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RECRUITING
NCT04974151
PHASE4

China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype

Sponsor: Shenzhen Ausa Pharmed Co.,Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

Amlodipine besylate

The amlodipine used in this study is a listed product.

DRUG

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.

DRUG

5-methyltetrahydrofolate (5-MTHF)

The 5-MTHF used in this study is a listed product.

DRUG

Amlodipine placebo

Amlodipine placebos are dummy pills of amlodipine with identical appearance.

DRUG

Amlodipine folic acid placebo

Amlodipine folic acid placebos are dummy pills of amlodipine folic acid with identical appearance.

DRUG

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