Home
Clinical Trials
NCT01011660

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

NCT ID: NCT01011660

Last Updated: 2012-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

13542 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Essential Hypertension

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hypertension cardiovascular risk factors drugs intervention lipid-lowering therapy 50-79 years of age sign the informed consent forms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A,1,IV

A means active; 1 means Amlodipine+Amiloride Compound; IV means phase IV

Group Type ACTIVE_COMPARATOR

Amlodipine, Telmisartan, Amiloride Compound , Simvastatin

Intervention Type DRUG

Amlodipine; Telmisartan; Amiloride Compound; Simvastatin

A,2,IV

A means active; 2 means Amlodipine+Telmisartan; IV means phase IV

Group Type ACTIVE_COMPARATOR

Amlodipine, Telmisartan, Amiloride Compound , Simvastatin

Intervention Type DRUG

Amlodipine; Telmisartan; Amiloride Compound; Simvastatin

A,3,IV

A means active; 3 means Amlodipine+Amiloride Compound with or no Simvastatin; IV means phase IV

Group Type ACTIVE_COMPARATOR

Amlodipine, Telmisartan, Amiloride Compound , Simvastatin

Intervention Type DRUG

Amlodipine; Telmisartan; Amiloride Compound; Simvastatin

A,4,IV

A means active; 4 means Amlodipine+Telmisartan with or no Simvastatin; IV means phase IV

Group Type ACTIVE_COMPARATOR

Amlodipine, Telmisartan, Amiloride Compound , Simvastatin

Intervention Type DRUG

Amlodipine; Telmisartan; Amiloride Compound; Simvastatin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Amlodipine, Telmisartan, Amiloride Compound , Simvastatin

Amlodipine; Telmisartan; Amiloride Compound; Simvastatin

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CHIEF

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ma Liyuan

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wen Wang, Professor

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wang Wen

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Liyuan Ma

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 22329591 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

115

Identifier Type: -

Identifier Source: org_study_id