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HypertensionPhase 4CSPPT2-TTNCT04974151

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

A Phase 4 study testing Amlodipine besylate, Amlodipine besylate And Folic Acid and 5-methyltetrahydrofolate (5-MTHF) in people with Hypertension and MTHFR 677 TT Genotype, run by Shenzhen Ausa Pharmed Co.,Ltd at 20 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 45 to 74 years
Conditions the study is for
Hypertension, MTHFR 677 TT Genotype
What is being tested?
Amlodipine besylate, Amlodipine besylate And Folic Acid and 5-methyltetrahydrofolate (5-MTHF)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24,000 participants
Where
20 sitesChina
Study dates
22 Aug 2024to 30 Jun 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • Previously diagnosed secondary hypertension;
  • Previously diagnosed stroke;
  • Previously diagnosed myocardial infarction;
  • Previously diagnosed heart failure;
  • Previously diagnosed atrial fibrillation;
  • Cardio-cerebral-kidney revascularization and/or other large arterial stent;
Show all 26Show fewer
  • Currently on dialysis, or diagnosed with stage 4-5 chronic kidney disease, or eGFR <30 mL/ min/1.73m²;
  • Known to have congenital (such as aortic stenosis) or acquired organic heart disease;
  • 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;
  • 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;
  • Regular consumption of folic acid or vitamin B compounds, or other compounds containing folic acid in the past 3 months;
  • 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;
  • Refusal to participate, or inability to modify current drug regimen;
  • Women who are pregnant or breastfeeding; or subjects of childbearing potential who are unwilling or unable to use effective contraception during the study period.
  • 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.).

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Minqing Tian, PhD contact

86-18818680849

tianminqing@163.com

20 sites in 1 country

China20 sites, 20 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality

    Jianping Li, MD, PhD

    Jianping Li, MD, PhD

    Not yet recruiting

  • First Affillated Hospital of Bengbu Medical University

    Bengbu, Anhui, 233004

    Hongju Wang, MD, 13955231336, 1649134019@qq.com

    Hongju Wang, MD

    Not yet recruiting

  • Bozhou People's Hospital

    Bozhou, Anhui

    Rongyan Jiang

    Rongyan Jiang, MD

    Not yet recruiting

  • Chengdu Fifth People's Hospital

    Chengdu, Sichuan

    Lihua Zhou, MD

    Lihua Zhou, MD

    Not yet recruiting

  • Chizhou People's Hospital

    Chizhou, Anhui

    Xiaodong Xu, MD

    Xiaodong Xu, MD

    Not yet recruiting

  • Deyang People's Hospital

    Deyang, Sichuan

    Yangyun Han, MD

    Yangyun Han, MD

    Not yet recruiting

  • Taihe County People's Hospital

    Fuyang, Anhui

    Shuguang Zhao, MD

    Shuguang Zhao, MD

    Not yet recruiting

  • The First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi

    Guoxi Zhang, MD

    Guoxi Zhang, MD

    Not yet recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

    Fang Wei

    Wei Li, MD

    Not yet recruiting

  • The First Affiliated Hospital of Hunan University of Medicine

    Huaihua, Hunan

    Bifeng Tan

    Bifeng Tan, MD

    Not yet recruiting

  • Lianyungang Oriental Hospital

    Lianyungang, Jiangsu, 222042

    Yubao Wang, MD, 15261379656, wyb7509@163.com

    Yubao Wang, MD

    Recruiting

  • The First People's Hospital of Lianyungang

    Lianyungang, Jiangsu

    Hui Shi, MD

    Hui Shi, MD

    Not yet recruiting

  • The Second People's Hospital of Lianyungang

    Lianyungang, Jiangsu

    Liming Sun, MD

    Liming Sun, MD

    Not yet recruiting

  • Loudi Central Hospital

    Loudi, Hunan

    Weimin Hu, MD

    Weimin Hu, MD

    Not yet recruiting

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan

    Juyi Wan

    Juyi Wan, MD

    Not yet recruiting

  • Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Huihui Bao, MD

    Huihui Bao, MD

    Not yet recruiting

  • Weinan Central Hospital

    Weinan, Shaanxi

    Junnong Li, MD

    Junnong Li, MD

    Not yet recruiting

  • Yancheng First People's Hospital

    Yancheng, Jiangsu

    Qilong Zuo, MD

    Qilong Zuo, MD

    Not yet recruiting

  • Yangjiang People's Hospital

    Yangjiang, Guangdong

    Qianqian Tan, MD

    Qianqian Tan, MD

    Not yet recruiting

  • Tengzhou Central People's Hospital

    Zaozhuang, Shandong, 277599

    Yong Li, MD, 13563295777, tzlysd123@163.com

    Yong Li, MD

    Not yet recruiting

Other trials in China

About this study

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

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.

Read the detailed description

This study consists of 3 periods: Screening, Run-in, and Randomized treatment.

Period I: Screening (V0)

The purpose of Period I is to obtain informed consent and screen for eligible participants.

After obtaining written informed consent, at the screening visit (V0), participants will complete a face-to-face interview and clinical evaluation and measurements. Their biological samples will be collected for laboratory analyses. Collectively, these information will help to determine eligibility for inclusion in the study.

Period II: Run-in Period (VD)

The purpose of Run-in is to assess participants' compliance for following the amlodipine treatment regimen as well as to observe participants' tolerance to amlodipine, so as to screen out those with poor compliance or intolerance to amlodipine treatment.

The run-in phase lasted 2 to 4 weeks, during which oral administration of Amlodipine tablets (5 mg) was given once daily.

Period III: Randomized Treatment (V1-V21)

This is a 5-year period of randomized, double-blind, triple-dummy, controlled treatment. At each of the research centers, participants who remain eligible for participation in the study will be randomized into 3 treatment groups:

  1. Amlodipine-only (5mg/d) with an amlodipine folic acid placebo and 5-MTHF placebos.
  2. Amlodipine folic acid tablet (5.8mg/d) with amlodipine placebo and 5-MTHF placebo.
  3. Amlodipine folic acid tablets (5.8mg/d) and 5-MTHF (0.4mg/d) with an amlodipine placebo in a 1:1:1 ratio, using the randomization and trial supply management (RTSM) platform.

During the treatment period, other antihypertensive drugs can be added to achieve blood pressure control (BP ≤140/90mmHg), including Valsartan (80mg/d), or/and Indapamide (1.5mg/d), or/and metoprolol tartrate tablets (25mg/d). Participants will be followed up every 3 months during the treatment period, and the treatment drugs will be distributed at each visit.

A total of 24,000 participants will be randomly assigned to one of three treatment groups (Group A n=8,000, Group B n=8,000, Group C n=8,000). Based on published data from CSPPT (Huo et al, JAMA, 2015), the 5-year cumulative incidence of first ischemic stroke in the amlodipine-only group is 3.5%. Assuming the 5-year cumulative incidence of first ischemic stroke in the amlodipine-only group is around 3.5%, this trial has 80% power to detect a 20% difference between group A and group B+C in the observed hazard ratio (HR) for incident ischemic stroke (HR≤0.80), at a two-sided significance level of α=0.05. If instead, the 5-year incidence of ischemic stroke in the amlodipine-only group is 2.5%, this trial has 80% power to detect a 23% difference between the treatment groups (A vs B+C) (HR≤0.77).

There are two planned interim analyses, one at the end of the third year, and another at the end of the fourth year. The O'Brien-Fleming alpha-spending function will be used to define the significance level of each interim analysis to ensure that the final overall two-sided significance level of α=0.05 is met.

Being tested
Amlodipine besylate, Amlodipine besylate And Folic Acid, 5-methyltetrahydrofolate (5-MTHF), Amlodipine placebo, Amlodipine folic acid placebo
Keywords
Folic acid, Homocysteine, MTHFR 677 TT genotype, Randomized controlled trial, Ischemic stroke, 5-MTHF
Medical subject headings
Hypertension, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amlodipine besylateDrug

    Also called Amlodipine

    The amlodipine used in this study is a listed product.

  • Amlodipine besylate And Folic AcidDrug

    Also called Amlodipine Folic Acid, Anye

    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)Drug

    Also called 5-MTHF

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

  • Amlodipine placeboDrug

    Also called Amlodipine (dummy)

    Amlodipine placebos are dummy pills of amlodipine with identical appearance.

  • Amlodipine folic acid placeboDrug

    Also called Amlodipine folic acid (dummy)

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

  • 5-MTHF PlacebosDrug

    Also called 5-MTHF (dummy)

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

Study groups in NCT04974151
Study groupRoleWhat they receive
Amlodipine (5mg/d)Active comparatorAmlodipine 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).
Receives: Drug: Amlodipine besylate; Drug: Amlodipine folic acid placebo; Drug: 5-MTHF Placebos
Amlodipine folic acid (5.8mg/d)ExperimentalAmlodipine 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).
Receives: Drug: Amlodipine besylate And Folic Acid; Drug: Amlodipine placebo; Drug: 5-MTHF Placebos
Amlodipine folic acid (5.8mg/d) + 5-MTHF (0.4mg/d)ExperimentalAmlodipine 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).
Receives: Drug: Amlodipine besylate And Folic Acid; Drug: 5-methyltetrahydrofolate (5-MTHF); Drug: Amlodipine placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First ischemic stroke

    The primary aim of the trial is to determine whether amlodipine folic acid tablets (including Group B and Group C), compared to amlodipine alone (Group A), can further reduce the risk of first ischemic stroke among eligible participants with hypertension and the MTHFR 677 TT genotype.

    Measured: By the end of the fifth year of the study

Secondary outcomes (8)

  1. First ischemic stroke (for refined treatment group comparisons)

    We will examine whether there exist significant differences in efficacy in reducing the risk of first ischemic stroke between the following pairs of treatment groups:

    Group B vs. Group A

    Group C vs. Group A

    Group B vs. Group C

    Measured: By the end of the fifth year of the study

  2. First stroke (ischemic and hemorrhagic)

    We will examine whether there exist significant differences in efficacy in reducing the risk of first stroke between the following pairs of treatment groups:

    Groups B + C vs. Group A

    Group B vs. Group A

    Group C vs. Group A

    Group B vs. Group C

    Measured: By the end of the fifth year from baseline

  3. Composite cardiovascular endpoint (first non-fatal stroke, first non-fatal myocardial infarction, cardiovascular death)

    We will examine whether there exist significant differences in efficacy in reducing the risk of composite cardiovascular endpoint between the following pairs of treatment groups:

    Groups B + C vs. Group A

    Group B vs. Group A

    Group C vs. Group A

    Group B vs. Group C

    Measured: By the end of the fifth year from baseline

  4. Kidney outcomes

    1. The primary kidney outcome is composite kidney outcome, defined as: (1) a decrease in eGFR of 30% or more and to a level of less than 60 mL/min/1.73 m2 if the baseline eGFR is 60 mL/min/1.73 m2 or more, or (2) a decrease in eGFR of 50% or more if the baseline eGFR is less than 60 mL/min/1.73 m2, or (3) end-stage kidney disease (ESKD) (eGFR <15 mL/min/1.73m2 or dialysis or kidney transplantation).
    2. Secondary kidney outcomes: (1) eGFR decline ≥40% from baseline, or end-stage kidney disease; (2) annual rate of relative decline in eGFR; (3) Incidence of proteinuria, or progression of proteinuria.

