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Taking people in ChinaPhase 4

Tests amlodipine with folic acid to prevent a first stroke in hypertension

Tests amlodipine with folic acid in adults with high blood pressure and a gene variant.

Key facts

Who runs it
Shenzhen Ausa Pharmed Co.,Ltd
Where
Beijing, Bengbu, Bozhou, Chengdu, Chizhou, Deyang, Fuyang, Ganzhou, Guiyang, Huaihua, Lianyungang, Loudi, Luzhou, Nanchang, Weinan, Yancheng, Yangjiang, and Zaozhuang, ChinaSee the 20 sites
Trial code
Registry title
China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype
Status
Recruiting
Phase
Phase 4
People taking part
24,000 people, planned
Started
22 Aug 2024
Expected to end
30 Jun 2029
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Amlodipine besylate
  • Amlodipine besylate And Folic Acid
  • 5-methyltetrahydrofolate (5-MTHF)
  • Amlodipine placebo
  • Amlodipine folic acid placebo
  • 5-MTHF Placebos
Record updated
26 February 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men and women aged 45 to under 75 with high blood pressure and the MTHFR 677 TT gene type, to compare treatments for preventing a first stroke.

Age
From 45 up to under 75 years
Sex
Men and women
Disease stage
High blood pressure (primary hypertension): either already treated with blood pressure medicine in the past two weeks, or blood pressure of 140/90 mmHg or higher at two visits on different days
Earlier treatment
No regular folic acid or vitamin B compounds in the past 3 months. No past serious bad reaction to amlodipine, other CCBs, valsartan or other ARBs, indapamide or similar diuretics, metoprolol or other beta-blockers, or any folate or folic acid product.
Biomarker or test result
MTHFR 677 TT genotype, shown by a central lab test during screening or a previous official lab report

Main reasons for not taking part

  • Past stroke, heart attack, heart failure or atrial fibrillation
  • Secondary hypertension
  • On dialysis, or stage 4-5 chronic kidney disease, or eGFR below 30 mL/min/1.73m²
  • Cancer or other severe disease, or vitamin B12 deficiency
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • Men and women, aged ≥45 and <75 years
  • 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
  • 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)
  • Voluntarily participates and has given signed informed consent; Randomized-treatment phase inclusion criteria:
  • Good compliance during the run-in period, and unlikely to discontinue treatment
  • No stroke or cardiovascular events during the run-in period
  • The participant voluntarily agrees to continue the study

Who cannot take part

  • Previously diagnosed secondary hypertension
  • Previously diagnosed stroke
  • Previously diagnosed myocardial infarction
  • Previously diagnosed heart failure
  • Previously diagnosed atrial fibrillation
  • 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
  • Refusal to participate, or inability to modify current drug regimen
  • 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.)
  • Known to have congenital (such as aortic stenosis) or acquired organic heart disease
  • The presence of any of the following conditions that could negatively influence a participant's ability to consent or participate in the trial:; Dementia; Severe mental disorders; Inability to express informed consent; 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; History of poor compliance when taking antihypertensive medications or is expected to have poor compliance during the study
  • Currently on dialysis, or diagnosed with stage 4-5 chronic kidney disease, or eGFR <30 mL/ min/1.73m²
  • Known to have any of the following severe diseases or conditions:; 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; Respiratory system: previously diagnosed with pulmonary heart disease; Presence of malignant tumors or other severe diseases; Presence of long-term gastrointestinal symptoms such as ; anorexia, decreased appetite, nausea, and abdominal bloating; Previously diagnosed with vitamin B12 deficiency and/or its related diseases
  • 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
  • Cardio-cerebral-kidney revascularization and/or other large arterial stent
  • Regular consumption of folic acid or vitamin B compounds, or other compounds containing folic acid in the past 3 months
  • Women who are pregnant or breastfeeding; or subjects of childbearing potential who are unwilling or unable to use effective contraception during the study period

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 45 and 74 years old?

