This is a multicenter, randomized, double-blind, controlled clinical trial. It aims to
investigate the effects of different doses of folic acid on lowering homocysteine (Hcy) in
patients with hypertension with different genotypes of MTHFR C677T and to determine a
dose-response relationship.
This study consists of 3 phases: screening ( 2-10 days ), run-in period (0-2 weeks), and
double-blind treatment (8 weeks). Follow-up visits will take place at the beginning of both
the run-in period and the double-blind treatment period, and at the end of the 2nd, 4th, 6th,
and 8th weeks. Hypertensive patients demonstrating good tolerance and adherence to
angiotensin converting enzyme inhibitor (ACEI) drugs and who have already been genotyped for
MTHFR C677T polymorphism may pass over the run-in period and directly enter the double-blind
randomized treatment period. No medications that could affect the assessment of efficacy may
be taken during any stage of the study.
Phase:
Phase 4
Details
Lead Sponsor:
Shenzhen Ausa Pharmed Co.,Ltd
Collaborators:
Anqing Research Center of Anhui Medical University Biomedical Institute Nanfang Hospital of Southern Medical University Peking University First Hospital People's Hospital of Rongcheng Second Affiliated Hospital of Nanchang University Shenzhen Evergreen Medical Institute The First People's Hospital of Lianyungang
Treatments:
Enalapril Enalaprilat Folic Acid Maleic acid Vitamin B Complex