Effects of Angiotensin II Receptor Blocker Compared With Diuretics in High-risk Hypertensive Patients

Essential Hypertension Clinical Trial

— CHIEF  

Official title:

Phase 4 Study of Effects of ARB Compared With Diuretics in Hypertension Patients With High Cardiovascular Risks

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01011660
• Other study ID #: 115
• Status: Recruiting
• Phase: Phase 4
• First received: November 10, 2009
• Last updated: August 9, 2012
• Start date: October 2007
• Est. completion date: December 2012

Study information

• Verified date: August 2012
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13542
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Amlodipine, Telmisartan, Amiloride Compound , Simvastatin
Amlodipine; Telmisartan; Amiloride Compound; Simvastatin

Locations

Country	Name	City	State
China	Wang Wen	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death.		3-4 years	Yes
Secondary	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		3-4 years	Yes