Telmisartan and Hydrochlorothiazide Antihypertensive Treatment Study in High Sodium Intake Population
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
In this research, the investigators aim to compare the antihypertensive efficacy and safety
of monotherapy of routine dose angiotensin receptor antagonist telmisartan (ARB) and diuretic
Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate hypertension.
The research will be conducted in the rural area in Hebei province, where people have a high
sodium diet in their daily life. The 1200 eligible subjects will be drawn from 12 local
county-level hospitals. Subjects will be randomly allocated in double-blind manner into ARB
or HCTZ group to be administered telmisartan 40mg per day or hydrochlorothiazide 25mg per day
respectively. After two-month treatment, the investigators will evaluate and compare the
antihypertensive efficacy and safety between the two therapies.
The first objective of the research is to compare the antihypertensive efficacy of
monotherapy of routine dose of angiotensin receptor antagonist telmisartan (ARB) and diuretic
Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate
hypertension.The second objective is to compare the safety between the two therapies applied.
Null Hypothesis-H0: There will be no efficacy differences of lowering the systolic pressure
between treating high sodium intake patients with mild to moderate hypertension with
telmisartan and hydrochlorothiazide.Alternative Hypothesis-H1: There will be efficacy
differences of lowering the systolic pressure between treating high sodium intake patients
with mild to moderate hypertension with telmisartan and hydrochlorothiazide.
This research is a multicenter randomized double-blinded parallel controlled trial targeting
on high sodium intake patients with mild to moderate hypertension in China. The eligible 1200
subjects will be randomly divided into ARB and HCTZ two groups, treated with monotherapy of
telmisartan 40mg per day or hydrochlorothiazide 25mg per day respectively. Then, the
compliance of the patients will be followed after a week. The investigators will evaluate the
efficacy of blood pressure control and the safety of the medicines after one month and two
months of the beginning of therapies. Figure 1 shows the research process.