Clinical trial NCT04974151: China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype
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
Conditions: Hypertension
MTHFR 677 TT Genotype
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.
Interventions:
description: The amlodipine used in this study is a listed product.
name: Amlodipine besylate
other_name: Amlodipine
type: Drug
description: The amlodipine besylate and folic acid tablets have been approved for listing by the China Food and Drug Administration, approval number: Zhunzi H20180020.
name: Amlodipine besylate And Folic Acid
other_name: Amlodipine Folic Acid
Anye
type: Drug
description: The 5-MTHF used in this study is a listed product.
name: 5-methyltetrahydrofolate (5-MTHF)
other_name: 5-MTHF
type: Drug
description: Amlodipine placebos are dummy pills of amlodipine with identical appearance.
name: Amlodipine placebo
other_name: Amlodipine (dummy)
type: Drug
description: Amlodipine folic acid placebos are dummy pills of amlodipine folic acid with identical appearance.
name: Amlodipine folic acid placebo
other_name: Amlodipine folic acid (dummy)
type: Drug
description: 5-MTHF placebos are the dummy pills of 5-MTHF with identical appearance.
name: 5-MTHF Placebos
other_name: 5-MTHF (dummy)
type: Drug
Study arms:
design_group_description: Amlodipine 5mg x1 tablet + Amlodipine folic acid (dummy) x1 tablet + 5-MTHF (dummy) x2 tablets, taken orally, in the morning after waking up.<br/>Amlodipine tablets, amlodipine folic acid placebos, and 5-MTHF placebos are provided in aluminum-plastic blister plate. 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 50 plates, each plate includes a total of 8 tablets arranged as follows: amlodipine 5mg x2 tablets + amlodipine folic acid (dummy) x2 tablets + 5-MTHF (dummy) x4 tablets. Affixed to the package is the randomized treatment drug label (400 tablets/package, 4 tablets/day).
design_group_title: Amlodipine (5mg/d)
design_group_type: Active Comparator
design_group_description: Amlodipine folic acid 5.8mg x1 tablet + amlodipine (dummy) x1 tablet + 5-MTHF (dummy) x2 tablets, taken orally, in the morning after waking up.<br/>Amlodipine folic acid tablets, amlodipine placebos, and 5-MTHF placebos are provided in aluminum-plastic blister plate. 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 50 plates, each plate includes a total of 8 tablets arranged as follows: amlodipine folic acid 5.8mg x2 tablets + amlodipine (dummy) x2 tablets + 5-MTHF (dummy) x4 tablets. Affixed to the package is the randomized treatment drug label (400 tablets/package, 4 tablets/day).
design_group_title: Amlodipine folic acid (5.8mg/d)
design_group_type: Experimental
design_group_description: Amlodipine folic acid 5.8mg x1 tablet + 5-methyltetrahydrofolate 0.2mg x2 tablets + amlodipine (dummy) x1 tablet, taken orally, in the morning after waking up.<br/>Amlodipine folic acid tablets, 5-MTHF, and amlodipine placebos are provided in aluminum-plastic blister plate. 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 50 plates, each plate includes a total of 8 tablets arranged as follows: amlodipine folic acid 5.8mg x2 tablets + amlodipine (dummy) x2 tablets + 5-MTHF, 0.2mg x4 tablets. Affixed to the package is the randomized treatment drug label (400 tablets/package, 4 tablets/day).
design_group_title: Amlodipine folic acid (5.8mg/d) + 5-MTHF (0.4mg/d)
design_group_type: Experimental
Sponsor: Shenzhen Ausa Pharmed Co. Ltd.
Collaborators: The Affiliated Hospital of Guizhou Medical University
Weinan Central Hospital
Shenzhen Prospective Medical Technology Co., Ltd.
Yangjiang Peoples Hospital
The First People's Hospital of Lianyungang
The Second Affiliated Hospital of Nanchang University
Peking University First Hospital
Loudi Central Hospital
Drug name mappings:
name: 左甲柳叶酸钙
lang: CN
name: Levomefolate calcium
lang: EN