Safety and Effect Study of SHR0532 (Drug Code) Tablets in Patients With Mild Hypertension

NCT03971929 | Completed Phase 1

• 1 other identifier: SHR0532-102
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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)

  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)

  Baseline to end of the study (up to 32 days)

• Change from baseline in 24h Urine sodium

  from baseline to Day 8; from D28 to D32 (up to 32 days)

• Change from baseline in 24h Urine Volume

  from baseline to Day 8; from D28 to D32 (up to 32 days)

Study Arms (3)

SHR0532 tablet

EXPERIMENTAL

up to 3 cohorts of subjects will receive multiple dose of oral tablets

Drug: SHR0532

SHR0532 placebo

PLACEBO COMPARATOR

up to 3 cohorts of subjects will receive multiple dose of oral SHR0532 placebo

Drug: SHR placebo

Hydrochlorothiazide

ACTIVE COMPARATOR

up to 3 cohorts of subjects will receive multiple dose of oral Hydrochlorothiazide 25mg

Drug: Hydrochlorothiazide 25 mg

Interventions

SHR0532 DRUG

once daily(QD) for 4weeks

SHR0532 tablet

SHR placebo DRUG

once daily(QD) for 4weeks

SHR0532 placebo

Hydrochlorothiazide 25 mg DRUG

once daily(QD) for 4weeks

Hydrochlorothiazide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females between 18 to 65 years old
• Diagnosis of mild hypertension
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Hangzhou, 310009, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 3, 2019
• Study Start: July 31, 2019
• Primary Completion: September 3, 2020
• Study Completion: September 3, 2020
• Last Updated: October 18, 2021

Record last verified: 2019-05

Locations

CN (1)