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Study of Verinurad in Heart Failure With Preserved Ejection Fraction (AMETHYST)

Primary Purpose

Heart Failure With Preserved Ejection Fraction (HFpEF)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Verinurad
Allopurinol
Placebo for verinurad
Placebo for allopurinol
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction (HFpEF) focused on measuring Phase 2,, Double-Blind,, Placebo and Active Control,, Verinurad,, Allopurinol,, HFpEF,, Heart Failure

Eligibility Criteria

40 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient must be ≥ 40 years of age at the time of signing the ICF
  • Patients with hyperuricaemia defined as sUA level of > 6 mg/dL.

  • Patients with documented diagnosis of symptomatic HFpEF according to all of the following criteria:

    1. Have NYHA functional class II-III at enrolment
    2. Have medical history of typical symptoms/signs of HF > 6 weeks before enrolment
    3. LVEF ≥ 45%
    4. NT-proBNP ≥ 125 pg/mL (≥ 14.75 pmol/L) at Visit 1 for patients without ongoing atrial fibrillation/flutter.

  • Patients able to exercise to near exhaustion during a CPET as exhibited by RER

    ≥ 1.05 during CPET conducted during screening. If patient does not achieve RER ≥ 1.05 the CPET may be repeated once, at least 48 hours but less than 2 weeks (but before randomisation) after the initial test; in such cases the second test will serve as baseline.

  • Male or female

Exclusion Criteria:

  • eGFR < 30ml/min/1.73m2 (based on CKD-EPI formula)
  • Presence of any condition that precludes exercise testing
  • Known history of a documented LVEF < 40%
  • Probable alternative or concomitant diagnoses which in the opinion of the Investigator could account for the patient's HF symptoms and signs (eg, anaemia, hypothyroidism)

  • Known carrier of the Human Leukocyte Antigen-B (HLA-B) *58:01 allele: HLA-B

    *58:01 genotyping is mandatory prior to randomization for all patients.

  • Patients diagnosed with tumor lysis syndrome or Lesch-Nyhan syndrome
  • Patients who are severely physically or mentally incapacitated and who in the opinion of investigator are unable to perform the patients' tasks associated with the protocol
  • Presence of any condition which, in the opinion of the investigator, places the patient at undue risk or potentially jeopardises the quality of the data to be generated
  • Current acute decompensated HF or hospitalisation due to decompensated HF < 4 weeks prior to enrolment
  • Myocardial infarction, unstable angina, coronary revascularisation (percutaneous coronary intervention or coronary artery bypass grafting), ablation of atrial flutter/fibrillation, valve repair/replacement, implantation of a cardiac resynchronisation therapy device, stroke or transient ischemic attack within 6 months prior to enrolment.
  • Planned coronary revascularisation, ablation of atrial flutter/fibrillation and/or valve repair/replacement
  • Atrial fibrillation with persistent resting heart rate > 110 beats per minute.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Verinurad 12 + allopurinol

Allopurinol alone

Placebo

Arm Description

Dose [mg] verinurad/allopurinol: Step 1 - titration_3/100 Step 2 - titration_7.5/200 Step 3 - target dose 12/300

Dose [mg] verinurad/allopurinol: Step 1 - titration_0/100 Step 2 - titration_0/200 Step 3 - target dose 0/300

Placebo [mg] in 3 steps 0/0

Outcomes

Primary Outcome Measures

Change From Baseline at Week 32 in Peak V02 Consumption in Verinurad + Allopurinol Compared to Placebo (ANCOVA Model)
Mean change from baseline in peak VO2 at Week 32 between the treatment groups was compared using change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and baseline peak VO2 included as covariate. H0: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs placebo) = 0 Ha: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs placebo) ≠ 0 A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level. Since this was the first test in the hierarchical test sequence and endpoint was not rejected at a two-sided 0.05 level, the testing sequence did not continue.

