China Stroke Primary Prevention Trial 2 for Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT)

PHASE4RecruitingINTERVENTIONAL
Enrollment

32,000

Participants

Timeline

Start Date

August 22, 2024

Primary Completion Date

June 30, 2030

Study Completion Date

June 30, 2030

Conditions
HypertensionMTHFR 677 CC or CT GenotypeElevated Plasma Homocysteine (Hcy≥10µmol/L)Insufficient Plasma Folate Levels (<12ng/mL)
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.

Trial Locations (20)

222042

RECRUITING

Lianyungang Oriental Hospital, Lianyungang

233004

NOT_YET_RECRUITING

First Affiliated Hospital of Bengbu Medical University, Bengbu

277599

NOT_YET_RECRUITING

Tengzhou Central People's Hospital, Zaozhuang

Unknown

NOT_YET_RECRUITING

Bozhou, Bozhou

NOT_YET_RECRUITING

Chizhou People's Hospital, Chizhou

NOT_YET_RECRUITING

Taihe County People's Hospital, Fuyang

NOT_YET_RECRUITING

Peking University First Hospital, Beijing

NOT_YET_RECRUITING

Yangjiang People's Hospital, Yangjiang

NOT_YET_RECRUITING

The Affiliated Hospital Of Guizhou Medical University, Guiyang

NOT_YET_RECRUITING

The First Affiliated Hospital of Hunan University of Medicine, Huaihua

NOT_YET_RECRUITING

Loudi Central Hospital, Loudi

NOT_YET_RECRUITING

The First People's Hospital of Lianyungang, Lianyungang

NOT_YET_RECRUITING

The Second People's Hospital of Lianyungang, Lianyungang

NOT_YET_RECRUITING

Yancheng First People's Hospital, Yancheng

NOT_YET_RECRUITING

The First Affiliated Hospital of Gannan Medical University,, Ganzhou

NOT_YET_RECRUITING

Second Affiliated Hospital of Nanchang University, Nanchang

NOT_YET_RECRUITING

Weinan Central Hospital, Weinan

NOT_YET_RECRUITING

Chengdu Fifth People's Hospital, Chengdu

NOT_YET_RECRUITING

Deyang People's Hospital, Deyang

NOT_YET_RECRUITING

The Affiliated Hospital of Southwest Medical University, Luzhou

All Listed Sponsors
collaborator

Peking University First Hospital

OTHER

collaborator

Second Affiliated Hospital of Nanchang University

OTHER

collaborator

The First People's Hospital of Lianyungang

OTHER

collaborator

The Affiliated Hospital Of Guizhou Medical University

OTHER

collaborator

Lianyungang Oriental Hospital

OTHER

collaborator

Tengzhou Central People's Hospital

OTHER_GOV

collaborator

The First Affiliated Hospital of Bengbu Medical University

OTHER

collaborator

Shenzhen Prospective Medical Technology Co., LTD

UNKNOWN

collaborator

Weinan Central Hospital

OTHER

collaborator

The First Affiliated Hospital of HuNan University of Medicine

UNKNOWN

collaborator

Loudi Central Hospital

OTHER

collaborator

Yancheng First People's Hospital

OTHER

collaborator

TAIHE country people's hospital

UNKNOWN

collaborator

First Affiliated Hospital of Gannan Medical University

OTHER

collaborator

Yangjiang People's Hospital

OTHER

collaborator

Deyang People's Hospital

OTHER

collaborator

Bozhou people's hospital

UNKNOWN

collaborator

Lianyungang Second People's Hospital

UNKNOWN

collaborator

The Affiliated Hospital Of Southwest Medical University

OTHER

collaborator

Chengdu Fifth People's Hospital

OTHER

collaborator

Chizhou people's hospital

UNKNOWN

lead

Shenzhen Ausa Pharmed Co.,Ltd

INDUSTRY

NCT04974138 - China Stroke Primary Prevention Trial 2 for Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT) | Biotech Hunter | Biotech Hunter