    We will examine whether there exist significant differences in treatment efficacy on the above kidney endpoints between the following pairs of treatment groups:

    Groups B + C vs. Group A

    Group B vs. Group A

    Group C vs. Group A

    Group B vs. Group C

    Measured: By the end of the fifth year from baseline

  5. First hemorrhagic stroke

    We will examine whether amlodipine folic acid tablets (including Groups B and C), compared to amlodipine alone (Group A), show significantly greater efficacy in preventing first hemorrhagic stroke.

    Measured: By the end of the fifth year from baseline

  6. First myocardial infarction

    We will examine whether amlodipine folic acid tablets (including Groups B and C), compared to amlodipine alone (Group A), show significantly greater efficacy in preventing first myocardial infarction.

    Measured: By the end of the fifth year from baseline

  7. First coronary revascularization (coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI])

    We will examine whether amlodipine folic acid tablets (including Groups B and C), compared to amlodipine alone (Group A), show significantly greater efficacy in preventing first coronary revascularization.

    Measured: By the end of the fifth year from baseline

  8. Cardiovascular death

    We will examine whether amlodipine folic acid tablets (including Groups B and C), compared to amlodipine alone (Group A), show significantly greater efficacy in preventing cardiovascular death.

    Measured: By the end of the fifth year from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2021
  2. Study start22 Aug 2024
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, randomized, controlled, double-blind, triple-dummy clinical trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04974151
Sponsor's protocol ID
CSPPT2-TT_2020
Acronym
CSPPT2-TT
Status last verified
Feb 2025
First submitted
13 Jul 2021
Last updated
26 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kjeldsen SE, Julius S, Hedner T, Hansson L. Stroke is more common than myocardial infarction in hypertension: analysis based on 11 major randomized intervention trials. Blood Press. 2001;10(4):190-2. doi: 10.1080/08037050152669684. No abstract available.

    PubMed 11800055

  • Collaboration HLT. Lowering blood homocysteine with folic acid based supplements: meta-analysis of randomised trials. Homocysteine Lowering Trialists' Collaboration. BMJ. 1998 Mar 21;316(7135):894-8.

    PubMed 9569395

  • Homocysteine Lowering Trialists' Collaboration. Dose-dependent effects of folic acid on blood concentrations of homocysteine: a meta-analysis of the randomized trials. Am J Clin Nutr. 2005 Oct;82(4):806-12. doi: 10.1093/ajcn/82.4.806.

    PubMed 16210710

  • Wilcken B, Bamforth F, Li Z, Zhu H, Ritvanen A, Renlund M, Stoll C, Alembik Y, Dott B, Czeizel AE, Gelman-Kohan Z, Scarano G, Bianca S, Ettore G, Tenconi R, Bellato S, Scala I, Mutchinick OM, Lopez MA, de Walle H, Hofstra R, Joutchenko L, Kavteladze L, Bermejo E, Martinez-Frias ML, Gallagher M, Erickson JD, Vollset SE, Mastroiacovo P, Andria G, Botto LD. Geographical and ethnic variation of the 677C>T allele of 5,10 methylenetetrahydrofolate reductase (MTHFR): findings from over 7000 newborns from 16 areas world wide. J Med Genet. 2003 Aug;40(8):619-25. doi: 10.1136/jmg.40.8.619. No abstract available.

    PubMed 12920077

  • Xu X, Li J, Sheng W, Liu L. Meta-analysis of genetic studies from journals published in China of ischemic stroke in the Han Chinese population. Cerebrovasc Dis. 2008;26(1):48-62. doi: 10.1159/000135653. Epub 2008 May 30.

    PubMed 18511872

  • Qin X, Li J, Cui Y, Liu Z, Zhao Z, Ge J, Guan D, Hu J, Wang Y, Zhang F, Xu X, Wang X, Xu X, Huo Y. MTHFR C677T and MTR A2756G polymorphisms and the homocysteine lowering efficacy of different doses of folic acid in hypertensive Chinese adults. Nutr J. 2012 Jan 10;11:2. doi: 10.1186/1475-2891-11-2.

