. Subject who is suspected to be malignant hypertension, hypertensive emergency, hypertensive urgencies patients. Subject who is at risk when the current anti-hypertensive therapy discontinued. Subject who is suffered by chronic congestive heart failure (NYHA III and IV) or myocardial infarction within 6 months. Subject has had or is currently suffered by serious heart disease, such as unstable angina, cardiogenic shock, arrhythmia to that needs treatment, heart valve disease, hypertrophic cardiomyopathy, rheumatic heart disease, etc. Subject who is suffered by severe cerebrovascular disease or shock within 6 months, such as hypertensive encephalopathy, cerebrovascular injury, cerebral hemorrhage, transient ischemic attack etc. Subject who is suffered by severe or malignant retinopathy. The severe lesions is defined as retinal hemorrhage, micro aneurysm, cotton wool patches, hard exudate or a combination of these symptoms. The malignant lesions defined as the combination of severe retinopathy and optic disc edema. Subject's medication compliance is not suitable for this trial (use of medication is <80% or >120% in the leading phase). Subject whose work is associated with such condition as work at height, motor driver or operating dangerous machine etc. Subject who is suffered by aorta-arteritis, large aneurysm or aortic dissection, severe subclavian artery stenosis in the past. Subject who had a gastrointestinal surgery history that may significantly alter drug absorption, distribution, metabolism and excretion(For example: gastroectomy, gastroenteroanastomosis or enterectomy, gastric bypass, gastrointestinal anastomosis, gastrointestinal band surgery, etc.). Subject who have drug allergy history and anaphylactic reaction. Subject who is lactating, or is planning to pregnant within six months after the trial. Subject whose diabetes is out of controlled. Defined as fasting blood-glucose is > 7.8 mmol/L or glycosylated hemoglobin is>7.5%. Subject who has a history of malignant tumor. Subject who has a history of mental disorders. Subject who has abnormal thyroid function examination or abnormal urine protein check value in urine routine(Urine protein test result is a "+" is considered abnormal). Subject who has participated clinical trials within past 3 months (as a subject). Subject who is planning or in use of other non-antihypertensive drugs which may affect blood pressure(for example: Monoamine oxidase inhibitors, anesthetics, tricyclic and tetracyclic antidepressants, non-steroidal anti-inflammatory drugs, reproductive oral contraceptive pills, thyroid hormones, adrenocortical hormones, etc.). Subject who is planning or in use of other antihypertensive drugs during the trial. Subject who is alcohol abuse (adult male/female consume more than 25g of alcohol per day: 25g of alcohol is equivalent to 200 mL of yellow rice wine/wine (15 degrees), 780mL of beer (4 degrees), 62 mL of liquor (50 degrees)) or drug abuse. Subject that investigators considered to be not suitable for this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changsheng Ma, Doctor
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
Beijing Hospital
City
Beijing
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
Country
China
Facility Name
Second People's Hospital of Guangdong Province
City
Guangdong
Country
China
Facility Name
Inner Mongolia Medical University Affiliated Hospital
City
Hohhot
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Facility Name
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
Xuzhou Central Hospital
City
Xuzhou
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Safety and Efficacy of SPH3127 on Treating Mild-moderate Essential Hypertension Patients

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