Clinical trial NCT02255253: Telmisartan and Hydrochlorothiazide Antihypertensive Treatment Study in High Sodium Intake Population
Official title: Efficacy of Telmisartan 40mg and Hydrochlorothiazide 25mg Monotherapy in High Sodium Intake Patients With Mild to Moderate Hypertension: a Multicenter Randomized Double-blinded Parallel Controlled Trial
Conditions: Hypertension
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.
Interventions:
description: capsule,40mg per day,2 months
name: Telmisartan
other_name: China Resources Double-crane Pharmaceutical Co., Ltd
type: Drug
description: tablet, 25mg per day, 2 months
name: Hydrochlorothiazide
other_name: Tianjin LiSheng Pharmaceutical Co., Ltd
type: Drug
Study arms:
design_group_description: capsule,40mg per day,2 months
design_group_title: Telmisartan
design_group_type: Experimental
design_group_description: tablet, 25mg per day, 2 months
design_group_title: Hydrochlorothiazide
design_group_type: Experimental
Sponsor: The George Institute for Global Health
Collaborators: Peking University People's Hospital
Drug name mappings:
name: 氢氯噻嗪
lang: CN
name: Hydrochlorothiazide
lang: EN
name: 替米沙坦
lang: CN
name: Telmisartan
lang: EN
name: テルミサルタン
lang: JP