Back to resultsA Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension (BaxHTN)
Primary Purpose
Uncontrolled Hypertension, Resistant Hypertension
Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Baxdrostat
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Uncontrolled Hypertension focused on measuring Hypertension, Uncontrolled hypertension, Resistant hypertension, Blood pressure, Baxdrostat, CIN-107, Aldosterone, Aldosterone synthase
Eligibility Criteria
Inclusion Criteria: Male or female participants must be ≥ 18 years old Mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmHg and < 170 mmHg at Screening Fulfil at least 1 of the following 2 criteria: uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from different therapeutic classes (at least one should be a diuretic), at maximum tolerated dose in the judgement of the Investigator rHTN subpopulation: have a stable regimen of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one should be a diuretic), at maximum tolerated dose in the judgement of the Investigator Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening Randomisation Criterion: Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at baseline Exclusion Criteria: Mean sitting systolic blood pressure on attended automated office blood pressure measurement ≥ 170 mmHg at Randomisation Mean seated diastolic blood pressure on attended automated office blood pressure measurement ≥ 110 mmHg at Randomisation Serum sodium level < 135 mmol/L at Screening Has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation New York Heart Association functional heart failure class IV at Screening Persistent atrial fibrillation
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
2 mg baxdrostat
1 mg baxdrostat
Placebo
Arm Description
2 mg baxdrostat administered orally, once daily (QD).
1 mg baxdrostat administered orally, once daily (QD).
Placebo administered orally, once daily (QD).
Outcomes
Primary Outcome Measures
Change from baseline in seated systolic blood pressure for 2 mg baxdrostat
To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12
Change from baseline in seated systolic blood pressure for 1 mg baxdrostat
To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12
Secondary Outcome Measures
Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat
To assess the effect of 2 mg baxdrostat vs placebo on seated systolic blood pressure (SBP) at 8 weeks after randomised withdrawal
Change from baseline in seated SBP for 2 mg baxdrostat
To assess the effect of 2 mg baxdrostat vs placebo on seated SBP at Week 12 in the resistant hypertension (rHTN) subpopulation
Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat
To assess the effect of 2 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) at Week 12
Achieving seated SBP < 130 mmHg for 2 mg baxdrostat
To assess the effect of 2 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12
Change from baseline in seated SBP for 1 mg baxdrostat
To assess the effect of 1 mg baxdrostat vs placebo on seated SBP at Week 12 in the rHTN subpopulation
Change from baseline in seated DBP for 1 mg baxdrostat
To assess the effect of 1 mg baxdrostat vs placebo on seated DBP at Week 12
Achieving seated SBP < 130 mmHg for 1 mg baxdrostat
To assess the effect of 1 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12
The change from baseline in the mean ambulatory 24-hour SBP as measured by ambulatory blood pressure monitoring (ABPM) for 2 mg baxdrostat
To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average SBP at Week 12
The change from baseline in the mean ambulatory 24-hour SBP as measured by ABPM for 1 mg baxdrostat
To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP at Week 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06034743
Brief Title
A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
Acronym
BaxHTN
Official Title
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
October 13, 2025 (Anticipated)
Study Completion Date
October 13, 2025 (Anticipated)
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
This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncontrolled Hypertension, Resistant Hypertension
Keywords
Hypertension, Uncontrolled hypertension, Resistant hypertension, Blood pressure, Baxdrostat, CIN-107, Aldosterone, Aldosterone synthase
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
720 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2 mg baxdrostat
Arm Type
Experimental
Arm Description
2 mg baxdrostat administered orally, once daily (QD).
Arm Title
1 mg baxdrostat
Arm Type
Experimental
Arm Description
1 mg baxdrostat administered orally, once daily (QD).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally, once daily (QD).
