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Clinical Trials in China / NCT04974151
Recruiting Phase 4

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

NCT04974151 · tracked via the Priya Life Science China tracker
Sponsor
Shenzhen Ausa Pharmed Co.,Ltd
Phase
Phase 4
Started
2024-08-22
Last updated
2025-02-26

Condition(s) studied

HypertensionMTHFR 677 TT Genotype

Investigational drug(s) / intervention(s)

Amlodipine besylate →Amlodipine besylate And Folic Acid5-methyltetrahydrofolate (5-MTHF)Amlodipine placeboAmlodipine folic acid placebo5-MTHF Placebos

Amlodipine besylate: The amlodipine used in this study is a listed product.

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.

5-methyltetrahydrofolate (5-MTHF): The 5-MTHF used in this study is a listed product.

Amlodipine placebo: Amlodipine placebos are dummy pills of amlodipine with identical appearance.

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

5-MTHF Placebos: 5-MTHF placebos are the dummy pills of 5-MTHF with identical appearance.

Study 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

Sex
ALL
Min age
45 Years
Max age
74 Years
Healthy volunteers
No
Inclusion Criteria: 1. Men and women, aged ≥45 and \<75 years. 2. Hypertension: Previously diagnosed with primary hypertension and has been taking antihypertensive medication within the past two weeks; OR has not been taking antihypertensive medications within the last two weeks, but meets the following criteria for hypertension: SBP≥140 mmHg and/or DBP≥90 mmHg (average of at least 2 measurements each time) at two separate (not on the same day) clinical visits. 3. MTHFR 677 TT genotype (based on the test results from the central laboratory during the screening period or a previous official test report from a laboratory with medical testing qualifications). 4. Voluntarily participates and has given signed informed consent. Randomized-treatment phase inclusion criteria: 1. Good compliance during the run-in period, and unlikely to discontinue treatment; 2. No stroke or cardiovascular events during the run-in period; 3. The participant voluntarily agrees to continue the study. Exclusion Criteria: 1. Previously diagnosed secondary hypertension; 2. Previously diagnosed stroke; 3. Previously diagnosed myocardial infarction; 4. Previously diagnosed heart failure; 5. Previously diagnosed atrial fibrillation; 6. Cardio-cerebral-kidney revascularization and/or other large arterial stent; 7. Currently on dialysis, or diagnosed with stage 4-5 chronic kidney disease, or eGFR \<30 mL/ min/1.73m²; 8. Known to have congenital (such as aortic stenosis) or acquired organic heart disease; 9. Known to have any of the following severe diseases or conditions: 1. Digestive system: i. Previously diagnosed with any form of viral hepatitis that is currently still in the active phase; ii. Abnormal liver function test before enrollment (any of ALT, AST, GGT, TBIL, DBIL test 3 times higher than normal, or ALB≤30g/L); iii. Subtotal gastrectomy and/or gastrojejunostomy; 2. Respiratory system: previously diagnosed with pulmonary heart disease; 3. Presence of malignant tumors or other severe diseases; 4. Presence of long-term gastrointestinal symptoms such as ; anorexia, decreased appetite, nausea, and abdominal bloating; 5. Previously diagnosed with vitamin B12 deficiency and/or its related diseases. 10. Participant, at the investigator's discretion, is assessed to be unsuitable for the study, for reasons including but not limited to the presence of abnormal laboratory results, or clinical conditions; 11. Prior history of significant intolerance due to adverse reactions resulting from usage of amlodipine or other CCBs, valsartan or other ARBs, indapamide or other similar diuretics, metoprolol tartaric acid or other beta-blockers, or any drugs or health products containing folate or folic acid; 12. Regular consumption of folic acid or vitamin B compounds, or other compounds containing folic acid in the past 3 months; 13. The presence of any of the following conditions that could negatively influence a participant's ability to consent or participate in the trial: 1. Dementia; 2. Severe mental disorders; 3. Inability to express informed consent; 4. Unlikely to complete the study follow-up as specified by the protocol, or plans to relocate outside of the study area in the near future; 5. History of poor compliance when taking antihypertensive medications or is expected to have poor compliance during the study; 14. Refusal to participate, or inability to modify current drug regimen; 15. Women who are pregnant or breastfeeding; or subjects of childbearing potential who are unwilling or unable to use effective contraception during the study period. 16. Within one month prior to the first visit, having participated in any clinical trial for a drug that has not yet been officially approved by the state or is not currently approved for sale; or currently participating in any clinical trial that could potentially impact the results of this study (medication use, drug efficacy, drug interaction, etc.).

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
First Affillated Hospital of Bengbu Medical University Bengbu Anhui Not Yet Recruiting
Bozhou People's Hospital Bozhou Anhui Not Yet Recruiting
Chizhou People's Hospital Chizhou Anhui Not Yet Recruiting
Taihe County People's Hospital Fuyang Anhui Not Yet Recruiting
Peking University First Hospital Beijing Beijing Municipality Not Yet Recruiting
Yangjiang People's Hospital Yangjiang Guangdong Not Yet Recruiting
The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou Not Yet Recruiting
The First Affiliated Hospital of Hunan University of Medicine Huaihua Hunan Not Yet Recruiting
Loudi Central Hospital Loudi Hunan Not Yet Recruiting
Lianyungang Oriental Hospital Lianyungang Jiangsu Recruiting
The First People's Hospital of Lianyungang Lianyungang Jiangsu Not Yet Recruiting
The Second People's Hospital of Lianyungang Lianyungang Jiangsu Not Yet Recruiting
Yancheng First People's Hospital Yancheng Jiangsu Not Yet Recruiting
The First Affiliated Hospital of Gannan Medical University Ganzhou Jiangxi Not Yet Recruiting
Second Affiliated Hospital of Nanchang University Nanchang Jiangxi Not Yet Recruiting
Weinan Central Hospital Weinan Shaanxi Not Yet Recruiting
Tengzhou Central People's Hospital Zaozhuang Shandong Not Yet Recruiting
Chengdu Fifth People's Hospital Chengdu Sichuan Not Yet Recruiting
Deyang People's Hospital Deyang Sichuan Not Yet Recruiting
The Affiliated Hospital of Southwest Medical University Luzhou Sichuan Not Yet Recruiting

More Shenzhen Ausa Pharmed Co.,Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04974151 on ClinicalTrials.gov ↗ ← All trials in China