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

NCT03756103 | Completed Phase 2 DMC

• 1 other identifier: SPH3127-201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 10

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.

Conditions

Hypertension,Essential

Keywords

mild-moderate essential hypertension; SPH3127 tablet; renin inhibitor; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 54-58 days

Secondary Outcomes (5)

• Changes from Baseline in Seated SBP and DBP after 2, 4 and 6 Weeks of Treatment.

  Baseline to 14±2, 28±2 and 42±2 days

• Changes from Baseline in 24-hour Ambulatory Blood Pressure after 8 Weeks of Treatment.

  Baseline to 54-58 days

• Effectiveness Rate after 4 and 8 Weeks of Treatment.

  Baseline to 28±2 and 56±2 days

• Hypertension Controlled Rates after 4 and 8 Weeks of Treatment.

  Baseline to 28±2 and 56±2 days

• Changes from Baseline in Plasma Renin Activity (PRA) Following 2, 4, 6 and 8 Weeks of Treatment.

  Baseline to 14±2, 28±2,42±2 and 56±2 days

Study Arms (4)

SPH3127 tablet Dose 1

EXPERIMENTAL

Low-dose group

Drug: SPH3127 tablet Dose 1

SPH3127 tablet Dose 2

EXPERIMENTAL

Mid-dose group

Drug: SPH3127 tablet Dose 2

SPH3127 tablet Dose 3

EXPERIMENTAL

High-dose group

Drug: SPH3127 tablet Dose 3

SPH3127 tablet Placebo

PLACEBO COMPARATOR

Placebo Control group

Drug: SPH3127 tablet Placebo

Interventions

SPH3127 tablet Dose 1 DRUG

Oral SPH3127 tablet, a kind of renion inhibitor, 50 mg, once daily for 8 weeks.

Also known as: renion inhibitor

SPH3127 tablet Dose 1

SPH3127 tablet Dose 2 DRUG

Oral SPH3127 tablet, a kind of renion inhibitor, 100 mg, once daily for 8 weeks.

Also known as: renion inhibitor

SPH3127 tablet Dose 2

SPH3127 tablet Dose 3 DRUG

Oral SPH3127 tablet, a kind of renion inhibitor, 200 mg, once daily for 8 weeks.

Also known as: renion inhibitor

SPH3127 tablet Dose 3

SPH3127 tablet Placebo DRUG

Oral SPH3127 tablet placebo, once daily for 8 weeks.

Also known as: renion inhibitor placebo

SPH3127 tablet Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Chinese
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead
• R&G Pharma Studies Co.,Ltd.: collaborator

Study Sites (10)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

Beijing Hospital

Beijing, China

Location

The Second Xiangya Hospital of Central South University

Changsha, China

Location

Xiangya Hospital Central South University

Changsha, China

Location

West China Hospital of Sichuan University

Chengdu, China

Location

Second People's Hospital of Guangdong Province

Guangdong, China

Location

Inner Mongolia Medical University Affiliated Hospital

Hohhot, China

Location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

Xuzhou Central Hospital

Xuzhou, China

Location

Related Publications (1)

• Wang F, Liu L, Ruan H, Chen X, Zhang Y, Yu Z, Li Y, Guan Y, Wang J, Huang K, Yu S, Cao Y, Ding C, Chang L, Huang Y, Chen X, Lv Q, Ma C. A randomized, double-blind, placebo-controlled, phase IIa, clinical study on investigating the efficacy and safety of SPH3127 tablet in patients with essential hypertension. Hypertens Res. 2024 Jul;47(7):1925-1933. doi: 10.1038/s41440-024-01657-z. Epub 2024 Apr 17.

  PMID: 38632457 DERIVED

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Changsheng Ma, Doctor

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 28, 2018
• Study Start: January 11, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 15, 2021

Record last verified: 2021-11

Locations

CN (10)