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RECRUITING
NCT06351150
PHASE3

Efficacy and Safety of Angiotensin II Injection Versus Placebo in Patients With Refractory Distributed Shock

Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

A randomized, double-blind, placebo-controlled study on the treatment of refractory distributed shock with angiotensin II injection, with a random ratio of 1:1. Assuming a success rate of 25% for the main therapeutic endpoint in the control group and 50% for the experimental group, a total of 214 subjects will be enrolled, including 107 in the experimental group and 107 in the control group.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Angiotensin II Injection in the Background Treatment of Catecholamines and Other Vasopressors in Chinese Adult Patients With Refractory Distributive Shock

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

214

Start Date

2024-07-23

Completion Date

2027-12

Last Updated

2025-01-23

Healthy Volunteers

No

Interventions

DRUG

Angiotensin II Injection

1、Angiotensin II injection is a naturally occurring octapeptide hormone in the human renin angiotensin aldosterone system (RAAS). It is the main effector molecule of the RAAS system and one of the strongest known vasoconstrictors, involved in neurohumoral regulation.

DRUG

0.9% sodium chloride injection

0.9% sodium chloride injection, not containing active ingredients.

Locations (42)

The Second People's Hospital of Hefei

Hefei, Anhui, China

The Frist Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Beijing Tiantan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The Frist Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The people's Hospital of the University of traditional Chinese medicine in Fujian

Fuzhou, Fujian, China

Gansu Provincial Hospital

Lanzhou, Gansu, China

The First Affiliated Hospital of Sun Yat sen University

Guangzhou, Guangdong, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Qingyuan Hospital Affiliated to Guangzhou Medical University

Qingyuan, Guangdong, China

The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Guilin, Guangxi, China

Liuzhou General Hospital

Liuchow, Guangxi, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

The Affiliated Hospital of Hebei University

Baoding, Hebei, China

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College of huazhong university of science and technology

Wuhan, Hubei, China

Wuhan Third Hospital

Wuhan, Hubei, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Hunan Provincial People's Hospital

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Wuxi People's Hospital

Wuxi, Jiangsu, China

The Frist Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Zibo Central Hospital

Zibo, Shandong, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

The Frist Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The Frist Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Taizhou hospital of Zhejiang Province

Taizhou, Zhejiang, China