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