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

Tracking Information
First Submitted Date ICMJE	November 10, 2009
First Posted Date ICMJE	November 11, 2009
Last Update Posted Date	August 13, 2012
Study Start Date ICMJE	October 2007
Estimated Primary Completion Date	August 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 10, 2009)	The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death. [ Time Frame: 3-4 years ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01011660 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 10, 2009)	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 [ Time Frame: 3-4 years ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effects of Angiotensin II Receptor Blocker Compared With Diuretics in High-risk Hypertensive Patients
Official Title ICMJE	Phase 4 Study of Effects of ARB Compared With Diuretics in Hypertension Patients With High Cardiovascular Risks
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.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Essential Hypertension
Intervention ICMJE	Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin; Amlodipine; Telmisartan; Amiloride Compound; Simvastatin; Other Name: CHIEF
Study Arms	Active Comparator: A,1,IV A means active; 1 means Amlodipine+Amiloride Compound; IV means phase IV Intervention: Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin; Active Comparator: A,2,IV A means active; 2 means Amlodipine+Telmisartan; IV means phase IV Intervention: Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin; Active Comparator: A,3,IV A means active; 3 means Amlodipine+Amiloride Compound with or no Simvastatin; IV means phase IV Intervention: Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin; Active Comparator: A,4,IV A means active; 4 means Amlodipine+Telmisartan with or no Simvastatin; IV means phase IV Intervention: Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: November 10, 2009)	13542
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	December 2012
Estimated Primary Completion Date	August 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	50 Years to 79 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	China
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01011660
Other Study ID Numbers ICMJE	115
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Ma Liyuan, Cardiovascular Institute & Fuwai Hospital
Study Sponsor ICMJE	Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Wen Wang, Professor Chinese Academy of Medical Sciences
PRS Account	Chinese Academy of Medical Sciences, Fuwai Hospital
Verification Date	August 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP