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COMPLETED
NCT05410860
PHASE3

Efficacy and Safety Study of Etripamil Nasal Spray Self-Administration for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia

Sponsor: Corxel Pharmaceuticals

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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