NCT06351150

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vasodilatory Shock

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-23
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2024-04-08
• Last updated: 2025-01-23

Locations

42 sites across 1 country: China