Condition: Hypertension · MTHFR 677 CC or CT Genotype · Elevated Plasma Homocysteine (Hcy≥10µmol/L) · Sponsor: Shenzhen Ausa Pharmed Co.,Ltd
This is a multi-center, randomized, double-blind, double-dummy, controlled clinical trial. This trial will include 32,000 Chinese men and women with hypertension (H-type hypertension), MTHFR 677 CC or CT genotype, elevated plasma total homocysteine (tHcy ≥10µmol/L), and insufficient serum folate levels (\<12ng/mL). The participants will be first stratified by their MTHFR 677 genotype (CC vs. CT), then randomized to one of two treatment groups in a 1:1 ratio. Group A: amlodipine tablet (5mg), taken orally, once daily, serving as active comparator. Group B: amlodipine folic acid 5.8mg tablet (5mg amlodipine and 0.8mg folic acid), taken orally, once daily. The treatment period is five years and primary endpoint is first ischemic stroke.
This description comes directly from the study's public registry record.
Minqing Tian, PhD · 86-18818680849 · tianminqing@163.com
Always discuss trial participation with your own doctor first.
| First Affiliated Hospital of Bengbu Medical University | Bengbu, Anhui, China | Not Yet Recruiting |
| Bozhou | Bozhou, Anhui, China | Not Yet Recruiting |
| Chizhou People's Hospital | Chizhou, Anhui, China | Not Yet Recruiting |
| Taihe County People's Hospital | Fuyang, Anhui, China | Not Yet Recruiting |
| Peking University First Hospital | Beijing, Beijing Municipality, China | Not Yet Recruiting |
| Yangjiang People's Hospital | Yangjiang, Guangdong, China | Not Yet Recruiting |
| The Affiliated Hospital Of Guizhou Medical University | Guiyang, Guizhou, China | Not Yet Recruiting |
| The First Affiliated Hospital of Hunan University of Medicine | Huaihua, Hunan, China | Not Yet Recruiting |
| Loudi Central Hospital | Loudi, Hunan, China | Not Yet Recruiting |
| Lianyungang Oriental Hospital | Lianyungang, Jiangsu, China | Recruiting |
| The First People's Hospital of Lianyungang | Lianyungang, Jiangsu, China | Not Yet Recruiting |
| The Second People's Hospital of Lianyungang | Lianyungang, Jiangsu, China | Not Yet Recruiting |
+ 8 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04974138