Secondary Outcome Measures

Change From Baseline at Week 32 in Peak V02 Consumption in Verinurad+ Allopurinol Compared to Allopurinol Monotherapy (ANCOVA Model)
Mean change from baseline in peak VO2 at Week 32 between the treatment groups was compared using change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and baseline peak VO2 included as covariate. H0: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs allopurinol) = 0 Ha: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs allopurinol) ≠ 0 A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level.
Change From Baseline at Week 32 in KCCQ-TSS in Verinurad+ Allopurinol Compared to Placebo (MMRM)
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item assessment that measures the patient's perception of their health status, which includes heart failure-related symptoms (frequency, burden, recent change), impact on physical and social function, self-efficacy and knowledge, and how the patient's heart failure affects their quality of life. The Total Symptom Score (TSS) averages the frequency domain and the symptom burden domain subscales, which each range from 0 to 100. The TSS ranges from 0-100 (higher scores = better health status). Mean change from baseline in KCCQ-TSS at Week 32 between the treatment groups was compared using MMRM analysis, with change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS included as covariates. The number analyzed at each timepoint represents the number of subjects with data at each visit.
Change From Baseline at Week 32 in KCCQ-TSS in Verinurad+ Allopurinol Compared to Allopurinol Monotherapy (MMRM)
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item assessment that measures the patient's perception of their health status, which includes heart failure-related symptoms (frequency, burden, recent change), impact on physical and social function, self-efficacy and knowledge, and how the patient's heart failure affects their quality of life. The Total Symptom Score (TSS) averages the frequency domain and the symptom burden domain subscales, which each range from 0 to 100. The TSS ranges from 0-100 (higher scores = better health status). Mean change from baseline in KCCQ-TSS at Week 32 between the treatment groups was compared using MMRM analysis, with change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS included as covariates. The number analyzed at each timepoint represents the number of subjects with data at each visit.

