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Clinical trial

A Comparative Study of ZG-801 and Placebo in Patients With Hyperkalemia

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Last updated:11th Aug 2021
Status: Recruiting
Identifier: NCT04955678
A Comparative Study of ZG-801 and Placebo in Patients With Hyperkalemia

Brief Summary:

The purpose of this study is to evaluate the superiority of ZG-801 to placebo in Japanese hyperkalemia patients whose serum potassium value becomes normal in the Run-in period by comparing the change in the value at the Double-blind period week 4, and to further evaluate the efficacy and safety of ZG-801 in Japanese hyperkalemia patients administrated ZG-801 for maximum 9 weeks.

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ZG-801 Phase III Trial - Randomized, Double-blind, Placebo-controlled Trial of ZG-801 in Patients With Hyperkalemia -
Actual Study Start Date: August 3, 2021
Estimated Primary Completion Date: December 2022
Estimated Study Completion Date: February 2023

- Experimental: ZG-801
- Placebo Comparator: Placebo

Category Value
Study type(s) Interventional
Estimated enrolment 100
Actual Study start date 03 August 2021
Estimated Study Completion Date 01 February 2023

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