HypertensionPhase 1NCT03971929
Safety and Effect Study of SHR0532 (Drug Code) Tablets in Patients With Mild Hypertension
A Phase 1 study testing SHR0532 and Hydrochlorothiazide 25 mg in people with Hypertension, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety and efficacy and Pharmacokinetics/Pharmacodynamics of SHR0532 in subjects with mild hypertension for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- SHR0532 and Hydrochlorothiazide 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2019to 3 Sep 2020
- Phase
- Phase 1
- 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
- Males or females between 18 to 65 years old
- Diagnosis of mild hypertension
- 18.5 kg/m2≤Body mass index (BMI) ≤35 kg/m^2
- Understand the study procedure and method, willing to participate the study and Informed consent form (ICF) signed in writing
Who cannot join
- History of significant drug allergy or allergic diseases (asthma, urticaria, eczematous dermatitis), or known allergy to anti hypertension drugs
- Anti-hypertensive drugs were taken within 1 month before screening
- History or at present patient has orthostatic hypotension
- History or at screening Participant has plasma sodium lower than 135mmol/L
- History or at screening visit/baseline patient has elevated serum uric acid (serum uric acid higher than ULN)
- Patients with type 1 diabetes mellitus need insulin therapy or poor blood glucose control (HbA1c > 9%, or oral anti diabetic drug dosage is not stable within 4 weeks before screening)
Show all 32Show fewer
- History of arrhythmia or patient has clinically significant abnormalities of 12-lead ECG or prolonged corrected QT (QTc) interval (male > 450ms; female > 460ms) at screening visit
- History of New York Heart Association (NYHA) Definition II-IV Heart Failure
- Severe cardiovascular diseases occurred within 6 months before screening, including ischemic heart disease, peripheral vascular disease, significant ventricular tachycardia, atrial fibrillation, atrial flutter or other serious arrhythmias, hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, aortic or mitral valve disease of great hemodynamic significance, and severe cerebrovascular disease
- History of percutaneous intervention (PCI) or coronary artery bypass graft (CABG)
- History or active stroke, chronic seizures, or major neurological disorder
- History of osteoporosis, nephrocalcinosis, nephrolithiasis or hypercalciuria
- History or active malignant neoplastic disease. Exceptions: malignancies which have been successfully treated and non-recurrence >10 years prior to the screening visit
- Patients having following diseases may affect drug absorption, distribution, metabolism and excretion:
- Gastrointestinal diseases such as irritable bowel syndrome, inflammatory bowel diseases including ulcerative colitis, Crohn's disease, malabsorption syndrome, microbial dysbiosis, intestinal infection; History of gastrointestinal operations, such as gastric resection and bypass, small intestinal resection and colonic resection which may affect drug absorption
- History of acute or chronic kidney diseases
- Dehydration or volume-depletion
- Clinically significant chronic or acute infectious diseases occur within 2 weeks before the start of the study (enrolment);
- Major surgery within 3 months before dosing
- Donation of blood/plasma within 1 month before dosing or blood/plasma (≥400 mL) within 3 months before dosing
- Unstable or severe urinary, digestive, psychiatric, neural, hematological and other diseases, or lab abnormalities, the investigators determine that participants in the study will be at unacceptable risk
- Taking or having the following medication history:
- Participant need taking Cytochrome P450 3A4 (CYP3A4) inhibitors (such as ritonavir, indinavir, nelfinavir, erythromycin, telithromycin, clarithromycin, chloramphenicol, fluconazole, ketoconazole, itraconazole, verapamil or diltiazem) as well as strong/moderate CYP3A4 inducers (such as phenytoin, carbamazepine, oxcarbazepine, phenobarbital, efavirenz, nevirapine, rifampicin, modafinil, cyproterone or progestin) at least 2 weeks or 5 half-lives prior to administration of the initial dose of study drug until the post study visit
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) at least 2 weeks before 1st dose of study drug until the post study visit
- use of systemic glucocorticoid therapy
- Any laboratory examination result meet the following criteria at screening/baseline:
- Serum potassium < 3.5mmol/L or > 5.5mmol/L
- Serum creatinine more than ULN, Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 2.0 x ULN or total bilirubin more than 1.5 x ULN at screening/baseline visit
- Creatinine kinase (CK) more than 3.0 x ULN at screening/baseline visit;
- Clinically significant abnormalities of coagulation and thyroid function
- HbsAg and Hepatitis B Virus (HBV)-DNA> 1000 cps/ml, Hepatitis C Virus Antibody (HCVAb), syphilis and HIV antibodies were positive at screening visit
- Serum pregnant test positive at screening/baseline visit
Trial locations and contacts
1 site in 1 country.
China1 site
The second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Hangzhou, 310009
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-hydrochlorothiazide Parallel Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Efficacy of SHR 0532 Oral Tablets in Mild Hypertension Subjects
The study is being conducted to evaluate the safety and efficacy and Pharmacokinetics/Pharmacodynamics of SHR0532 in subjects with mild hypertension for 4 weeks.
Read the detailed description
This is a randomized, double-blind, multiple ascending dose, placebo- and Hydrochlorothiazide-controlled study to evaluate the safety and tolerability, Pharmacokinetics and Pharmacodynamics and effect on blood pressure of SHR0532 tablets in patients with mild hypertension.
