CClinicalTrials.gg
CompletedNCT03756103Updated Nov 15, 2021

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

A Phase 2 interventional study of SPH3127 tablet Dose 1 and SPH3127 tablet Dose 2 in Hypertension,Essential, sponsored by Shanghai Pharmaceuticals Holding Co., Ltd. Completed at 10 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-11-15.

Sponsored by Shanghai Pharmaceuticals Holding Co., Ltd · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertension,Essential

Keywords

  • mild-moderate essential hypertension
  • SPH3127 tablet
  • renin inhibitor
  • efficacy
  • safety
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 120 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd is the lead sponsor of 35 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    SPH3127 tablet Dose 1

    Low-dose group

    Drug: SPH3127 tablet Dose 1

  • Experimental
    SPH3127 tablet Dose 2

    Mid-dose group

    Drug: SPH3127 tablet Dose 2

  • Experimental
    SPH3127 tablet Dose 3

    High-dose group

    Drug: SPH3127 tablet Dose 3

  • Placebo comparator
    SPH3127 tablet Placebo

    Placebo Control group

    Drug: SPH3127 tablet Placebo

Interventions

  • DrugSPH3127 tablet Dose 1

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

    Also known as: renion inhibitor

  • DrugSPH3127 tablet Dose 2

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

    Also known as: renion inhibitor

  • DrugSPH3127 tablet Dose 3

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

    Also known as: renion inhibitor

  • DrugSPH3127 tablet Placebo

    Oral SPH3127 tablet placebo, once daily for 8 weeks.

    Also known as: renion inhibitor placebo

06

What researchers measure

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.

    Time frame: Baseline to 54-58 days

Secondary outcomes

  1. 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.

    Time frame: Baseline to 14±2, 28±2 and 42±2 days

  2. 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.

    Time frame: Baseline to 54-58 days

  3. 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.

    Time frame: Baseline to 28±2 and 56±2 days

  4. 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.

    Time frame: Baseline to 28±2 and 56±2 days

  5. 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.

    Time frame: Baseline to 14±2, 28±2,42±2 and 56±2 days

07

Study locations

10 sites
  • Beijing Anzhen Hospital, Capital Medical University
    Beijing, China
  • Beijing Hospital
    Beijing, China
  • The Second Xiangya Hospital of Central South University
    Changsha, China
  • Xiangya Hospital Central South University
    Changsha, China
  • West China Hospital of Sichuan University
    Chengdu, China
  • Second People's Hospital of Guangdong Province
    Guangdong, China
  • Inner Mongolia Medical University Affiliated Hospital
    Hohhot, China
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, China
  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, China
  • Xuzhou Central Hospital
    Xuzhou, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03756103
Lead sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Collaborators
R&G Pharma Studies Co.,Ltd.
Responsible party
Sponsor
First posted
Nov 28, 2018
Start date
Jan 11, 2019
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020
Last update
Nov 15, 2021

Study contacts

Changsheng Ma, Doctor
principal investigator · Beijing Anzhen Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion