Prospective a multicenter, open-label, parallel group comparative, trial to evaluate the antihypertensive efficacy and safety of Sacubitril/Valsartan and Amlodipine besylate in patients with essential hypertension (PARASOL study)

未提供0 个研究点目标入组 350 人开始时间: 2023年2月27日最近更新: 2025年1月31日

试验速览

暂无简介。

•(1)Patients at the age of 18 to 79 at the time of obtaining consent.
•(2)Patients with essential hypertension who are 150-179 mmHg on office systolic blood pressure.
•(3)Patients who have not taken antihypertensives for 28 days or more before enrollment.
•(4)Subjects of Wrist blood pressure monitors:Patients with a wrist circumference of 13.5-21.5 cm.

•(1)Patients who are 110 mmHg or higher on office diastolic blood pressure.
•(2)Patients who cannot go to hospital by themselves.
•(3)Female patiens who are breastfeeding, pregnant or who may become pregnant.
•(4)Patients with a history of angioedema (whether drug-related or not).
•(5)Patients with moderate or higher liver dysfunction (Child-Pugh classification B or higher).
•(6)Patients with a history of sensitivity to dihydropyridine.
•(7)Patients with a diagnosis or history of secondary hypertension (Renal Parenchymal Hypertension, Renovascular Hypertension (unilateral or bilateral renal artery stenosis), Coarctation of the aorta, Primary Aldosteronism, Cushing disease, Pheochromocytoma, Polycystic kidney disease, and Drug-Induced Hypertension, etc.).
•(8)Patients with renal disease with eGFR less than 30 diagnosed as G3a or higher in CKD severity classification.
•(9)Patients with a diagnosis or history of stroke (including lacunar infarction).
•(10)Patients with a serum potassium level of 5.5 mmol/L or higher.
•(11)Patients with a diagnosis of white coat hypertension.
•(12)Patients who are working night shifts.
•(13)Patients with an arm circumference greater than 38 cm.
•(14)Patients who are judged by the investigator or subinvestigators to be not suitable for participation in the study due to various other reasons.

Blood pressure change in 24-hour SBP from baseline to Week 8.

Blood pressure change in 24-hour SBP(baseline to Week 8)
Blood pressure change in 24-hour PP(baseline to Week 8)
Achievement rate of antihypertensive target(8 Weeks of administration)
Blood pressure change in 24-hour DBP(baseline to Week 8)
Blood pressure change in 24-hour SBP/DBP on early morning/daytime/nighttime(baseline to Week 8)
Blood pressure change in office blood pressure (SBP, DBP)(baseline to Week 8)
Blood pressure change in nighttime using a Wrist blood pressure monitor(baseline to Week 8)
ABPM and Wrist blood pressure monitor, comparison of blood pressure values
Number of adverse events and their frequency
Blood pressure change in office blood pressure (SBP, DBP) at Week 4(baseline to Week 4)

发起方

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