PARASOL study

JRCT ID: jRCTs051220165

Registered date:07/02/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: essential hypertension
• Date of first enrollment: 27/02/2023
• Target sample size: 350
• Study type: Interventional

Intervention(s)

Test drug administration group:
Sacubitril/Valsartan is administered orally once daily after breakfast for 10 weeks.
Control drug administration group:
Amlodipine besylate is administered orally once daily after breakfast for 10 weeks.

Outcome(s)

• Primary Outcome: Blood pressure change in 24-hour SBP from baseline to Week 8.

Secondary Outcome

(1)Blood pressure change in 24-hour SBP from baseline to Week 8.
(2)Blood pressure change in 24-hour DBP from baseline to Week 8.
(3)Blood pressure change in 24-hour PP from baseline to Week 8.
(4)Blood pressure change in 24-hour SBP/DBP on early morning/daytime/nighttime from baseline to Week 8.
(5)Blood pressure change in office blood pressure (SBP, DBP) from baseline to Week 8.
(6)Achievement rate of antihypertensive target at 8 Weeks of administration.
(7)Blood pressure change in nighttime from baseline to Week 8 using a Wrist blood pressure monitor.
(8)ABPM and Wrist blood pressure monitor, comparison of blood pressure values in each measurement.
(9)Number of adverse events and their frequency.
(10)Blood pressure change in office blood pressure (SBP, DBP) from baseline to Week 4.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

(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.

Exclude criteria

(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.

Related Information

• Primary Sponsor: Yamamoto Koichi
• Secondary Sponsor: Rakugi Hiromi,Novartis Pharma K.K.