Essential HypertensionPhase 4CHIEFNCT01011660
Effects of Angiotensin II Receptor Blocker Compared With Diuretics in High-risk Hypertensive Patients
A Phase 4 study testing Amlodipine, Telmisartan, Amiloride Compound , Simvastatin in people with Essential Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Amlodipine, Telmisartan, Amiloride Compound , Simvastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,542 participants
- Where
- 1 siteChina
- Study dates
- Oct 2007to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- essential hypertension
- 50-79 years old
- with at least one of the cardiovascular risk factor
- sign consent forms
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wang Wen
Beijing, Beijing Municipality, 100037
Liyuan Ma, 86 10 68335002, maliyuan600@vip.sina.com
Wen Wang
About this study
Official title: 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.
Read the detailed description
This study is aimed to observe the main outcome (stroke, myocardial infarction and death from cardiovascular disease) differences between different groups.
- Conditions
- Essential Hypertension
- Being tested
- Amlodipine, Telmisartan, Amiloride Compound , Simvastatin
- Keywords
- hypertension, cardiovascular risk factors, drugs intervention, lipid-lowering therapy, 50-79 years of age, sign, the informed, consent, forms
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine, Telmisartan, Amiloride Compound , SimvastatinDrug
Also called CHIEF
Amlodipine; Telmisartan; Amiloride Compound; Simvastatin
| Study group | Role | What they receive |
|---|---|---|
| A,1,IV | Active comparator | A means active; 1 means Amlodipine+Amiloride Compound; IV means phase IV Receives: Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin |
| A,2,IV | Active comparator | A means active; 2 means Amlodipine+Telmisartan; IV means phase IV Receives: Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin |
| A,3,IV | Active comparator | A means active; 3 means Amlodipine+Amiloride Compound with or no Simvastatin; IV means phase IV Receives: Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin |
| A,4,IV | Active comparator | A means active; 4 means Amlodipine+Telmisartan with or no Simvastatin; IV means phase IV Receives: Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death.
Measured: 3-4 years
Secondary outcomes (1)
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
Measured: 3-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startOct 2007
- Primary completionAug 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 13,542 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Liyuan, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Wen Wang, Professor, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011660
- Sponsor's protocol ID
- 115
- Acronym
- CHIEF
- Status last verified
- Aug 2012
- First submitted
- 10 Nov 2009
- Last updated
- 13 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 22329591
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Effects of ARB Compared With Diuretics in Hypertension Patients With High Cardiovascular Risks
- ClinicalTrials.gov ID
- NCT01011660
- Acronym / sponsor ID
- CHIEF / 115
- Conditions
- Essential Hypertension
- Keywords
- hypertension, cardiovascular risk factors, drugs intervention, lipid-lowering therapy, 50-79 years of age, sign, the informed, consent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13,542 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A,1,IV | Active comparator | Drug: Amlodipine, Telmisartan, Amiloride Compound , SimvastatinA means active; 1 means Amlodipine+Amiloride Compound; IV means phase IV |
| A,2,IV | Active comparator | Drug: Amlodipine, Telmisartan, Amiloride Compound , SimvastatinA means active; 2 means Amlodipine+Telmisartan; IV means phase IV |
| A,3,IV | Active comparator | Drug: Amlodipine, Telmisartan, Amiloride Compound , SimvastatinA means active; 3 means Amlodipine+Amiloride Compound with or no Simvastatin; IV means phase IV |
| A,4,IV | Active comparator | Drug: Amlodipine, Telmisartan, Amiloride Compound , SimvastatinA means active; 4 means Amlodipine+Telmisartan with or no Simvastatin; IV means phase IV |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- essential hypertension
- 50-79 years old
- with at least one of the cardiovascular risk factor
- sign consent forms
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amlodipine, Telmisartan, Amiloride Compound , SimvastatinAlso: CHIEFAmlodipine; Telmisartan; Amiloride Compound; Simvastatin | Drug | A,1,IV, A,2,IV, A,3,IV, A,4,IV |
Primary outcome
The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death.
Time frame: 3-4 years
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2012.
- Derived from this study: PubMed 22329591Ma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Wang, Professor principal investigator
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amlodipine, Telmisartan, Amiloride Compound , Simvastatin in people with Essential Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death. (time frame: 3-4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01011660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2012.