Where in China

  • Peking University First HospitalBeijing, ChinaContact: Jianping Li, MD, PhDNot yet recruiting
  • First Affillated Hospital of Bengbu Medical UniversityBengbu, ChinaContact: Hongju Wang, MDNot yet recruiting
  • Bozhou People's HospitalBozhou, ChinaContact: Rongyan JiangNot yet recruiting
  • Chengdu Fifth People's HospitalChengdu, ChinaContact: Lihua Zhou, MDNot yet recruiting
  • Chizhou People's HospitalChizhou, ChinaContact: Xiaodong Xu, MDNot yet recruiting
  • Deyang People's HospitalDeyang, ChinaContact: Yangyun Han, MDNot yet recruiting
  • Taihe County People's HospitalFuyang, ChinaContact: Shuguang Zhao, MDNot yet recruiting
  • The First Affiliated Hospital of Gannan Medical UniversityGanzhou, ChinaContact: Guoxi Zhang, MDNot yet recruiting
  • The Affiliated Hospital of Guizhou Medical UniversityGuiyang, ChinaContact: Fang WeiNot yet recruiting
  • The First Affiliated Hospital of Hunan University of MedicineHuaihua, ChinaContact: Bifeng TanNot yet recruiting
  • Lianyungang Oriental HospitalLianyungang, ChinaContact: Yubao Wang, MDTaking people
  • The First People's Hospital of LianyungangLianyungang, ChinaContact: Hui Shi, MDNot yet recruiting
  • The Second People's Hospital of LianyungangLianyungang, ChinaContact: Liming Sun, MDNot yet recruiting
  • Loudi Central HospitalLoudi, ChinaContact: Weimin Hu, MDNot yet recruiting
  • The Affiliated Hospital of Southwest Medical UniversityLuzhou, ChinaContact: Juyi WanNot yet recruiting
  • Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaContact: Huihui Bao, MDNot yet recruiting
  • Weinan Central HospitalWeinan, ChinaContact: Junnong Li, MDNot yet recruiting
  • Yancheng First People's HospitalYancheng, ChinaContact: Qilong Zuo, MDNot yet recruiting
  • Yangjiang People's HospitalYangjiang, ChinaContact: Qianqian Tan, MDNot yet recruiting
  • Tengzhou Central People's HospitalZaozhuang, ChinaContact: Yong Li, MDNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • Amlodipine (5mg/d)Existing treatment, for comparison

    Amlodipine 5mg x1 tablet + Amlodipine folic acid (dummy) x1 tablet + 5-MTHF (dummy) x2 tablets, taken orally, in the morning after waking up. Amlodipine tablets, amlodipine folic acid placebos, and 5-MTHF placebos are provided in aluminum-plastic blister plate. 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 50 plates, each plate includes a total of 8 tablets arranged as follows: amlodipine 5mg x2 tablets + amlodipine folic acid (dummy) x2 tablets + 5-MTHF (dummy) x4 tablets. Affixed to the package is the randomized treatment drug label (400 tablets/package, 4 tablets/day).

    Treatment: Amlodipine besylate, Amlodipine folic acid placebo, and 5-MTHF Placebos

  • Amlodipine folic acid (5.8mg/d)Treatment being tested

    Amlodipine folic acid 5.8mg x1 tablet + amlodipine (dummy) x1 tablet + 5-MTHF (dummy) x2 tablets, taken orally, in the morning after waking up. Amlodipine folic acid tablets, amlodipine placebos, and 5-MTHF placebos are provided in aluminum-plastic blister plate. 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 50 plates, each plate includes a total of 8 tablets arranged as follows: amlodipine folic acid 5.8mg x2 tablets + amlodipine (dummy) x2 tablets + 5-MTHF (dummy) x4 tablets. Affixed to the package is the randomized treatment drug label (400 tablets/package, 4 tablets/day).

    Treatment: Amlodipine besylate And Folic Acid, Amlodipine placebo, and 5-MTHF Placebos

  • Amlodipine folic acid (5.8mg/d) + 5-MTHF (0.4mg/d)Treatment being tested

    Amlodipine folic acid 5.8mg x1 tablet + 5-methyltetrahydrofolate 0.2mg x2 tablets + amlodipine (dummy) x1 tablet, taken orally, in the morning after waking up. Amlodipine folic acid tablets, 5-MTHF, and amlodipine placebos are provided in aluminum-plastic blister plate. 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 50 plates, each plate includes a total of 8 tablets arranged as follows: amlodipine folic acid 5.8mg x2 tablets + amlodipine (dummy) x2 tablets + 5-MTHF, 0.2mg x4 tablets. Affixed to the package is the randomized treatment drug label (400 tablets/package, 4 tablets/day).

    Treatment: Amlodipine besylate And Folic Acid, 5-methyltetrahydrofolate (5-MTHF), and Amlodipine placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Tests amlodipine with folic acid to prevent a first stroke in hypertensionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04974151, who can take part
Record updated
26 February 2025