Delving into the Latest Updates on Sanofi Ilaç Sanayi ve Ticaret AS with Synapse

Overview

[Translation] A randomized, double-blind, double-dummy, active-controlled, parallel-design, phase III clinical trial to evaluate the efficacy and safety of ezetimibe/rosuvastatin single-tablet combination (SPC) in Chinese adults with primary hypercholesterolemia whose blood lipids are poorly controlled by statins

主要目的：证明与瑞舒伐他汀10 mg（R10）相比，依折麦布10 mg／瑞舒伐他汀10 mg（E10/R10）单片复方制剂治疗8周后降低低密度脂蛋白胆固醇（low-density lipoprotein cholesterol，LDL-C）具有优效性次要目的：评价达到LDL-C目标值的患者比例评价治疗4周后SPC（E10/R10）相较于R10降低LDL-C的疗效评价治疗4周和8周后SPC（E10/R10）相较于R10降低其他血脂指标的疗效评价SPC（E10/R10）和R10的安全性

[Translation]

Primary objective: To demonstrate that the single-tablet combination of ezetimibe 10 mg/rosuvastatin 10 mg (E10/R10) has superior efficacy in reducing low-density lipoprotein cholesterol (LDL-C) after 8 weeks of treatment compared with rosuvastatin 10 mg (R10) Secondary objectives: To evaluate the proportion of patients reaching the target LDL-C value To evaluate the efficacy of SPC (E10/R10) compared with R10 in reducing LDL-C after 4 weeks of treatment To evaluate the efficacy of SPC (E10/R10) compared with R10 in reducing other lipid indicators after 4 and 8 weeks of treatment To evaluate the safety of SPC (E10/R10) and R10

Start Date08 Dec 2020

Sponsor / Collaborator

Sanofi-Aventis Recherche et Développement SA

[+4]

CTR20202108 / CompletedPhase 1

一项在中国健康受试者中评价依折麦布/瑞舒伐他汀固定剂量复方制剂（10 mg/10 mg）与单片药片联合于空腹状态下给药的生物等效性的随机、开放、2-用药、2-周期、2-序列、交叉研究

[Translation] A randomized, open-label, 2-dose, 2-period, 2-sequence, crossover study to evaluate the bioequivalence of a fixed-dose combination of ezetimibe/rosuvastatin (10 mg/10 mg) versus single tablets administered in the fasted state in healthy Chinese subjects

主要目的：证明依折麦布/瑞舒伐他汀固定剂量复方制剂与单片药片联合在中国健康受试者中于空腹状态下给药的生物等效性次要目的：评估两种用药的安全性和耐受性

[Translation]

Primary objective: To demonstrate the bioequivalence of the fixed-dose combination of ezetimibe/rosuvastatin and the single-tablet combination in Chinese healthy subjects administered under the fasting state Secondary objective: To evaluate the safety and tolerability of both medications

Start Date08 Nov 2020

Sponsor / Collaborator

Sanofi Ilaç Sanayi ve Ticaret AS

[+4]

100 Clinical Results associated with Sanofi Ilaç Sanayi ve Ticaret AS

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0 Patents (Medical) associated with Sanofi Ilaç Sanayi ve Ticaret AS

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100 Deals associated with Sanofi Ilaç Sanayi ve Ticaret AS

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100 Translational Medicine associated with Sanofi Ilaç Sanayi ve Ticaret AS

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Pipeline

Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Atorvastatin Calcium/Ezetimibe ( HMG-CoA reductase x NPC1L1 )	Hypercholesterolemia More	Pending
Ezetimibe/Rosuvastatin Calcium ( HMG-CoA reductase x NPC1L1 )	Primary hypercholesterolemia More	Pending