[Translation] Effect of amlodipine folic acid tablets versus amlodipine tablets on the risk of first ischemic stroke in H-type hypertensive patients with methylenetetrahydrofolate reductase (MTHFR) 677 CC/CT genotype: a multicenter, randomized, double-blind, double-dummy, controlled clinical trial

1、主要目的在MTHFR 677 CC/CT基因型伴高血浆总同型半胱氨酸水平（≥10 μmol/L）和低叶酸水平（<12ng/mL）的高血压参与者中，比较氨氯地平叶酸片（B组）与氨氯地平片（A组）预防首发缺血性脑卒中的疗效是否存在显著差异。 2、次要目的（1）在上述高血压参与者，分别在CC、CT 基因型人群，比较B组和A组间预防首发缺血性脑卒中的疗效是否存在显著差异。（2）在上述高血压参与者，分别在CC或CT 基因型人群、CC和CT 基因型人群比较B组和A组间预防首发脑卒中、心脑血管复合终点、肾脏终点的疗效是否存在显著差异。（3）在上述高血压参与者中，比较B组和A组间预防首发出血性脑卒中、首发心肌梗塞、首发冠状动脉血运重建术、心脑血管死亡的疗效是否存在显著差异。 3、其他目的（1）在上述高血压参与者中，比较B组和A组间预防恶性肿瘤和全因死亡的疗效是否存在显著差异。（2）在上述高血压参与者，分别在CC或CT 基因型人群、CC和CT 基因型人群比较B组和A组间预防血压水平，变异性及降压达标率、血清叶酸水平和变化、血浆总同型半胱氨酸水平和变化的疗效是否存在显著差异。

[Translation]

1. Main purpose Comparison of amlodipine folic acid tablets (B Is there any significant difference in the efficacy of preventing first ischemic stroke between Group A) and amlodipine tablets (Group A)? 2. Secondary purpose (1) Among the above-mentioned hypertensive participants, compare whether there is a significant difference in the efficacy of preventing first ischemic stroke between group B and group A in the CC and CT genotype groups. (2) Among the above-mentioned hypertensive participants, compare the efficacy of group B and group A in preventing first stroke, cardiovascular and cerebrovascular composite endpoints, and renal endpoints in the CC or CT genotype population, and the CC and CT genotype population respectively. The difference. (3) Among the above-mentioned hypertensive participants, compare whether there are significant differences in the efficacy of preventing first hemorrhagic stroke, first myocardial infarction, first coronary revascularization, and cardiovascular and cerebrovascular death between group B and group A. 3. Other purposes (1) Among the above-mentioned hypertensive participants, compare whether there is a significant difference in the efficacy of preventing malignant tumors and all-cause death between group B and group A. (2) Among the above-mentioned hypertensive participants, compare the preventive blood pressure levels, variability, blood pressure target compliance rate, serum folate levels and changes between group B and group A respectively in the CC or CT genotype population, CC and CT genotype population, Are there significant differences in therapeutic efficacy in plasma total homocysteine levels and changes.

Start Date22 Aug 2024

Sponsor / Collaborator

Shenzhen Osa Pharmaceutical Co., Ltd.

[+1]

CTR20222387 / RecruitingPhase 4

氨氯地平叶酸片与氨氯地平片比较对亚甲基四氢叶酸还原酶（MTHFR）677 TT基因型的高血压患者首发缺血性脑卒中风险的影响：一项多中心、随机、双盲、三模拟、对照临床试验

[Translation] Effect of amlodipine folic acid tablets versus amlodipine tablets on the risk of first ischemic stroke in hypertensive patients with methylenetetrahydrofolate reductase (MTHFR) 677 TT genotype: a multicenter, randomized, double-blind, triple-dummy, controlled clinical trial

1、主要研究目的在MTHFR 677 TT基因型的高血压参与者中，比较氨氯地平叶酸片（B+C组）与氨氯地平片（A组）预防首发缺血性脑卒中的疗效是否存在显著差异。 2、次要研究目的（1）在上述高血压参与者，比较B组vs.A组、C组vs.A组、B组vs.C组预防首发缺血性脑卒中的疗效是否存在显著差异。（2）在上述高血压参与者，比较B+C组vs.A组、B组vs.A组、C组vs.A组、B组vs.C组预防首发脑卒中、心脑血管复合终点、肾脏终点的疗效是否存在显著差异。（3）在上述高血压参与者，比较B+C组vs.A组预防首发出血性脑卒中首发心肌梗塞、首发冠状动脉血运重建术、心脑血管死亡的疗效是否存在显著差异。 3、其他研究目的（1）在上述高血压参与者，比较B+C组vs.A组预防恶性肿瘤和全因死亡的疗效是否存在显著差异。（2）在上述高血压参与者，比较B+C组vs.A组、B组vs.A组、C组vs.A组、B组vs.C组预防血压水平，变异性及降压达标率、血清叶酸水平和变化、血浆总同型半胱氨酸水平和变化的疗效是否存在显著差异。

[Translation]

