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A Phase IIb Randomised, Double-blind, Placebo-controlled, Multi-centre, Dose-ranging Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Due to Left Heart Disease (WHO Group 2)
This study is intended to assess the ability of AZD3427 to reduce pulmonary vascular resistance (PVR) after 24 weeks of treatment in participants with heart failure (HF) and pulmonary hypertension (PH) Group 2
This study is a randomized, placebo-controlled, multi-centre, dose-ranging study of AZD3427 in participants with heart failure and pulmonary hypertension due to left heart disease (World Health Organisation \[WHO\] Group 2). Approximately 220 participants will be randomised to 4 treatment groups (in a 1:1:1:1 ratio) to receive a subcutaneous (SC) injection of AZD3427 or placebo every 2 weeks for 24 weeks. This study will evaluate 3 dose levels of AZD3427: Dose A, Dose B, and Dose C. Dose modification is not applicable for this study. The study will be conducted in approximately 60 study centres across an estimated 15 countries. The study will include approximately 16 study visits: 2 visits during the Screening Period,13 visits during the Treatment Period, and one visit during the Follow-up Period. The expected total duration of the study is 32 to 37 weeks, depending on the length of the Screening Period.
Age
18 - 130 years
Sex
ALL
Healthy Volunteers
No
Research Site
Beverly Hills, California, United States
Research Site
La Jolla, California, United States
Research Site
New Haven, Connecticut, United States
Research Site
Baltimore, Maryland, United States
Research Site
St Louis, Missouri, United States
Research Site
Omaha, Nebraska, United States
Research Site
Rock Hill, South Carolina, United States
Research Site
Linz, Austria
Research Site
Vienna, Austria
Research Site
Edmonton, Alberta, Canada
Start Date
April 24, 2023
Primary Completion Date
July 15, 2025
Completion Date
August 25, 2025
Last Updated
September 24, 2025
260
ACTUAL participants
AZD3427
DRUG
Placebo
DRUG
Lead Sponsor
AstraZeneca
Collaborators
NCT07191730
NCT07484009
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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