- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01011660
Effects of Angiotensin II Receptor Blocker Compared With Diuretics in High-risk Hypertensive Patients (CHIEF)
August 9, 2012 updated by: Ma Liyuan, Chinese Academy of Medical Sciences, Fuwai Hospital
Phase 4 Study of Effects of ARB Compared With Diuretics in Hypertension Patients With High Cardiovascular Risks
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
13542
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100037
- Recruiting
- Wang Wen
-
Principal Investigator:
- Wen Wang
-
Contact:
- Liyuan Ma
- Phone Number: 86 10 68335002
- Email: maliyuan600@vip.sina.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
48 years to 77 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A,1,IV
A means active; 1 means Amlodipine+Amiloride Compound; IV means phase IV
|
Amlodipine; Telmisartan; Amiloride Compound; Simvastatin
Other Names:
|
Active Comparator: A,2,IV
A means active; 2 means Amlodipine+Telmisartan; IV means phase IV
|
Amlodipine; Telmisartan; Amiloride Compound; Simvastatin
Other Names:
|
Active Comparator: A,3,IV
A means active; 3 means Amlodipine+Amiloride Compound with or no Simvastatin; IV means phase IV
|
Amlodipine; Telmisartan; Amiloride Compound; Simvastatin
Other Names:
|
Active Comparator: A,4,IV
A means active; 4 means Amlodipine+Telmisartan with or no Simvastatin; IV means phase IV
|
Amlodipine; Telmisartan; Amiloride Compound; Simvastatin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death.
Time Frame: 3-4 years
|
3-4 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3-4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wen Wang, Professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Anticipated)
August 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
November 10, 2009
First Submitted That Met QC Criteria
November 10, 2009
First Posted (Estimate)
November 11, 2009
Study Record Updates
Last Update Posted (Estimate)
August 13, 2012
Last Update Submitted That Met QC Criteria
August 9, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Essential Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Antimetabolites
- Natriuretic Agents
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Membrane Transport Modulators
- Diuretics
- Sodium Channel Blockers
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Diuretics, Potassium Sparing
- Acid Sensing Ion Channel Blockers
- Epithelial Sodium Channel Blockers
- Amlodipine
- Simvastatin
- Telmisartan
- Amiloride
Other Study ID Numbers
- 115
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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