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RECRUITING
NCT04974138
PHASE4

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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).

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. 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).

DRUG

Amlodipine placebos

An amlodipine placebo is a dummy pill of an amlodipine tablet with an identical appearance.

DRUG

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