Status:
COMPLETED
China Stroke Primary Prevention Trial
Lead Sponsor:
Shenzhen Ausa Pharmed Co.,Ltd
Collaborating Sponsors:
Anhui Medical University
Conditions:
Primary Hypertension
Eligibility:
All Genders
45-75 years
Phase:
PHASE4
Brief Summary
The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more effective in preventing stroke among the patients with primary hypertension when compared to enalapril mal...
Detailed Description
Primary hypertension is the most important risk factor leading to cardiovascular events. Successful management of hypertension is a key to prevent these events. Hyperhomocysteinemia (HHcy) is another ...
Eligibility Criteria
Inclusion
- BP≥140/90 mmHg in both of the two screening visits or currently under anti-hypertension treatment
- 45 - 75 years old
- Successful determination of MTHFR C677T genotype
- For pre-menopausal women, agreed to use contraceptives during the trial
- Signed the written informed consent
Exclusion
- Having a history of stroke
- Having a history of myocardial infarction
- Having a history of physician diagnosed heart failure
- Post- coronary revascularization
- Severe somatic disease such as cancer
- Secondary hypertension
- Congenital or acquired organic heart diseases
- Contraindicated to angiotensin-converting enzyme inhibitor(ACEI)
- History of ACEI adverse effects
- Currently long-term use of folic acid or vitamin B12 or vitamin B6
- Pregnant or child breastfeeding women
- Severe mental disorders
- Lab tests indicating abnormal liver or kidney function
- Unwilling to participate the trial, unwilling to change the current antihypertensive treatment
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
20702 Patients enrolled
Trial Details
Trial ID
NCT00794885
Start Date
May 1 2008
End Date
June 1 2014
Last Update
August 12 2014
Active Locations (2)
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1
Anqing Branch, Anhui Institute of Biomedical Research
Anqing, Anhui, China, 246000
2
Lianyungang Center for Advanced Research in Cardiovascular Diseases
Lianyungang, Jiangsu, China, 222003