Back to resultsA Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2 (Re-PHIRE)
Primary Purpose
Pulmonary Hypertension (World Health Organization Group 2), Heart Failure
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD3427
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension (World Health Organization Group 2) focused on measuring Pulmonary Hypertension, Heart Failure, Left Heart Disease, WHO Group 2, Dose-ranging Study, Pulmonary vascular resistance
Eligibility Criteria
Inclusion criteria: Participant must be ≥ 18 years of age inclusive. Participants must have a pre-existing diagnosis of HF, NYHA function class (FC) II to IV, and a pre-existing diagnosis of PH-LHD or likely or intermediate probability of Pulmonary hypertension due to left heart disease (PH-LHD) as per 2022 Pulmonary hypertension due to left heart disease European Society of Cardiology/European Respiratory Society (ESC/ESR) guidelines. Participants must be on stable HF standard of care medication, including diuretics. Participants must have a combination of echocardiographic parameters that show intermediate or high probability of PH as per 2022 ESC/ERS guidelines. Participants must have an on-study elevated pulmonary artery pressure from RHC performed as per RHC manual provided by the Sponsor, at Screening Visit 2: PAWP ≥ 15 mmHg mPAP ≥ 20 mmHg Minimum body weight of 50 kg (inclusive). Capable of giving signed informed consent. Exclusion Criteria Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5. Historical or current evidence of a clinically significant disease or disorder. Decompensated HF or any hospitalisation. Any contraindications to RHC. History of hypersensitivity to SC injections or devices. History of hypersensitivity to drugs with a similar chemical structure or class to AZD3427 or any component of AZD3427 drug product, or ongoing clinically important allergy/hypersensitivity. Known lung disease with Forced expiratory volume in the first second/Vital capacity (FEV1/VC) < 30%. Congenital long QT syndrome. Cardiac ventricular arrhythmia which requires treatment. Participants with atrial fibrillation or flutter and controlled ventricular rate are permitted. History of or anticipated heart transplant or ventricular assist device implantation. Any known planned (scheduled) highly invasive Cardiovascular (CV) procedure (eg, coronary revascularisation, ablation of atrial fibrillation/flutter, valve repair/replacement, aortic aneurysm surgery, etc). Participants who have previously received AZD3427.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
AZD3427 Dose A
AZD3427 Dose B
AZD3427 Dose C
Placebo
Arm Description
The participants will receive single dose of AZD3427 Dose A every 2 weeks for 24 weeks from Day 1 to Day 155.
The participants will receive single dose of AZD3427 Dose B every 2 weeks for 24 weeks from Day 1 to Day 155.
The participants will receive single dose of AZD3427 Dose C every 2 weeks for 24 weeks from Day 1 to Day 155.
The participants will receive single dose placebo every 2 weeks for 24 weeks from Day 1 to Day 155.
Outcomes
Primary Outcome Measures
Change from baseline in Pulmonary Vascular Resistance (PVR)
To evaluate the effect of AZD3427 on PVR parameter compared with placebo as measured by right heart catheterization (RHC) after 24 weeks of treatment in participants with HF and PH Group 2.
