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China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype (CSPPT2-TT)
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.
Details
| Lead sponsor | Shenzhen Ausa Pharmed Co.,Ltd |
|---|---|
| Phase | PHASE4 |
| Status | RECRUITING |
| Enrolment | 24000 |
| Start date | Thu Aug 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sat Jun 30 2029 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Hypertension
- MTHFR 677 TT Genotype
Interventions
- Amlodipine besylate
- Amlodipine besylate And Folic Acid
- 5-methyltetrahydrofolate (5-MTHF)
- Amlodipine placebo
- Amlodipine folic acid placebo
- 5-MTHF Placebos
Countries
China