    PubMed 22230384

  • Qin X, Li J, Cui Y, Liu Z, Zhao Z, Ge J, Guan D, Hu J, Wang Y, Zhang F, Xu X, Wang X, Xu X, Huo Y. Effect of folic acid intervention on the change of serum folate level in hypertensive Chinese adults: do methylenetetrahydrofolate reductase and methionine synthase gene polymorphisms affect therapeutic responses? Pharmacogenet Genomics. 2012 Jun;22(6):421-8. doi: 10.1097/FPC.0b013e32834ac5e8.

    PubMed 21869730

  • Qin X, Li J, Zhang Y, Ma W, Fan F, Wang B, Xing H, Tang G, Wang X, Xu X, Xu X, Huo Y. Prevalence and associated factors of diabetes and impaired fasting glucose in Chinese hypertensive adults aged 45 to 75 years. PLoS One. 2012;7(8):e42538. doi: 10.1371/journal.pone.0042538. Epub 2012 Aug 3.

    PubMed 22880024

  • Dong Q, Tang G, He M, Cai Y, Cai Y, Xing H, Sun L, Li J, Zhang Y, Fan F, Wang B, Sun N, Liu L, Xu X, Hou F, Shen H, Xu X, Huo Y. Methylenetetrahydrofolate reductase C677T polymorphism is associated with estimated glomerular filtration rate in hypertensive Chinese males. BMC Med Genet. 2012 Aug 16;13:74. doi: 10.1186/1471-2350-13-74.

    PubMed 22897803

  • Huo Y, Li J, Qin X, Huang Y, Wang X, Gottesman RF, Tang G, Wang B, Chen D, He M, Fu J, Cai Y, Shi X, Zhang Y, Cui Y, Sun N, Li X, Cheng X, Wang J, Yang X, Yang T, Xiao C, Zhao G, Dong Q, Zhu D, Wang X, Ge J, Zhao L, Hu D, Liu L, Hou FF; CSPPT Investigators. Efficacy of folic acid therapy in primary prevention of stroke among adults with hypertension in China: the CSPPT randomized clinical trial. JAMA. 2015 Apr 7;313(13):1325-35. doi: 10.1001/jama.2015.2274.

    PubMed 25771069

  • Huang X, Li Y, Li P, Li J, Bao H, Zhang Y, Wang B, Sun N, Wang J, He M, Yin D, Tang G, Chen Y, Cui Y, Huang Y, Hou FF, Qin X, Huo Y, Cheng X. Association between percent decline in serum total homocysteine and risk of first stroke. Neurology. 2017 Nov 14;89(20):2101-2107. doi: 10.1212/WNL.0000000000004648. Epub 2017 Oct 13.

    PubMed 29030456

  • Qin X, Li Y, Sun N, Wang H, Zhang Y, Wang J, Li J, Xu X, Liang M, Nie J, Wang B, Cheng X, Li N, Sun Y, Zhao L, Wang X, Hou FF, Huo Y. Elevated Homocysteine Concentrations Decrease the Antihypertensive Effect of Angiotensin-Converting Enzyme Inhibitors in Hypertensive Patients. Arterioscler Thromb Vasc Biol. 2017 Jan;37(1):166-172. doi: 10.1161/ATVBAHA.116.308515. Epub 2016 Nov 10.

    PubMed 27834686

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Amlodipine besylate, Amlodipine besylate And Folic Acid and 5-methyltetrahydrofolate (5-MTHF) in people with Hypertension and MTHFR 677 TT Genotype, run by Shenzhen Ausa Pharmed Co.,Ltd at 20 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Minqing Tian, PhD (86-18818680849, tianminqing@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First ischemic stroke (time frame: By the end of the fifth year of the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04974151, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.

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