Telmisartan and Hydrochlorothiazide Antihypertensive Treatment Study in High Sodium Intake Population
NCT ID: NCT02255253
Last Updated: 2015-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1410 participants
INTERVENTIONAL
2014-10-31
2015-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Telmisartan
capsule,40mg per day,2 months
Telmisartan
capsule,40mg per day,2 months
Hydrochlorothiazide
tablet, 25mg per day, 2 months
Hydrochlorothiazide
tablet, 25mg per day, 2 months
Interventions
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Telmisartan
capsule,40mg per day,2 months
Hydrochlorothiazide
tablet, 25mg per day, 2 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Essential hypertension: systolic blood pressure (SBP) is between 140mmHg-179mmHg and diastolic blood pressure (DBP)\<110mmHg OR DBP is between 90mmHg-109mmHg and SBP\<180mmHg.
* Hypertension patients diagnosed by spot urine test (urine sodium≥200mmol/24h).
* Subjects are not using antihypertensive medicines or medicines which affect the blood pressure within a week.
* Subjects volunteer to be brought in the research and have signed informed consent form, given that they have understood the research content.
Exclusion Criteria
* Patients who have seriously allergic reaction or angioneurotic edema when taking ARB; Patients who have allergic history of thiazide diuretic (HCTZ) or sulfonamides.
* Patients who do not want to stop or have to take the medicines which are also antihypertensive or affect the blood pressure, other than which provided by the research.
* Stroke or CHD patients who are diagnosed within 6 months. CHD patients are identified by being diagnosed by coronary arteriography or coronary CT angiography, having received coronary stent or coronary artery bypass surgery, or being diagnosed with acute myocardial infarction. Stroke patients are identified by being diagnosed with cerebral thrombosis, cerebral embolism, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack.
* Patients who are clearly diagnosed with following diseases: Congenital disease, myocardiopathy, serious arrhythmia, pulmonary heart disease, various of cardiac failure.
* Patients who are clearly diagnosed with following symptoms or diseases: Proteinuria or heavy proteinuria, renal insufficiency or serious renal function damage, hepatic insufficiency or serious hepatic function damage; retinal exudates or hemorrhage, or papilledema.
* Patients who are clearly diagnosed with serious or deadly diseases in other systems.
* Patients who get dementia or other serious diseases cannot cooperate with researchers.
* Patients who drink 200g white spirits per day in past week.
* Patients who meet other situations which are considered to be inappropriate to be enrolled into the study by researchers.
18 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
The George Institute for Global Health, China
OTHER
Responsible Party
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Puhong Zhang
Associate Professor
Principal Investigators
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Zhang Pu Hong
Role: PRINCIPAL_INVESTIGATOR
The George Institute
Locations
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Chinese Traditional Medicine Hospital of Anguo
Baoding, Hebei, China
Boye hospital
Baoding, Hebei, China
Lixian chinese traditional medicine hospital
Baoding, Hebei, China
Gaoyang hospital
Baoding, Hebei, China
People's hospital in Rongcheng
Baoding, Hebei, China
Mancheng Hospital
Baoding, Hebei, China
Shunping Hospital
Baoding, Hebei, China
People's hospital of Tangxian
Baoding, Hebei, China
Wangdu hospital
Baoding, Hebei, China
Gaobeidian hospital
Baoding, Hebei, China
Central hospital in Baigou
Baoding, Hebei, China
The second hospital of Lai Shui
Baoding, Hebei, China
Wenan Hospital
Lanfang, Hebei, China
Dacheng chinese traditional medicine hospital
Langfang, Hebei, China
Countries
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References
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Zhang P, Wang H, Sun L, Zhang J, Xi Y, Wu Y, Yan LL, Li X, Sun N. Telmisartan and hydrochlorothiazide antihypertensive treatment in high sodium intake population: a randomized double-blind trial. J Hypertens. 2017 Oct;35(10):2077-2085. doi: 10.1097/HJH.0000000000001407.
Other Identifiers
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2013BAI05B02
Identifier Type: -
Identifier Source: org_study_id
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