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

NCT01011660 | Unknown Phase 4 DMC

• 1 other identifier: 115
• Study Type: interventional
• Target: 13,542
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death.

  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

  3-4 years

Study Arms (4)

A,1,IV

ACTIVE COMPARATOR

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

Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin

A,2,IV

ACTIVE COMPARATOR

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

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

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

Drug: Amlodipine, Telmisartan, Amiloride Compound , Simvastatin

Interventions

Amlodipine, Telmisartan, Amiloride Compound , Simvastatin DRUG

Amlodipine; Telmisartan; Amiloride Compound; Simvastatin

Also known as: CHIEF

A,1,IV; A,2,IV; A,3,IV; A,4,IV

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• essential hypertension
• years old
• with at least one of the cardiovascular risk factor
• sign consent forms

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Wang Wen

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 22329591 DERIVED

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

Amlodipine; Telmisartan; Simvastatin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Wen Wang, Professor

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 11, 2009
• Study Start: October 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 13, 2012

Record last verified: 2012-08

Locations

CN (1)