Secondary Outcome Measures
Change from baseline in Mean pulmonary arterial pressure (mPAP)
To evaluate the effect of AZD3427 compared with placebo on mPAP parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in Pulmonary artery wedge pressure (PAWP)
To evaluate the effect of AZD3427 compared with placebo on PAWP parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in cardiac output
To evaluate the effect of AZD3427 compared with placebo on cardiac output parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in Stroke Volume (SV)
To evaluate the effect of AZD3427 compared with placebo on SV parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in Ejection fraction (EF)
To evaluate the effect of AZD3427 compared with placebo on EF parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in left ventricular global longitudinal strain (LVGLS)
To evaluate the effect of AZD3427 compared with placebo on LVGLS parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in pulmonary arterial systolic pressure (PASP)
To evaluate the effect of AZD3427 compared with placebo on PASP parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in right ventricle/left ventricle (RV/LV) ratio
To evaluate the effect of AZD3427 compared with placebo on RV/LV parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in right ventricular outflow tract acceleration time (RVOT AT)
To evaluate the effect of AZD3427 compared with placebo on RVOT AT parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in Tricuspid regurgitation velocity (TRV)
To evaluate the effect of AZD3427 compared with placebo on TRV parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in TAPSE/PASP [Tricuspid annular plane systolic excursion/ Pulmonary arterial systolic pressure]
To evaluate the effect of AZD3427 compared with placebo on TAPSE/PASP parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in right ventricular strain/pulmonary arterial systolic pressure (RVS/PASP)
To evaluate the effect of AZD3427 compared with placebo on RVS/PASP parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in inferior vena cava (IVC) diameter with inspiratory collapse
To evaluate the effect of AZD3427 compared with placebo on IVC parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in systemic vascular resistance
To evaluate the effect of AZD3427 compared with placebo on systemic vascular resistance parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in 6-minute walking distance (6MWD)
To evaluate the effect of AZD3427 compared with placebo on function and symptoms using 6MWD parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ TSS)
To evaluate the effect of AZD3427 compared with placebo on function and symptoms using KCCQ TSS parameter after 24 weeks of treatment in participants with HF and PH Group 2. The score ranges from 0 to 100, where a higher score represents a better patient outcome.
Change from baseline in New York Heart Association Functional Class (NYHA FC)
To evaluate the effect of AZD3427 compared with placebo on function and symptoms using NYHA FC parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in serum creatinine
To evaluate the effect of AZD3427 compared with placebo using serum creatinine parameter after 12 and 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
To evaluate the effect of AZD3427 compared with placebo using NT-proBNP parameter after 12 and 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in cystatin C
To evaluate the effect of AZD3427 compared with placebo using cystatin C parameter after 12 and 24 weeks of treatment in participants with HF and PH Group 2.
Change from baseline in eGFR (estimated glomerular filtration rate)
To evaluate the effect of AZD3427 compared with placebo using eGFR parameter after 12 and 24 weeks of treatment in participants with HF and PH Group 2.
Pharmacokinetics (AZD3427 serum exposure)
Serum concentration of AZD3427 summarised by timepoints and dose level.
Number of participants with presence of Anti-drug antibody (ADAs)
To evaluate the immunogenicity of AZD3427 using ADA parameter.
Number of participants with presence of Neutralising antibodies (NAbs)
To evaluate the immunogenicity of AZD3427 using NAbs parameter.
Evaluation of positive ADA titer
To evaluate the immunogenicity of AZD3427 as measured by ADAs.
Full Information
NCT ID
NCT05737940
First Posted
January 20, 2023
Last Updated
October 19, 2023
Sponsor
AstraZeneca
Collaborators
Parexel
1. Study Identification
Unique Protocol Identification Number
NCT05737940
Brief Title
A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2
Acronym
Re-PHIRE
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
April 23, 2025 (Anticipated)
Study Completion Date
June 2, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Parexel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension (World Health Organization Group 2), Heart Failure
Keywords
Pulmonary Hypertension, Heart Failure, Left Heart Disease, WHO Group 2, Dose-ranging Study, Pulmonary vascular resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AZD3427 Dose A
Arm Type
Experimental
Arm Description
The participants will receive single dose of AZD3427 Dose A every 2 weeks for 24 weeks from Day 1 to Day 155.
Arm Title
AZD3427 Dose B
Arm Type
Experimental
Arm Description
The participants will receive single dose of AZD3427 Dose B every 2 weeks for 24 weeks from Day 1 to Day 155.
Arm Title
AZD3427 Dose C
Arm Type
Experimental
Arm Description
The participants will receive single dose of AZD3427 Dose C every 2 weeks for 24 weeks from Day 1 to Day 155.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The participants will receive single dose placebo every 2 weeks for 24 weeks from Day 1 to Day 155.
Intervention Type
Drug
Intervention Name(s)
AZD3427
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The participants will receive SC injection of placebo single dose every 2 weeks for 24 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in Pulmonary Vascular Resistance (PVR)
Description
To evaluate the effect of AZD3427 on PVR parameter compared with placebo as measured by right heart catheterization (RHC) after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Secondary Outcome Measure Information:
Title
Change from baseline in Mean pulmonary arterial pressure (mPAP)
Description
To evaluate the effect of AZD3427 compared with placebo on mPAP parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Title
Change from baseline in Pulmonary artery wedge pressure (PAWP)
Description
To evaluate the effect of AZD3427 compared with placebo on PAWP parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Title
Change from baseline in cardiac output
Description
To evaluate the effect of AZD3427 compared with placebo on cardiac output parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Title
Change from baseline in Stroke Volume (SV)
Description
To evaluate the effect of AZD3427 compared with placebo on SV parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Title
Change from baseline in Ejection fraction (EF)
Description
To evaluate the effect of AZD3427 compared with placebo on EF parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Title
Change from baseline in left ventricular global longitudinal strain (LVGLS)
Description
To evaluate the effect of AZD3427 compared with placebo on LVGLS parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Title
Change from baseline in pulmonary arterial systolic pressure (PASP)
Description
To evaluate the effect of AZD3427 compared with placebo on PASP parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Title
Change from baseline in right ventricle/left ventricle (RV/LV) ratio
Description
To evaluate the effect of AZD3427 compared with placebo on RV/LV parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Title
Change from baseline in right ventricular outflow tract acceleration time (RVOT AT)
Description
To evaluate the effect of AZD3427 compared with placebo on RVOT AT parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Title
Change from baseline in Tricuspid regurgitation velocity (TRV)
Description
To evaluate the effect of AZD3427 compared with placebo on TRV parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Title
Change from baseline in TAPSE/PASP [Tricuspid annular plane systolic excursion/ Pulmonary arterial systolic pressure]
Description
To evaluate the effect of AZD3427 compared with placebo on TAPSE/PASP parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Title
Change from baseline in right ventricular strain/pulmonary arterial systolic pressure (RVS/PASP)
Description
To evaluate the effect of AZD3427 compared with placebo on RVS/PASP parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Title
Change from baseline in inferior vena cava (IVC) diameter with inspiratory collapse
Description
To evaluate the effect of AZD3427 compared with placebo on IVC parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Title
Change from baseline in systemic vascular resistance
Description
To evaluate the effect of AZD3427 compared with placebo on systemic vascular resistance parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Title
Change from baseline in 6-minute walking distance (6MWD)
Description
To evaluate the effect of AZD3427 compared with placebo on function and symptoms using 6MWD parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Title
Change from baseline in Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ TSS)
Description
To evaluate the effect of AZD3427 compared with placebo on function and symptoms using KCCQ TSS parameter after 24 weeks of treatment in participants with HF and PH Group 2. The score ranges from 0 to 100, where a higher score represents a better patient outcome.
Time Frame
Baseline to Week 25
Title
Change from baseline in New York Heart Association Functional Class (NYHA FC)
Description
To evaluate the effect of AZD3427 compared with placebo on function and symptoms using NYHA FC parameter after 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 25
Title
Change from baseline in serum creatinine
Description
To evaluate the effect of AZD3427 compared with placebo using serum creatinine parameter after 12 and 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 13 and Week 25
Title
Change from baseline in N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Description
To evaluate the effect of AZD3427 compared with placebo using NT-proBNP parameter after 12 and 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 13 and Week 25
Title
Change from baseline in cystatin C
Description
To evaluate the effect of AZD3427 compared with placebo using cystatin C parameter after 12 and 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 13 and Week 25
Title
Change from baseline in eGFR (estimated glomerular filtration rate)
Description
To evaluate the effect of AZD3427 compared with placebo using eGFR parameter after 12 and 24 weeks of treatment in participants with HF and PH Group 2.
Time Frame
Baseline to Week 13 and Week 25
Title
Pharmacokinetics (AZD3427 serum exposure)
Description
Serum concentration of AZD3427 summarised by timepoints and dose level.
Time Frame
On Day 15, Day 29, Day 85, Day 127, Day 169, and Day 211
Title
Number of participants with presence of Anti-drug antibody (ADAs)
Description
To evaluate the immunogenicity of AZD3427 using ADA parameter.
Time Frame
On Day 1, Day 15, Day 29, Day 85, Day 169, and Day 211
Title
Number of participants with presence of Neutralising antibodies (NAbs)
Description
To evaluate the immunogenicity of AZD3427 using NAbs parameter.
Time Frame
On Day 1, Day 15, Day 29, Day 85, Day 169, and Day 211
Title
Evaluation of positive ADA titer
Description
To evaluate the immunogenicity of AZD3427 as measured by ADAs.
Time Frame
On Day 1, Day 15, Day 29, Day 85, Day 169, and Day 211
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events and serious adverse events
Description
To evaluate the safety and tolerability of AZD3427 as compared to placebo in participants with HF and PH Group 2
Time Frame
From Randomization (Day 1) up to Follow-up Visit (Day 211)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Participant must be ≥ 18 years of age inclusive.
Participants must have a pre-existing diagnosis of HF, NYHA function class (FC) II to IV, and a pre-existing diagnosis of PH-LHD or likely or intermediate probability of Pulmonary hypertension due to left heart disease (PH-LHD) as per 2022 Pulmonary hypertension due to left heart disease European Society of Cardiology/European Respiratory Society (ESC/ESR) guidelines. Participants must be on stable HF standard of care medication, including diuretics.
Participants must have a combination of echocardiographic parameters that show intermediate or high probability of PH as per 2022 ESC/ERS guidelines.
Participants must have an on-study elevated pulmonary artery pressure from RHC performed as per RHC manual provided by the Sponsor, at Screening Visit 2:
PAWP ≥ 15 mmHg
mPAP ≥ 20 mmHg
Minimum body weight of 50 kg (inclusive).
Capable of giving signed informed consent.
Exclusion Criteria
Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
Historical or current evidence of a clinically significant disease or disorder.
Decompensated HF or any hospitalisation.
Any contraindications to RHC.
History of hypersensitivity to SC injections or devices.
History of hypersensitivity to drugs with a similar chemical structure or class to AZD3427 or any component of AZD3427 drug product, or ongoing clinically important allergy/hypersensitivity.
Known lung disease with Forced expiratory volume in the first second/Vital capacity (FEV1/VC) < 30%.
Congenital long QT syndrome.
Cardiac ventricular arrhythmia which requires treatment. Participants with atrial fibrillation or flutter and controlled ventricular rate are permitted.
History of or anticipated heart transplant or ventricular assist device implantation.
Any known planned (scheduled) highly invasive Cardiovascular (CV) procedure (eg, coronary revascularisation, ablation of atrial fibrillation/flutter, valve repair/replacement, aortic aneurysm surgery, etc).
Participants who have previously received AZD3427.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Individual Site Status
Suspended
Facility Name
Research Site
City
Eisenstadt
ZIP/Postal Code
7000
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1100
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
430033
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kunming
ZIP/Postal Code
650051
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Marche
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20142
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Milan
ZIP/Postal Code
20138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Trieste
ZIP/Postal Code
34149
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kasugai-shi
ZIP/Postal Code
487-0016
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kure-shi
ZIP/Postal Code
737-8505
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Matsumoto-shi
ZIP/Postal Code
390-8621
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Sunto-gun
ZIP/Postal Code
411-8611
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Toyama-shi
ZIP/Postal Code
930-0194
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Deventer
ZIP/Postal Code
7416 SE
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-276
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-005
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toledo
ZIP/Postal Code
45007
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Huddinge
ZIP/Postal Code
141 57
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Calow
ZIP/Postal Code
S44 5BL
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Clydebank
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2
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