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China Stroke Primary Prevention Trial 2 for Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT)
Sponsor: Shenzhen Ausa Pharmed Co.,Ltd
Summary
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.
Official title: Comparative Efficacy of Amlodipine Folic Acid vs. Amlodipine on the Risk of First Ischemic Stroke Among Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype: A Multi-center, Randomized, Double-blind, Double-dummy, Controlled Clinical Trial
Key Details
Gender
All
Age Range
45 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
32000
Start Date
2024-08-22
Completion Date
2030-06-30
Last Updated
2025-02-26
Healthy Volunteers
No
Conditions
Interventions
Amlodipine besylate
The amlodipine used in this study is a listed product. Amlodipine tablets and amlodipine folic acid (dummy) are provided in aluminum-plastic blisters packaging. Each package includes 100 days of treatment drug (including 10 extra days of treatment for the follow-up window). A package of medication consists of 20 plates, each plate includes a total of 10 tablets arranged as follows: amlodipine 5mg/tablet x5 tablets + amlodipine-folic acid (dummy) x5 tablets. Affixed to the medication package is the randomized treatment drug label (200 tablets/package, 2 tablets/day).
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. Amlodipine-folic acid tablets and amlodipine (dummy) are provided in aluminum-plastic blisters packaging. Each package includes 100 days of treatment drug (including 10 extra days of treatment for the follow-up window). A package of medication consists of 20 plates, each plate includes a total of 10 tablets arranged as follows: amlodipine-folic acid 5.8mg x5 tablets + amlodipine (dummy) x5 tablets. Affixed to the medication package is the randomized treatment drug label (200 tablets/package, 2 tablets/day).
Amlodipine placebos
An amlodipine placebo is a dummy pill of an amlodipine tablet with an identical appearance.
Amlodipine-folic acid placebos
An Amlodipine folic acid placebo is a dummy pill of an amlodipine folic acid tablet with an identical appearance.
Locations (20)
First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Bozhou
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