[Translation] A multicenter, randomized, double-blind phase III clinical trial to evaluate the efficacy and safety of valsartan maleate levamlodipine (SYH9056) tablets in patients with primary mild to moderate hypertension whose blood pressure cannot be effectively controlled after 4 weeks of monotherapy

主要目的：评价SYH9056片用于马来酸左氨氯地平或缬沙坦单药治疗4周后血压不能有效控制的原发性轻、中度高血压患者的有效性。次要目的： 1) 评价SYH9056片用于马来酸左氨氯地平或缬沙坦单药治疗4周后血压不能有效控制的原发性轻、中度高血压患者的12周末和24周末的其他疗效指标的变化； 2) 评价SYH9056片用于马来酸左氨氯地平或缬沙坦单药治疗4周后血压不能有效控制的原发性轻、中度高血压患者的安全性。

[Translation]

Main purpose: To evaluate the effectiveness of SYH9056 tablets in patients with primary mild and moderate hypertension whose blood pressure cannot be effectively controlled after 4 weeks of monotherapy with levamlodipine maleate or valsartan. Secondary purpose: 1) To evaluate the changes of other efficacy indicators of SYH9056 tablets at the end of 12 weeks and 24 weeks in patients with primary mild and moderate hypertension whose blood pressure cannot be effectively controlled after 4 weeks of monotherapy with levamlodipine maleate or valsartan; 2) To evaluate the safety of SYH9056 tablets in patients with primary mild and moderate hypertension whose blood pressure cannot be effectively controlled after 4 weeks of monotherapy with levamlodipine maleate or valsartan.

Start Date-

Sponsor / Collaborator

CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.

NCT06771245

/ Not yet recruitingPhase 3

A Multicenter, Randomized, Double-Blind Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan/Levamlodipine (SYH9056) Tablets in Patients With Mild to Moderate Essential Hypertension Not Controlled After 4 Weeks of Monotherapy With Amlodipine Or Levamlodipine Alone

SYH9056 tablets are a combination of valsartan and levamlodipine maleate. This is a multicenter, randomized, double-blind, parallel-controlled phase III study, designed to validate the efficacy and safety of SYH9056 tablets in patients with mild-to-moderate essential hypertension not controlled after 4 weeks of treatment with either levamlodipine maleate tablets or valsartan capsules, using either levamlodipine maleate tablets or valsartan capsules as a control. The study consisted of 4 phases: a screening period (2 weeks), an introduction period (4 weeks), a core treatment period (12 weeks), an extended treatment period (12 weeks), and a safety follow-up period (1 week), totaling approximately 31 weeks.

Start Date24 Jan 2025

Sponsor / Collaborator

CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.

CTR20243615

/ Active, not recruitingNot Applicable

缬沙坦马来酸左氨氯地平（SYH9056）片在健康受试者中随机、开放、两制剂、两序列、四周期、单次给药、完全重复交叉空腹和高脂餐后状态下生物等效性试验

[Translation] A randomized, open-label, two-dose, two-sequence, four-period, single-dose, completely repeated crossover bioequivalence study of valsartan maleate and levoamlodipine maleate (SYH9056) tablets in healthy subjects under fasting and high-fat meal conditions

主要目的：考察单次口服（空腹/餐后）石药集团欧意药业有限公司生产的受试制剂缬沙坦马来酸左氨氯地平片（规格：每片含80 mg缬沙坦和2.5 mg左氨氯地平）与以石药集团欧意药业有限公司生产的马来酸左氨氯地平片（玄宁）2.5 mg和Novartis Pharmaceuticals Corporation生产的缬沙坦片（商品名：Diovan）80 mg各1片为参比制剂，在中国健康人体的相对生物利用度，分析受试制剂和参比制剂的生物等效性，为缬沙坦马来酸左氨氯地平片的申报及临床用药提供参考依据。次要目的：评价健康受试者单次空腹和高脂餐后口服受试制剂SYH9056片和参比制剂后的安全性。

[Translation]

Primary objective: To investigate the relative bioavailability of a single oral (fasting/postprandial) dose of the test preparation valsartan levamlodipine maleate tablets (specification: each tablet contains 80 mg valsartan and 2.5 mg levamlodipine) produced by CSPC Ouyi Pharmaceutical Co., Ltd. and 1 tablet each of levamlodipine maleate tablets (Xuanning) 2.5 mg produced by CSPC Ouyi Pharmaceutical Co., Ltd. and valsartan tablets (trade name: Diovan) 80 mg produced by Novartis Pharmaceuticals Corporation as reference preparations in healthy Chinese subjects, analyze the bioequivalence of the test preparation and the reference preparation, and provide a reference basis for the application and clinical use of valsartan levamlodipine maleate tablets. Secondary objective: To evaluate the safety of the test preparation SYH9056 tablets and the reference preparation after a single oral dose on an empty stomach and after a high-fat meal in healthy subjects.

Start Date10 Oct 2024

Sponsor / Collaborator

CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.

100 Clinical Results associated with Valsartan/Levamlodipine Maleate

100 Translational Medicine associated with Valsartan/Levamlodipine Maleate

100 Patents (Medical) associated with Valsartan/Levamlodipine Maleate

100 Deals associated with Valsartan/Levamlodipine Maleate

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Essential Hypertension	Phase 3	CN	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	10 Dec 2024

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