Effects of Angiotensin II Receptor Blocker Compared With Diuretics in High-risk Hypertensive Patients (CHIEF)
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ClinicalTrials.gov Identifier: NCT01011660 |
Recruitment Status
: Unknown
Verified August 2012 by Ma Liyuan, Cardiovascular Institute & Fuwai Hospital.
Recruitment status was: Recruiting
First Posted
: November 11, 2009
Last Update Posted
: August 13, 2012
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Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Information provided by (Responsible Party):
Ma Liyuan, Cardiovascular Institute & Fuwai Hospital
Tracking Information | ||||
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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 |
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 |
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 |
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Condition ICMJE | Essential Hypertension | |||
Intervention ICMJE | Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin
Amlodipine; Telmisartan; Amiloride Compound; Simvastatin
Other Name: CHIEF |
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Study Arms |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |