A study to investigate the safety and efficacy of ZS in patients with hyperkalemia - HARMONIZE GL

Study identifier:D9480C00002

ClinicalTrials.gov identifier:NCT02875834

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A phase 3 multicenter, prospective, randomized, double-blind, placebo-controlled study to investigate the safety and efficacy of ZS, in patients with hyperkalemia-HARMONIZE Global

Medical condition

Hyperkalemia

Phase

Phase 3

Healthy volunteers

No

Study drug

Sodium Zirconium Cyclosilicate (ZS) 10g, Sodium Zirconium Cyclosilicate (ZS) 5g, Sodium Zirconium Cyclosilicate (ZS) 10g, Placebo

Sex

All

Actual enrollment

267

Study type

Interventional

Age

18 Years - 90 Years

Date

Study Start Date: 03 Mar 2017
Primary Completion Date: 14 Feb 2018
Study Completion Date: 14 Feb 2018

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2020 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria