Study identifier:D8330C00003
ClinicalTrials.gov identifier:NCT05737940
EudraCT identifier:N/A
CTIS identifier:2022-502382-25-00
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)
Pulmonary Hypertension (World Health Organization Group 2)
Phase 2
No
AZD3427, Placebo
All
260
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 May 2025 by AstraZeneca
AstraZeneca
PAREXEL
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.
Location
Location
Warszawa, Poland, 02-005
Location
Wien, Austria, 1100
Location
Changsha, China, 430033
Location
Baltimore, MD, United States, 21287
Location
Toyama-shi, Japan, 930-0194
Location
Milano, Italy, 20142
Location
Gdansk, Poland, 80-952
Location
New Haven, CT, United States, 06519
Arms | Assigned Interventions |
---|---|
Experimental: AZD3427 Dose A The participants will receive single dose of AZD3427 Dose A every 2 weeks for 24 weeks from Day 1 to Day 155. | Drug: AZD3427 The participants will receive AZD3427 SC injection single dose of either Dose A or Dose B or Dose C every 2 weeks for 24 weeks. |
Experimental: AZD3427 Dose B The participants will receive single dose of AZD3427 Dose B every 2 weeks for 24 weeks from Day 1 to Day 155. | Drug: AZD3427 The participants will receive AZD3427 SC injection single dose of either Dose A or Dose B or Dose C every 2 weeks for 24 weeks. |
Experimental: AZD3427 Dose C The participants will receive single dose of AZD3427 Dose C every 2 weeks for 24 weeks from Day 1 to Day 155. | Drug: AZD3427 The participants will receive AZD3427 SC injection single dose of either Dose A or Dose B or Dose C every 2 weeks for 24 weeks. |
Placebo Comparator: Placebo The participants will receive single dose of placebo every 2 weeks for 24 weeks from Day 1 to Day 155. | Drug: Placebo The participants will receive SC injection of placebo single dose every 2 weeks for 24 weeks. |
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