China Stroke Primary Prevention Trial

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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 maleate.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen Ausa Pharmed Co.,Ltd
• Collaborator: Anhui Medical University
• Treatments: Enalapril; Enalaprilat; Folic Acid; Maleic acid; Vitamin B Complex

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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