The study is being conducted to evaluate the safety and efficacy and Pharmacokinetics/Pharmacodynamics of SHR0532 in subjects with mild hypertension for 4 weeks.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
once daily(QD) for 4weeks
once daily(QD) for 4weeks
once daily(QD) for 4weeks
The second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Hangzhou, China
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)
Time frame: from informed consent form signature to the end of the study (up to 2 months)
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.
Time frame: 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.
Time frame: 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.
Time frame: from baseline to Day 8; from D28 to D32 (up to 32 days)
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