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Efficacy and Safety Study of Etripamil Nasal Spray Self-Administration for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia
Sponsor: Corxel Pharmaceuticals
Summary
To determine whether etripamil nasal spray (NS) self-administered by Chinese patients is superior to placebo at terminating episodes of PSVT in an at-home setting; To evaluate the efficacy of etripamil NS self-administered by Chinese patients compared with placebo on a range of clinical markers. To evaluate the safety of etripamil NS self-administered by Chinese patients compared with placebo
Official title: Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Etripamil Nasal Spray Self-Administration for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia in Chinese Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2022-06-30
Completion Date
2024-12-10
Last Updated
2026-11-02
Healthy Volunteers
No
Interventions
Etripamil NS 70 mg
Etripamil NS 70 mg will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
Placebo
Placebo will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
Locations (53)
Baotou Central Hospital
Baotou, China
The First Affiliated Hospital of Baotou Medical College
Baotou, China
Beijing Anzhen Hospital; Capital Medical University
Beijing, China
Beijing Hospital
Beijing, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Chui Yang Liu Hospital Affiliated to Tsinghua University
Beijing, China
Peking Union Medical College Hospital
Beijing, China
The Central Hospital of China Aerospace Corporation
Beijing, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
The Third Xiangya Hospital of Central South University
Changsha, China
Xiangya Hospital, Central South University
Changsha, China
Changzhou No.2 People's Hospital
Changzhou, China
The First Affiliated Hospital of Chengdu Medical College
Chengdu, China
The First Hospital of Jilin University
Ch’ang-ch’un, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, China
People's Hospital of Deyang City
Deyang, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Nanfang Hospital of Southern Medical University
Guangzhou, China
Guizhou Provincial People's Hospital
Guiyang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
The First People's Hospital of Hangzhou Linping District
Hangzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
Huai'an First People's Hospital
Huai'an, China
Huainan First People's Hospital
Huainan, China
Huizhou Municipal Central Hospital
Huizhou, China
Jinan Central Hospital
Jinan, China
Shandong Province Qianfoshan Hospital
Jinan, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, China
Lanzhou University Second Hospital
Lanzhou, China
Lishui Municipal Central Hospital
Lishui, China
The First Affiliated Hospital of Henan Science and Technology University
Luoyang, China
Mianyang Central Hospital
Mianyang, China
The Nanchang Third Hospital
Nanchang, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Jiangsu Province Hospital
Nanjing, China
Nanjing Drum Tower Hospital
Nanjing, China
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, China
The second affiliated Hospital of Guangxi Medical University
Nanning, China
Nanyang Second General Hospital
Nanyang, China
Ningbo First Hospital
Ningbo, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, China
Shanghai Pudong New Area People's Hospital
Shanghai, China
Shanghai Tongren Hospital
Shanghai, China
Shangrao People's Hospital
Shangrao, China
Shanxi Cardiovascular Hospital
Taiyuan, China
Jiangsu Taizhou People's Hospital
Taizhou, China
Binhai Hospital (Tianjin Fifth Central Hospital)
Tianjin, China
Tianjin Medical University General Hospital
Tianjin, China
CR and WISCO General Hospital
Wuhan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Xingtai Third Hospital
Xingtai, China
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Yiwu, China
ZiBo Central Hospital
Zibo, China