- Conditions
- Hypertension
- Being tested
- SHR0532, SHR placebo, Hydrochlorothiazide 25 mg
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0532Drug
once daily(QD) for 4weeks
SHR placeboDrug
once daily(QD) for 4weeks
Hydrochlorothiazide 25 mgDrug
once daily(QD) for 4weeks
| Study group | Role | What they receive |
|---|---|---|
| SHR0532 tablet | Experimental | up to 3 cohorts of subjects will receive multiple dose of oral tablets Receives: Drug: SHR0532 |
| SHR0532 placebo | Placebo comparator | up to 3 cohorts of subjects will receive multiple dose of oral SHR0532 placebo Receives: Drug: SHR placebo |
| Hydrochlorothiazide | Active comparator | up to 3 cohorts of subjects will receive multiple dose of oral Hydrochlorothiazide 25mg Receives: Drug: Hydrochlorothiazide 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events(AEs) and Serious Adverse Events （SAEs）
Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events, incidence of drug related adverse events (safety and tolrability)
Measured: from informed consent form signature to the end of the study (up to 2 months)
Secondary outcomes (3)
Change From Baseline in Clinic Systolic Blood Pressure (SBP) and Clinic Diastolic Blood Pressure (DBP)
Each subject has their office blood pressure every day of each treatment period (total of 28 days of treatment). The difference between baseline and D28 of each office BP value are calculated and recorded.
Measured: Baseline to end of the study (up to 32 days)
Change from baseline in 24h Urine sodium
Urine sodium (Na) levels were measured over 24-hours and different time period of 24 hours on Day -1 (baseline) and on Day 1to Day 7, Day28 to Day 32. The total amount of Na excreted in the Urine for Day-1 (baseline) and Day1 to Day 7, Day 28 to Day 32 were calculated and recorded and the difference between the 2 values are recorded.
Measured: from baseline to Day 8; from D28 to D32 (up to 32 days)
Change from baseline in 24h Urine Volume
Urine Volume were measured over 24-hours and different time period of 24 hours on Day -1 (baseline) and on Day 1to Day 7, Day28 to Day 32.The total amount of Urine excreted for Day-1 (baseline) and Day1 to Day 7, Day 28 to Day 32 were calculated and recorded and the difference between the 2 values are recorded.
Measured: from baseline to Day 8; from D28 to D32 (up to 32 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start31 Jul 2019
- Primary completion3 Sep 2020
- Study completion3 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971929
- Sponsor's protocol ID
- SHR0532-102
- Status last verified
- May 2019
- First submitted
- 28 May 2019
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-hydrochlorothiazide Parallel Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Efficacy of SHR 0532 Oral Tablets in Mild Hypertension Subjects
- ClinicalTrials.gov ID
- NCT03971929
- Acronym / sponsor ID
- SHR0532-102
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 3 Sep 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 3 Jun 2019 (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.
The study is being conducted to evaluate the safety and efficacy and Pharmacokinetics/Pharmacodynamics of SHR0532 in subjects with mild hypertension for 4 weeks.
Detailed description
This is a randomized, double-blind, multiple ascending dose, placebo- and Hydrochlorothiazide-controlled study to evaluate the safety and tolerability, Pharmacokinetics and Pharmacodynamics and effect on blood pressure of SHR0532 tablets in patients with mild hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHR0532 tablet | Experimental | Drug: SHR0532up to 3 cohorts of subjects will receive multiple dose of oral tablets |
| SHR0532 placebo | Placebo comparator | Drug: SHR placeboup to 3 cohorts of subjects will receive multiple dose of oral SHR0532 placebo |
| Hydrochlorothiazide | Active comparator | Drug: Hydrochlorothiazide 25 mgup to 3 cohorts of subjects will receive multiple dose of oral Hydrochlorothiazide 25mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females between 18 to 65 years old
- Diagnosis of mild hypertension
- 18.5 kg/m2≤Body mass index (BMI) ≤35 kg/m^2
- Understand the study procedure and method, willing to participate the study and Informed consent form (ICF) signed in writing
Key exclusion criteria (32 listed)
- History of significant drug allergy or allergic diseases (asthma, urticaria, eczematous dermatitis), or known allergy to anti hypertension drugs
- Anti-hypertensive drugs were taken within 1 month before screening
- History or at present patient has orthostatic hypotension
- History or at screening Participant has plasma sodium lower than 135mmol/L
- History or at screening visit/baseline patient has elevated serum uric acid (serum uric acid higher than ULN)
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 |
|---|---|---|
| SHR0532once daily(QD) for 4weeks | Drug | SHR0532 tablet |
| SHR placeboonce daily(QD) for 4weeks | Drug | SHR0532 placebo |
| Hydrochlorothiazide 25 mgonce daily(QD) for 4weeks | Drug | Hydrochlorothiazide |
Primary outcome
Adverse Events(AEs) and Serious Adverse Events （SAEs）
Time frame: from informed consent form signature to the end of the study (up to 2 months)
Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events, incidence of drug related adverse events (safety and tolrability)
3 secondary outcomes
Change From Baseline in Clinic Systolic Blood Pressure (SBP) and Clinic Diastolic Blood Pressure (DBP)
Time frame: Baseline to end of the study (up to 32 days)
Change from baseline in 24h Urine sodium
Time frame: from baseline to Day 8; from D28 to D32 (up to 32 days)
Change from baseline in 24h Urine Volume
Time frame: from baseline to Day 8; from D28 to D32 (up to 32 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 18 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR0532 and Hydrochlorothiazide 25 mg in people with Hypertension, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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 32 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 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse Events(AEs) and Serious Adverse Events （SAEs） (time frame: from informed consent form signature to the end of the study (up to 2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2021.