China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype
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
Shenzhen Ausa Pharmed Co.,Ltd
24,000 participants
Aug 22, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
The amlodipine used in this study is a listed product.
The amlodipine besylate and folic acid tablets have been approved for listing by the China Food and Drug Administration, approval number: Zhunzi H20180020.
The 5-MTHF used in this study is a listed product.
Amlodipine placebos are dummy pills of amlodipine with identical appearance.
Amlodipine folic acid placebos are dummy pills of amlodipine folic acid with identical appearance.
5-MTHF placebos are the dummy pills of 5-MTHF with identical appearance.
Locations(20)
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NCT04974151