Full Information

First Posted
March 13, 2020
Last Updated
June 12, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04327024
Brief Title
Study of Verinurad in Heart Failure With Preserved Ejection Fraction
Acronym
AMETHYST
Official Title
A Phase 2, Multicentre, Double-Blind, Placebo and Active Control Efficacy and Safety Study to Evaluate Verinurad Combined With Allopurinol in Heart Failure With Preserved Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 19, 2020 (Actual)
Primary Completion Date
April 29, 2022 (Actual)
Study Completion Date
April 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
International, Multicenter, Double-Blind, Placebo and Active Control Efficacy and Safety Study to Evaluate Verinurad combined with Allopurinol in Heart Failure with Preserved Ejection Fraction
Detailed Description
Evidence shows independent associations between hyperuricaemia and the risk of cardio-renal conditions, including heart failure (HF). Serum uric acid (sUA) is also a strong prognostic factor and correlates with other markers of poor prognosis in HF patients with preserved ejection fraction (HFpEF), and an estimated 1/2-2/3 of HFpEF patients have hyperuricaemia. HFpEF is a microvascular disease likely partly driven by endothelial dysfunction and inflammation in coronary vessel walls. Uric acid crystals have been identified in coronary vessel walls in some hyperuricaemic patients. Uric acid transporter 1 (URAT1) is responsible for reabsorption of uric acid (UA) in the proximal tubule. Inhibition of URAT1 results in increased urinary excretion of UA and lowering of uric acid in the blood. Verinurad is a novel URAT1 inhibitor in Phase 2 development for chronic kidney disease (CKD) and HF. Verinurad combined with the xanthine oxidase (XO) inhibitors (XOI) febuxostat or allopurinol has been shown to lower sUA in patients with recurrent gout in Phase 2 studies by up to approximately 80%. The primary objective of this Phase 2 study is to assess the effect of a combination of verinurad and allopurinol on exercise capacity in patients with HFpEF. The secondary objectives are to assess effect of combination of verinurad and allopurinol in comparison to allopurinol monotheraphy on excercise capacity dwhich will be measured in peak VO2 as well as effect of verinurad and allopurinol compared to placebo and to allopurinol monotheraphy on Kansas City cardiomyopathy questionnaire (KCCQ)-total symptom score (TSS). A sub-study aims to investigate the relationship between UA crystals and inflammation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction (HFpEF)
Keywords
Phase 2,, Double-Blind,, Placebo and Active Control,, Verinurad,, Allopurinol,, HFpEF,, Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verinurad 12 + allopurinol
Arm Type
Experimental
Arm Description
Dose [mg] verinurad/allopurinol: Step 1 - titration_3/100 Step 2 - titration_7.5/200 Step 3 - target dose 12/300
Arm Title
Allopurinol alone
Arm Type
Experimental
Arm Description
Dose [mg] verinurad/allopurinol: Step 1 - titration_0/100 Step 2 - titration_0/200 Step 3 - target dose 0/300
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo [mg] in 3 steps 0/0
Intervention Type
Drug
Intervention Name(s)
Verinurad
Other Intervention Name(s)
verinurad titration 3 - 7.5 - 12mg, allopurinol titration 100 - 200 - 300 mg
Intervention Description
The treatment will be titrated in 3 steps for target low dose (3 mg), intermediate dose (7.5 mg) and high dose (12mg) of verinurad. Drug: Allopurinol The treatment will be titrated in 3 steps. Low dose (100mg), intermediate (200mg) and high dose (300mg) of allopurinol.
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Other Intervention Name(s)
allopurinol titration 100 - 200 - 300 mg
Intervention Description
Study treatments will be titrated in 3 steps: Low dose (100mg), intermediate (200mg) and high dose (300mg) of allopurinol
Intervention Type
Drug
Intervention Name(s)
Placebo for verinurad
Other Intervention Name(s)
Placebo
Intervention Description
Matching Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo for allopurinol
Other Intervention Name(s)
Placebo
Intervention Description
Matching tablet
Primary Outcome Measure Information:
Title
Change From Baseline at Week 32 in Peak V02 Consumption in Verinurad + Allopurinol Compared to Placebo (ANCOVA Model)
Description
Mean change from baseline in peak VO2 at Week 32 between the treatment groups was compared using change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and baseline peak VO2 included as covariate. H0: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs placebo) = 0 Ha: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs placebo) ≠ 0 A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level. Since this was the first test in the hierarchical test sequence and endpoint was not rejected at a two-sided 0.05 level, the testing sequence did not continue.
Time Frame
From baseline to Week 32
Secondary Outcome Measure Information:
Title
Change From Baseline at Week 32 in Peak V02 Consumption in Verinurad+ Allopurinol Compared to Allopurinol Monotherapy (ANCOVA Model)
Description
Mean change from baseline in peak VO2 at Week 32 between the treatment groups was compared using change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and baseline peak VO2 included as covariate. H0: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs allopurinol) = 0 Ha: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs allopurinol) ≠ 0 A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level.
Time Frame
From baseline to Week 32
Title
Change From Baseline at Week 32 in KCCQ-TSS in Verinurad+ Allopurinol Compared to Placebo (MMRM)
Description
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item assessment that measures the patient's perception of their health status, which includes heart failure-related symptoms (frequency, burden, recent change), impact on physical and social function, self-efficacy and knowledge, and how the patient's heart failure affects their quality of life. The Total Symptom Score (TSS) averages the frequency domain and the symptom burden domain subscales, which each range from 0 to 100. The TSS ranges from 0-100 (higher scores = better health status). Mean change from baseline in KCCQ-TSS at Week 32 between the treatment groups was compared using MMRM analysis, with change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS included as covariates. The number analyzed at each timepoint represents the number of subjects with data at each visit.
Time Frame
From baseline to Week 22 and Week 32
Title
Change From Baseline at Week 32 in KCCQ-TSS in Verinurad+ Allopurinol Compared to Allopurinol Monotherapy (MMRM)
Description
