Clinical trial NCT01011660: Effects of Angiotensin II Receptor Blocker Compared With Diuretics in High-risk Hypertensive Patients
Official title: Phase 4 Study of Effects of ARB Compared With Diuretics in Hypertension Patients With High Cardiovascular Risks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Essential Hypertension
Keywords: hypertension
cardiovascular risk factors
drugs intervention
lipid-lowering therapy
50-79 years of age
sign
the informed
consent
forms
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2009-11-11
Enrollment: 13542
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the optimized treatment strategy of hypertension, so as to make more patients to reach the blood pressure goals and to reduce cardio-cerebrovascular events. Objective and Methods: Patients are eligible for inclusion in the study if they are essential hypertension, 50-79 years of age with at least one cardiovascular risk factor and sign the informed consent forms. This project is a multi-centre, prospective randomized,，openlabel blind-endpoint evaluation controlled (PROBE) trial. 12000 patients will be randomly assigned to either of low-dose Amlodipine+Telmisartan group or Amlodipine+ diuretics group. Among those patients with serum cholesterol between 4.0-6.1mmol/L, they will be also randomized into small dose of statin-based regimen or standard management regimen; Patients will also randomly assigned to intensive lifestyle intervention group or standard intervention group according to the community area where the patients in.

Detailed description: This study is aimed to observe the main outcome (stroke, myocardial infarction and death from cardiovascular disease) differences between different groups.

Eligibility criteria: Inclusion Criteria:

* essential hypertension
* 50-79 years old
* with at least one of the cardiovascular risk factor
* sign consent forms

Exclusion Criteria:

* secondary hypertension
* attack of cerebrovascular events or myocardial infarction within recent 3 months
* coexistence of severe cardiomyopathy, rheumatic or congenital heart diseases
* unstable angina
* severe hepatopathy or nephropathy (ALT elevation \> 2 fold or serum creatinine \> 2.5mg/dl)
* malignant tumor
* gout
* women taking contraceptives or with pregnancy
* allergic history to the research drugs
* validated contradiction to the research drugs
* participating in other clinical trials
* unable for long-term follow-up or poor compliance
* unsuitable for clinical trial at the discretion of doctors in charge

Primary outcomes:
measure: The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death.
timeFrame: 3-4 years
Secondary outcomes:
measure: All cardiovascular events；all-cause death, hospitalization for angina pectoris, coronary revascularization, aortic dissection, cerebrovascular disease, heart failure, renal insufficiency, tumor, new onset of atrial fibrillation and diabetes mellitus
timeFrame: 3-4 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wang Wen
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Wen Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ma L, Wang W, Zhao Y, Zhang Y, Deng Q, Liu M, Sun H, Wang J, Liu L. Combination of amlodipine plus angiotensin receptor blocker or diuretics in high-risk hypertensive patients: a 96-week efficacy and safety study. Am J Cardiovasc Drugs. 2012 Apr 1;12(2):137-42. doi: 10.2165/11598110-000000000-00000.