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A Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicentre, Phase 2a Study to Assess Target Engagement, Safety and Tolerability of AZD4831 in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
A randomized, double-blind, placebo-controlled, parallel group, multicentre study in patients with Heart Failure with preserved Ejection Fraction (HFpEF). The study will be conducted at approximately 15 sites in 5 countries. Approximately 96 patients will be randomized to AZD4831 or placebo (treatment duration 90 days).
This is a randomized, double-blind, placebo controlled, parallel group, multicentre study in patients with Heart Failure with preserved Ejection Fraction (HFpEF) and mid-range Ejection Fraction (HRmrEF). The study will be conducted at approximately 15 sites in 5 countries (USA, Sweden, Denmark, Finland, Netherlands). Patients suitable for the study will be checked for eligibility, signing the informed consent and enrolled to the study at visit 1. The study will be divided into two parts, Part A and Part B. In part A 37 patients will be randomized at visit 2 in a 2:1 ratio to once daily dosing of AZD4831 or matching placebo for approximately 90 days. After approximately 30 days of treatment, an interim analysis will be done to analyse the safety, tolerability and target engagement. After the evaluation, the randomization to Part B may proceed. In Part B the approximate 59 remaining patients will be randomized and treated for approximately 90 days.
Age
45 - 85 years
Sex
ALL
Healthy Volunteers
No
Research Site
Chicago, Illinois, United States
Research Site
Boston, Massachusetts, United States
Research Site
Aarhus N, Denmark
Research Site
Herlev, Denmark
Research Site
Hvidovre, Denmark
Research Site
Odense C, Denmark
Research Site
Turku, Finland
Research Site
Deventer, Netherlands
Research Site
Dordrecht, Netherlands
Research Site
Groningen, Netherlands
Start Date
December 11, 2018
Primary Completion Date
May 7, 2020
Completion Date
May 7, 2020
Last Updated
July 19, 2021
41
ACTUAL participants
AZD4831
DRUG
Placebo
DRUG
Lead Sponsor
AstraZeneca
NCT07484009
NCT07191730
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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