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item assessment that measures the patient's perception of their health status, which includes heart failure-related symptoms (frequency, burden, recent change), impact on physical and social function, self-efficacy and knowledge, and how the patient's heart failure affects their quality of life. The Total Symptom Score (TSS) averages the frequency domain and the symptom burden domain subscales, which each range from 0 to 100. The TSS ranges from 0-100 (higher scores = better health status). Mean change from baseline in KCCQ-TSS at Week 32 between the treatment groups was compared using MMRM analysis, with change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS included as covariates. The number analyzed at each timepoint represents the number of subjects with data at each visit.
Time Frame
From baseline to Week 22 and Week 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must be ≥ 40 years of age at the time of signing the ICF Patients with hyperuricaemia defined as sUA level of > 6 mg/dL. Patients with documented diagnosis of symptomatic HFpEF according to all of the following criteria: Have NYHA functional class II-III at enrolment Have medical history of typical symptoms/signs of HF > 6 weeks before enrolment LVEF ≥ 45% NT-proBNP ≥ 125 pg/mL (≥ 14.75 pmol/L) at Visit 1 for patients without ongoing atrial fibrillation/flutter. Patients able to exercise to near exhaustion during a CPET as exhibited by RER ≥ 1.05 during CPET conducted during screening. If patient does not achieve RER ≥ 1.05 the CPET may be repeated once, at least 48 hours but less than 2 weeks (but before randomisation) after the initial test; in such cases the second test will serve as baseline. Male or female Exclusion Criteria: eGFR < 30ml/min/1.73m2 (based on CKD-EPI formula) Presence of any condition that precludes exercise testing Known history of a documented LVEF < 40% Probable alternative or concomitant diagnoses which in the opinion of the Investigator could account for the patient's HF symptoms and signs (eg, anaemia, hypothyroidism) Known carrier of the Human Leukocyte Antigen-B (HLA-B) *58:01 allele: HLA-B *58:01 genotyping is mandatory prior to randomization for all patients. Patients diagnosed with tumor lysis syndrome or Lesch-Nyhan syndrome Patients who are severely physically or mentally incapacitated and who in the opinion of investigator are unable to perform the patients' tasks associated with the protocol Presence of any condition which, in the opinion of the investigator, places the patient at undue risk or potentially jeopardises the quality of the data to be generated Current acute decompensated HF or hospitalisation due to decompensated HF < 4 weeks prior to enrolment Myocardial infarction, unstable angina, coronary revascularisation (percutaneous coronary intervention or coronary artery bypass grafting), ablation of atrial flutter/fibrillation, valve repair/replacement, implantation of a cardiac resynchronisation therapy device, stroke or transient ischemic attack within 6 months prior to enrolment. Planned coronary revascularisation, ablation of atrial flutter/fibrillation and/or valve repair/replacement Atrial fibrillation with persistent resting heart rate > 110 beats per minute.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalane Kitzman, MD
Organizational Affiliation
1326 Riverview Road Ext Lexington, NC 27292-1764 USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
Research Site
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Research Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Research Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Research Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1006ACC
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1119ACN
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
Research Site
City
Mar del Plata
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Research Site
City
Mar del Plata
ZIP/Postal Code
B7600GNY
Country
Argentina
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Research Site
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Facility Name
Research Site
City
Chermside
ZIP/Postal Code
4032
Country
Australia
Facility Name
Research Site
City
Geelong
ZIP/Postal Code
3220
Country
Australia
Facility Name
Research Site
City
Milton
ZIP/Postal Code
4064
Country
Australia
Facility Name
Research Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1G 3Y8
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Research Site
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Research Site
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Research Site
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Research Site
City
Würzburg
ZIP/Postal Code
97078
Country
Germany
Facility Name
Research Site
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Research Site
City
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Research Site
City
Querétaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Research Site
City
Chojnice
ZIP/Postal Code
89-600
Country
Poland
Facility Name
Research Site
City
Chrzanów
ZIP/Postal Code
32-500
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Facility Name
Research Site
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Research Site
City
Aramil
ZIP/Postal Code
624002
Country
Russian Federation
Facility Name
Research Site
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
199226
Country
Russian Federation
Facility Name
Research Site
City
St Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Research Site
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation
Facility Name
Research Site
City
Brezno
ZIP/Postal Code
97742
Country
Slovakia
Facility Name
Research Site
City
Lucenec
ZIP/Postal Code
984 01
Country
Slovakia
Facility Name
Research Site
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Research Site
City
Svidnik
ZIP/Postal Code
08901
Country
Slovakia

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 de-identified 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
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D5496C00005&amp;attachmentIdentifier=fce5ac49-abba-45d6-97e6-9c743db21176&amp;fileName=Clinical_Study_Protocol_redacted.pdf&amp;versionIdentifier=
Description
Clinical Study Protocol Redacted
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D5496C00005&amp;attachmentIdentifier=99f91757-f330-4480-b3fa-db052dbed5ca&amp;fileName=Clinical_Study_Report_synopsis_redacted.pdf&amp;versionIdentifier=
Description
CSR_synopsis_redacted
URL
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Description
Statistical Analysis Plan-redacted

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Study of Verinurad in Heart Failure With Preserved Ejection Fraction

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