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

Recruiting Phase 3 Interventional Study
Vasodilatory Shock
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
214 (estimated)
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * age: 18 years to 75 years old, male or female; * diagnosis of distributive shock; * on the basis of the treatment of total vasoactive drugs dose \> 0.2 μg/kg/min norepinephrine (or equivalent dose of another vasoactive drug: such as epinephrine \> 0.2 μg/kg/min, dopamine \> 30…
Contacts

Xiangdong Guan, M.D.

13802925067

guanxiangdong1962@163.com

CONTACT

Yan Kang, M.D.

13808041931

kangyan_hx@163.com

CONTACT