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China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype
Sponsor: Shenzhen Ausa Pharmed Co.,Ltd
Summary
This is a multi-center, randomized, double-blind, triple-dummy, controlled trial in 24,000 Chinese men and women with hypertension and MTHFR 677 TT genotype. The study participants will be randomized to one of the three treatment groups: 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. Group C: amlodipine folic acid 5.8mg tablet plus 5-methyltetrahydrofolate (5-MTHF, 0.4mg), taken orally, once daily. The primary endpoint is first ischemic stroke.
Official title: Comparative Efficacy of Amlodipine Folic Acid vs. Amlodipine on the Risk of First Ischemic Stroke Among Participants With Hypertension and MTHFR 677 TT Genotype: A Multi-center, Randomized, Double-blind, Triple-dummy, Controlled Clinical Trial
Key Details
Gender
All
Age Range
45 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
24000
Start Date
2024-08-22
Completion Date
2029-06-30
Last Updated
2025-02-26
Healthy Volunteers
No
Conditions
Interventions
Amlodipine besylate
The amlodipine used in this study is a listed product.
Amlodipine besylate And Folic Acid
The amlodipine besylate and folic acid tablets have been approved for listing by the China Food and Drug Administration, approval number: Zhunzi H20180020.
5-methyltetrahydrofolate (5-MTHF)
The 5-MTHF used in this study is a listed product.
Amlodipine placebo
Amlodipine placebos are dummy pills of amlodipine with identical appearance.
Amlodipine folic acid placebo
Amlodipine folic acid placebos are dummy pills of amlodipine folic acid with identical appearance.
5-MTHF Placebos
5-MTHF placebos are the dummy pills of 5-MTHF with identical appearance.
Locations (20)
First Affillated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Bozhou People's Hospital
Bozhou, Anhui, China
Chizhou People's Hospital
Chizhou, Anhui, China
Taihe County People's Hospital
Fuyang, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Yangjiang People's Hospital
Yangjiang, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The First Affiliated Hospital of Hunan University of Medicine
Huaihua, Hunan, China
Loudi Central Hospital
Loudi, Hunan, China
Lianyungang Oriental Hospital
Lianyungang, Jiangsu, China
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Yancheng First People's Hospital
Yancheng, Jiangsu, China
The First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Weinan Central Hospital
Weinan, Shaanxi, China
Tengzhou Central People's Hospital
Zaozhuang, Shandong, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, China
Deyang People's Hospital
Deyang, Sichuan, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China