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Phase 4 Study of Effects of ARB Compared With Diuretics in Hypertension Patients With High Cardiovascular Risks


Phase 4
50 Years
79 Years
Open (Enrolling)
Both
Essential Hypertension

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Trial Information

Phase 4 Study of Effects of ARB Compared With Diuretics in Hypertension Patients With High Cardiovascular Risks


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3-4 years

Safety Issue:

Yes

Principal Investigator

Wen Wang, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese Academy of Medical Sciences

Authority:

United States: Food and Drug Administration

Study ID:

115

NCT ID:

NCT01011660

Start Date:

October 2007

Completion Date:

December 2012

Related Keywords:

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

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Location