1. Main research purpose Among hypertensive participants with MTHFR 677 TT genotype, compare whether there is a significant difference in the efficacy of amlodipine folic acid tablets (group B+C) and amlodipine tablets (group A) in preventing first ischemic stroke. 2. Secondary research purpose (1) Among the above-mentioned hypertensive participants, compare whether there is a significant difference in the efficacy of preventing first ischemic stroke between group B vs. group A, group C vs. group A, and group B vs. group C. (2) Among the above-mentioned hypertensive participants, compare group B+C vs. group A, group B vs. group A, group C vs. group A, group B vs. group C in preventing first stroke and cardiovascular and cerebrovascular composite endpoints. , whether there is a significant difference in the efficacy of renal endpoints. (3) In the above-mentioned hypertensive participants, compare group B+C vs. group A in preventing first hemorrhagic stroke. Is there a significant difference in the efficacy of first myocardial infarction, first coronary revascularization, and cardiovascular and cerebrovascular death? 3. Other research purposes (1) Among the above-mentioned hypertensive participants, compare whether there is a significant difference in the efficacy of preventing malignant tumors and all-cause death between group B+C and group A. (2) Among the above-mentioned hypertensive participants, compare the preventive blood pressure levels, variability and blood pressure reduction standards of group B+C vs. group A, group B vs. group A, group C vs. group A, group B vs. group C. rate, serum folate levels and changes, and plasma total homocysteine levels and changes.

Start Date22 Aug 2024

Sponsor / Collaborator

Shenzhen Osa Pharmaceutical Co., Ltd.

[+1]

NCT05169021 / Not yet recruitingPhase 4IIT

Folic Acid and Intensive Antihypertensive Therapy for Cerebrovascular and Cardiovascular Events Prevention Among Patients With Hypertension and Cerebral Small Vascular Diseases (FAITH)----A Multicenter, Randomized, Controlled, Open-label, 2x2 Factorial, Blinded End-point Trial

The primary objectives of this trial are:
Efficacy evaluation of amlodipine folic acid tablets:
To assess the effects of amlodipine folic acid tablets 5.8 mg (5 mg amlodipine + 0.8 mg folic acid)versus amlodipine tablets 5 mg in preventing all-cause stroke in cerebral small vascular disease (CSVD) patients with hypertension and elevated homocysteine (Hcy) level.
Intensive Antihypertensive Therapy:
To assess the effect of intensive antihypertensive therapy (SBP<130 mmHg) versus standard antihypertensive therapy (SBP 130-<140 mmHg) in reducing risk of combined cardio-cerebrovascular events in CSVD patients with hypertension and elevated Hcy level, using two basic anti-hypertensive drugs, amlodipine tablets 5 mg or amlodipine folic acid tablets 5.8 mg.

Start Date31 Dec 2021

Sponsor / Collaborator

Beijing Tiantan Hospital

100 Clinical Results associated with Amlodipine/Folic Acid

100 Translational Medicine associated with Amlodipine/Folic Acid

100 Patents (Medical) associated with Amlodipine/Folic Acid

Literatures (Medical) associated with Amlodipine/Folic Acid

31 Dec 2023·Clinical and Experimental Hypertension

Folic acid enhances the cardiovascular protective effect of amlodipine in renal hypertensive rats with elevated homocysteine

Article

Author: Tong, Xiaohui ; Ma, Zebin ; Lv, Lei ; Liu, Haipeng ; Chen, Guang Liang ; Li, Li

OBJECTIVESTo investigate the actions of amlodipine-folic acid (amlodipine-FA) preparation on hypertension and cardiovascular in renal hypertensive rats with hyperhomocysteinemia (HHcy), so as to provide experimental basis for clinical research of amlodipine folic acid tablets.METHODSRats model of renal hypertension with HHcy were established. The rats were randomly divided into groups of model, amlodipine, folic acid (FA) and amlodipine-FA of various dosages. Normal rats were used as normal control group. Blood pressure, Hcy as well as plasma NO, ET-1 and hemodynamics were assayed. Histological alterations of heart and abdominal aorta were also examined.RESULTSCompared with the normal group, blood pressure, plasma Hcy, and NO of the rats in model group were significantly increased, while the plasma ET-1 was decreased. Compared with the normal group, the animals in the model group had reduced cardiac function, thickened wall of the aorta and narrowed lumen. In FA group and amlodipine group, the rat plasma NO was increased while ET-1 was decreased, the protective effect of amlodipine-FA group on endothelial cells was further enhanced. In amlodipine group, the rat hemodynamics (LVSP, LVEDP and ±dp/dt_max, et al.) and vascular damage were significantly reduced, while in amlodipine-FA group, the heart function were further improved, and myocardial and vascular hypertrophy were significantly reduced.CONCLUSIONSAs compared to amlodipine alone, amlodipine -FA can lower both blood pressure and plasma Hcy, significantly enhancing vascular endothelial function to protect the heart and blood vessel in renal hypertensive rats with HHcy.

100 Deals associated with Amlodipine/Folic Acid

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	B03BB51	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Essential Hypertension	CN	Shenzhen Osa Pharmaceutical Co., Ltd.	17 Dec 2018

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed	Not Applicable	Hyperhomocysteinemia \| Hypertension	351	Amlodipine-FA tablet (amlodipine 5 mg/FA 0.4 mg)	-	Positive	11 Jul 2023
				Amlodipine 5 mg/FA 0.8 mg tablet

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