Intervention Type
Drug
Intervention Name(s)
Baxdrostat
Other Intervention Name(s)
CIN-107
Intervention Description
Baxdrostat tablet administered orally, once daily (QD). Unit dose strengths:
1 mg per tablet for 1 mg baxdrostat Arm;
2 mg per tablet for 2 mg baxdrostat Arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
Primary Outcome Measure Information:
Title
Change from baseline in seated systolic blood pressure for 2 mg baxdrostat
Description
To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12
Time Frame
At Week 12
Title
Change from baseline in seated systolic blood pressure for 1 mg baxdrostat
Description
To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12
Time Frame
At Week 12
Secondary Outcome Measure Information:
Title
Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat
Description
To assess the effect of 2 mg baxdrostat vs placebo on seated systolic blood pressure (SBP) at 8 weeks after randomised withdrawal
Time Frame
At Week 32
Title
Change from baseline in seated SBP for 2 mg baxdrostat
Description
To assess the effect of 2 mg baxdrostat vs placebo on seated SBP at Week 12 in the resistant hypertension (rHTN) subpopulation
Time Frame
At Week 12
Title
Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat
Description
To assess the effect of 2 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) at Week 12
Time Frame
At Week 12
Title
Achieving seated SBP < 130 mmHg for 2 mg baxdrostat
Description
To assess the effect of 2 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12
Time Frame
At Week 12
Title
Change from baseline in seated SBP for 1 mg baxdrostat
Description
To assess the effect of 1 mg baxdrostat vs placebo on seated SBP at Week 12 in the rHTN subpopulation
Time Frame
At Week 12
Title
Change from baseline in seated DBP for 1 mg baxdrostat
Description
To assess the effect of 1 mg baxdrostat vs placebo on seated DBP at Week 12
Time Frame
At Week 12
Title
Achieving seated SBP < 130 mmHg for 1 mg baxdrostat
Description
To assess the effect of 1 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12
Time Frame
At Week 12
Title
The change from baseline in the mean ambulatory 24-hour SBP as measured by ambulatory blood pressure monitoring (ABPM) for 2 mg baxdrostat
Description
To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average SBP at Week 12
Time Frame
At Week 12
Title
The change from baseline in the mean ambulatory 24-hour SBP as measured by ABPM for 1 mg baxdrostat
Description
To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP at Week 12
Time Frame
At Week 12
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events (AEs)
Description
To assess the safety and tolerability of baxdrostat versus placebo. Occurrence of adverse events (AE), including serious adverse events (SAEs), adverse events leading to treatment discontinuation (DAE) and adverse events of special interest (AESI).
Time Frame
Up to Week 54
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:
Male or female participants must be ≥ 18 years old
Mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmHg and < 170 mmHg at Screening
Fulfil at least 1 of the following 2 criteria:
uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from different therapeutic classes (at least one should be a diuretic), at maximum tolerated dose in the judgement of the Investigator
rHTN subpopulation: have a stable regimen of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one should be a diuretic), at maximum tolerated dose in the judgement of the Investigator
Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening
Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening
Randomisation Criterion:
Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at baseline
Exclusion Criteria:
Mean sitting systolic blood pressure on attended automated office blood pressure measurement ≥ 170 mmHg at Randomisation
Mean seated diastolic blood pressure on attended automated office blood pressure measurement ≥ 110 mmHg at Randomisation
Serum sodium level < 135 mmol/L at Screening
Has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation
New York Heart Association functional heart failure class IV at Screening
Persistent atrial fibrillation
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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
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United States
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Research Site
City
Birmingham
State/Province
Alabama
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35233
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United States
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City
Saraland
State/Province
Alabama
ZIP/Postal Code
36571
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United States
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City
Scottsdale
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Arizona
ZIP/Postal Code
85259
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United States
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City
Sun City West
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Arizona
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85375
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United States
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City
Surprise
State/Province
Arizona
ZIP/Postal Code
85374
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United States
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City
Little Rock
State/Province
Arkansas
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72211
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United States
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Anaheim
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California
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92805
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United States
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Fresno
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California
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93720
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United States
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Lincoln
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California
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95648
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United States
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Orange
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California
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92868
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United States
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Rancho Cucamonga
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California
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91730
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United States
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Stanford
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California
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94304
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United States
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New Haven
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Connecticut
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United States
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Clearwater
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Florida
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33765
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United States
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Jacksonville
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Florida
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32204
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United States
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Port Orange
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Florida
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32127
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United States
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Atlanta
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Georgia
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30344
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Decatur
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Georgia
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30033
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Chicago
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Illinois
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60612
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United States
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Hinsdale
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Illinois
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60521
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United States
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Springfield
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Illinois
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62702
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United States
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City
Munster
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Indiana
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46321
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United States
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Lexington
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Kentucky
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40503
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United States
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Boston
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Massachusetts
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02215
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United States
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Troy
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Michigan
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48085
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Olive Branch
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Mississippi
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38654
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Columbia
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Missouri
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65212
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United States
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Kansas City
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Missouri
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64111
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United States
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City
Kansas City
State/Province
Missouri
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64128
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United States
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City
Kansas City
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Missouri
ZIP/Postal Code
64151
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United States
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City
Bronx
State/Province
New York
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10455
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United States
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City
Rosedale
State/Province
New York
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11422
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United States
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Chapel Hill
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North Carolina
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27599
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United States
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New Bern
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North Carolina
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28562
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United States
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City
Toledo
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Ohio
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43614
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United States
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Grants Pass
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Oregon
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97527
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Bethlehem
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Pennsylvania
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18017
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Memphis
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38105
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Brownsville
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Texas
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78526
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United States
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Corpus Christi
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Texas
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78404
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United States
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Dallas
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Texas
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75390
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United States
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Houston
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Texas
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77054
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United States
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Sugar Land
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Texas
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77479
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United States
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Manassas
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Virginia
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20110
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Suffolk
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23435
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Madison
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53792
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United States
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Milwaukee
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53295
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Buenos Aires
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Argentina
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Caba
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Argentina
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Caba
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Argentina
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Cordoba
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X5003DCP
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Argentina
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Córdoba
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5000
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Argentina
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Mar del Plata
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B7600
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Argentina
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San Miguel de Tucuman
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4000
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Argentina
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San Nicolás
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B2900DMH
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Argentina
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San Vicente
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5006
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Argentina
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Clayton
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3168
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Australia
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Epping
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3076
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Australia
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Perth
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6000
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Australia
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Wollongong
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2500
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Australia
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Braunau am Inn
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Austria
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St. Pölten
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Wien
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1090
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Aalst
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Belgium
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Genk
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3600
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Belgium
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Gent
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9000
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Belgium
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Leuven
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3000
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Belgium
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Liège
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4000
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Belgium
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Mons
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7000
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Belgium
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Pleven
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5800
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Bulgaria
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Sofia
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1527
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Bulgaria
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Sofia
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1618
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Bulgaria
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Sofia
ZIP/Postal Code
1680
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Bulgaria
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City
Sofia
ZIP/Postal Code
1709
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Bulgaria
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North Vancouver
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British Columbia
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V7M 2H4
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Canada
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Cambridge
State/Province
Ontario
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N1R 6V6
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Canada
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Toronto
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Ontario
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M6G 1M2
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Canada
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Waterloo
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Ontario
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Canada
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Chicoutimi
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Quebec
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Canada
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St Jean sur Richelieu
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Quebec
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Canada
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Benesov
