Hypertension,EssentialPhase 2NCT03756103
Safety and Efficacy of SPH3127 on Treating Mild-moderate Essential Hypertension Patients
A Phase 2 study testing SPH3127 tablet Dose 1, SPH3127 tablet Dose 2 and SPH3127 tablet Dose 3 in people with Hypertension,Essential, run by Shanghai Pharmaceuticals Holding Co., Ltd at 10 sites in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension,Essential
- What is being tested?
- SPH3127 tablet Dose 1, SPH3127 tablet Dose 2 and SPH3127 tablet Dose 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 10 sitesChina
- Study dates
- 11 Jan 2019to 30 Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing
Beijing Hospital
Beijing
The Second Xiangya Hospital of Central South University
Changsha
Xiangya Hospital Central South University
Changsha
West China Hospital of Sichuan University
Chengdu
Second People's Hospital of Guangdong Province
Guangdong
Inner Mongolia Medical University Affiliated Hospital
Hohhot
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Xuzhou Central Hospital
Xuzhou
About this study
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
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.
- Conditions
- Hypertension,Essential
- Being tested
- SPH3127 tablet Dose 1, SPH3127 tablet Dose 2, SPH3127 tablet Dose 3, SPH3127 tablet Placebo
- Keywords
- mild-moderate essential hypertension, SPH3127 tablet, renin inhibitor, efficacy, safety
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPH3127 tablet Dose 1Drug
Also called renion inhibitor
Oral SPH3127 tablet, a kind of renion inhibitor, 50 mg, once daily for 8 weeks.
SPH3127 tablet Dose 2Drug
Also called renion inhibitor
Oral SPH3127 tablet, a kind of renion inhibitor, 100 mg, once daily for 8 weeks.
SPH3127 tablet Dose 3Drug
Also called renion inhibitor
Oral SPH3127 tablet, a kind of renion inhibitor, 200 mg, once daily for 8 weeks.
SPH3127 tablet PlaceboDrug
Also called renion inhibitor placebo
Oral SPH3127 tablet placebo, once daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SPH3127 tablet Dose 1 | Experimental | Low-dose group Receives: Drug: SPH3127 tablet Dose 1 |
| SPH3127 tablet Dose 2 | Experimental | Mid-dose group Receives: Drug: SPH3127 tablet Dose 2 |
| SPH3127 tablet Dose 3 | Experimental | High-dose group Receives: Drug: SPH3127 tablet Dose 3 |
| SPH3127 tablet Placebo | Placebo comparator | Placebo Control group Receives: Drug: SPH3127 tablet Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 54-58 days
Secondary outcomes (5)
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.
Measured: Baseline to 14±2, 28±2 and 42±2 days
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.
Measured: Baseline to 54-58 days
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.
Measured: Baseline to 28±2 and 56±2 days
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.
Measured: 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.
To compare the changes of plasma renin activity (PRA) in each group after 2, 4, 6 and 8 weeks of treatment.
Measured: Baseline to 14±2, 28±2,42±2 and 56±2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start11 Jan 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- More trials run by Shanghai Pharmaceuticals Holding Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- R&G Pharma Studies Co.,Ltd.
- Responsible party
- Sponsor
- Investigators
- Changsheng Ma, Doctor, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756103
- Sponsor's protocol ID
- SPH3127-201
- Status last verified
- Nov 2021
- First submitted
- 16 Nov 2018
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38632457
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03756103
- Acronym / sponsor ID
- SPH3127-201
- Conditions
- Hypertension,Essential
- Keywords
- mild-moderate essential hypertension, SPH3127 tablet, renin inhibitor, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- R&G Pharma Studies Co.,Ltd.
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SPH3127 tablet Dose 1 | Experimental | Drug: SPH3127 tablet Dose 1Low-dose group |
| SPH3127 tablet Dose 2 | Experimental | Drug: SPH3127 tablet Dose 2Mid-dose group |
| SPH3127 tablet Dose 3 | Experimental | Drug: SPH3127 tablet Dose 3High-dose group |
| SPH3127 tablet Placebo | Placebo comparator | Drug: SPH3127 tablet PlaceboPlacebo Control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPH3127 tablet Dose 1Also: renion inhibitorOral SPH3127 tablet, a kind of renion inhibitor, 50 mg, once daily for 8 weeks. | Drug | SPH3127 tablet Dose 1 |
| SPH3127 tablet Dose 2Also: renion inhibitorOral SPH3127 tablet, a kind of renion inhibitor, 100 mg, once daily for 8 weeks. | Drug | SPH3127 tablet Dose 2 |
| SPH3127 tablet Dose 3Also: renion inhibitorOral SPH3127 tablet, a kind of renion inhibitor, 200 mg, once daily for 8 weeks. | Drug | SPH3127 tablet Dose 3 |
| SPH3127 tablet PlaceboAlso: renion inhibitor placeboOral SPH3127 tablet placebo, once daily for 8 weeks. | Drug | SPH3127 tablet Placebo |
Primary outcome
Changes From Baseline in Seated Systolic Blood Pressure (SBP) and Seated Diastolic Blood Pressure (DBP) After 8 Weeks of Treatment.
Time frame: Baseline to 54-58 days
To compare the changes of SBP and DBP after 8 weeks of treatment between each group.
5 secondary outcomes
Changes from Baseline in Seated SBP and DBP after 2, 4 and 6 Weeks of Treatment.
Time frame: Baseline to 14±2, 28±2 and 42±2 days
Changes from Baseline in 24-hour Ambulatory Blood Pressure after 8 Weeks of Treatment.
Time frame: Baseline to 54-58 days
Effectiveness Rate after 4 and 8 Weeks of Treatment.
Time frame: Baseline to 28±2 and 56±2 days
Hypertension Controlled Rates after 4 and 8 Weeks of Treatment.
Time frame: 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.
Time frame: Baseline to 14±2, 28±2,42±2 and 56±2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Derived from this study: PubMed 38632457Wang 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.
- Individual participant dataSharing planned: Undecided
Related trials for Hypertension,Essential
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changsheng Ma, Doctor principal investigator
Beijing Anzhen Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPH3127 tablet Dose 1, SPH3127 tablet Dose 2 and SPH3127 tablet Dose 3 in people with Hypertension,Essential, run by Shanghai Pharmaceuticals Holding Co., Ltd at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes From Baseline in Seated Systolic Blood Pressure (SBP) and Seated Diastolic Blood Pressure (DBP) After 8 Weeks of Treatment. (time frame: Baseline to 54-58 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03756103, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.