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Czechia
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Brandys nad Labem
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Czechia
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Broumov
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55001
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Czechia
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Louny
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440 01
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Czechia
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City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Research Site
City
Pribram
ZIP/Postal Code
261 01
Country
Czechia
Facility Name
Research Site
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Research Site
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Research Site
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Research Site
City
Holbæk
ZIP/Postal Code
4300
Country
Denmark
Facility Name
Research Site
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Research Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Research Site
City
Paris Cedex 14
ZIP/Postal Code
75013
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Research Site
City
Sr Priest En Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Research Site
City
Toulon
ZIP/Postal Code
83100
Country
France
Facility Name
Research Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Research Site
City
Bad Homburg
ZIP/Postal Code
61348
Country
Germany
Facility Name
Research Site
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Research Site
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Research Site
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Research Site
City
Elsterwerda
ZIP/Postal Code
04910
Country
Germany
Facility Name
Research Site
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Research Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Research Site
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Research Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Research Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30449
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Research Site
City
Homburg
ZIP/Postal Code
66424
Country
Germany
Facility Name
Research Site
City
Kaiserslautern
ZIP/Postal Code
67655
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Research Site
City
Lübeck
ZIP/Postal Code
23562
Country
Germany
Facility Name
Research Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Research Site
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Research Site
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Research Site
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Research Site
City
Wermsdorf
ZIP/Postal Code
04779
Country
Germany
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Research Site
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Research Site
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Research Site
City
Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Research Site
City
Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Research Site
City
Guntur
ZIP/Postal Code
522001
Country
India
Facility Name
Research Site
City
Hyderabad
ZIP/Postal Code
500032
Country
India
Facility Name
Research Site
City
Jaipur
ZIP/Postal Code
302004
Country
India
Facility Name
Research Site
City
Kanpur
ZIP/Postal Code
208002
Country
India
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700014
Country
India
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700020
Country
India
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700053
Country
India
Facility Name
Research Site
City
Manipal
ZIP/Postal Code
576104
Country
India
Facility Name
Research Site
City
Mysuru
ZIP/Postal Code
570004
Country
India
Facility Name
Research Site
City
Mysuru
ZIP/Postal Code
570015
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Research Site
City
Puducherry
ZIP/Postal Code
605006
Country
India
Facility Name
Research Site
City
Pune
ZIP/Postal Code
411013
Country
India
Facility Name
Research Site
City
Surat
ZIP/Postal Code
395001
Country
India
Facility Name
Research Site
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Research Site
City
petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Research Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Research Site
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Research Site
City
Acquaviva delle Fonti
ZIP/Postal Code
70021
Country
Italy
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Research Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20138
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20149
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Research Site
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Research Site
City
Bucheon-si
ZIP/Postal Code
420-717
Country
Korea, Republic of
Facility Name
Research Site
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
02841
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
04763
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
07441
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
07804
Country
Korea, Republic of
Facility Name
Research Site
City
Kajang
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
Research Site
City
Kota Bahru
ZIP/Postal Code
15586
Country
Malaysia
Facility Name
Research Site
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Research Site
City
Melaka
ZIP/Postal Code
75400
Country
Malaysia
Facility Name
Research Site
City
Muar
ZIP/Postal Code
84000
Country
Malaysia
Facility Name
Research Site
City
Sarawak Miri
ZIP/Postal Code
98000
Country
Malaysia
Facility Name
Research Site
City
Seri Manjung
ZIP/Postal Code
32040
Country
Malaysia
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1100 DD
Country
Netherlands
Facility Name
Research Site
City
Hoogeveen
ZIP/Postal Code
7909 AA
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Research Site
City
Utrecht
ZIP/Postal Code
3508 AB
Country
Netherlands
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-095
Country
Poland
Facility Name
Research Site
City
Chrzanów
ZIP/Postal Code
32-500
Country
Poland
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Research Site
City
Gdynia
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
91-002
Country
Poland
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-172
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-758
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
85101
Country
Slovakia
Facility Name
Research Site
City
Brezno
ZIP/Postal Code
977 01
Country
Slovakia
Facility Name
Research Site
City
Kosice
ZIP/Postal Code
04022
Country
Slovakia
Facility Name
Research Site
City
Moldava nad Bodvou
ZIP/Postal Code
04501
Country
Slovakia
Facility Name
Research Site
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Research Site
City
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
Research Site
City
Svidník
ZIP/Postal Code
08901
Country
Slovakia
Facility Name
Research Site
City
Trnava
ZIP/Postal Code
91701
Country
Slovakia
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Research Site
City
Centurion
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Research Site
City
Claremont
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Research Site
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Research Site
City
Kwadwesi
ZIP/Postal Code
6201
Country
South Africa
Facility Name
Research Site
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Research Site
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Ferrol
ZIP/Postal Code
15401
Country
Spain
Facility Name
Research Site
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Majadahonda
ZIP/Postal Code
28250
Country
Spain
Facility Name
Research Site
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Research Site
City
Terrassa
ZIP/Postal Code
08021
Country
Spain
Facility Name
Research Site
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
SE-18288
Country
Sweden
Facility Name
Research Site
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Research Site
City
Yung Kang City
ZIP/Postal Code
71044
Country
Taiwan
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Research Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Research Site
City
Muang
ZIP/Postal Code
22000
Country
Thailand
Facility Name
Research Site
City
Muang
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Research Site
City
Pathumthani
ZIP/Postal Code
12120
Country
Thailand
Facility Name
Research Site
City
Adana
ZIP/Postal Code
01060
Country
Turkey
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Research Site
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Research Site
City
Dinar
ZIP/Postal Code
03400
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34862
Country
Turkey
Facility Name
Research Site
City
Izmir
Country
Turkey
Facility Name
Research Site
City
Kütahya
ZIP/Postal Code
43100
Country
Turkey
Facility Name
Research Site
City
Odunpazarı
ZIP/Postal Code
26080
Country
Turkey
Facility Name
Research Site
City
Bristol
ZIP/Postal Code
BS34 6BQ
Country
United Kingdom
Facility Name
Research Site
City
Chesterfield
ZIP/Postal Code
S40 4AA
Country
United Kingdom
Facility Name
Research Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
Research Site
City
Prescot
ZIP/Postal Code
L35 5DR
Country
United Kingdom
Facility Name
Research Site
City
Stockport
Country
United Kingdom
Facility Name
Research Site
City
Yate
ZIP/Postal Code
BS37 4AX
Country
United Kingdom
Facility Name
Research Site
City
Da Nang
ZIP/Postal Code
550000
Country
Vietnam
Facility Name
Research Site
City
Ha Noi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
70000
Country
Vietnam
Facility Name
Research Site
City
Hochiminh city
ZIP/Postal Code
700000
Country
Vietnam
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 Vivli.org. All requests 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 approved.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer 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 anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD Sharing URL
https://vivli.org/
Learn more about this trial
A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
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