Safety and Tolerability Study of AZD4831 in Patients With Heart Failure. (SATELLITE)
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|ClinicalTrials.gov Identifier: NCT03756285|
Recruitment Status : Suspended (Study put on hold by sponsor due to current pandemic situation)
First Posted : November 28, 2018
Last Update Posted : May 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: AZD4831 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicentre, Phase 2a Study to Assess Target Engagement, Safety and Tolerability of AZD4831 in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)|
|Actual Study Start Date :||December 11, 2018|
|Estimated Primary Completion Date :||October 13, 2020|
|Estimated Study Completion Date :||October 13, 2020|
AZD4831 tablets taken orally for for 90 days.
AZD4831 tablet taken orally for 90 days.
Placebo Comparator: Placebo
Placebo tablets taken orally for 90 days.
Placebo tablet taken orally for 90 days.
- The change from baseline in MPO activity in % after AZD4831 treatment. [ Time Frame: Measurements on day 0, 10, 30 and 90. ]To compare the effect of AZD4831 to placebo on target engagement
- Change from baseline in CFVR measured in the mid-distal segment of the left anterior descending (LAD) coronary artery under adenosine infusion measured by Transthoracic Doppler Echocardiography (TDE). [ Time Frame: Measurement on day 0 and 90. ]To compare the effect of AZD4831 to placebo on coronary flow velocity reserve (CFVR)
- Change from baseline in Walking distance [ Time Frame: Measurement on day 0, 30 and 90. ]To compare the effect of AZD4831 to placebo on 6 minutes walking test (6MWT)
- The pharmacokinetic assessment parameter to be reported is AUC [ Time Frame: Measurement on day 10, 20, 30, 60, 90 and 120. ]To assess the pharmacokinetics of AZD4831 after repeated dosing
- The Pharmacokinetic assessment parameter to be reported is CL/F. [ Time Frame: Measurment on day 10, 20, 30, 60, 90 and 120. ]To assess the pharmatokinetics of AZD4831 after repeated dosing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03756285
|United States, Alabama|
|Fort Payne, Alabama, United States, 35967|
|United States, Georgia|
|Tucker, Georgia, United States, 30084|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Hazel Crest, Illinois, United States, 60429|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|Aarhus N, Denmark, 8200|
|Herlev, Denmark, 2730|
|Hvidovre, Denmark, 2650|
|Odense C, Denmark, 5000|
|Turku, Finland, 20520|
|Deventer, Netherlands, 7416 SE|
|Dordrecht, Netherlands, 3318 AT|
|Groningen, Netherlands, 9713 GZ|
|Göteborg, Sweden, 41345|
|Lund, Sweden, 22242|
|Stockholm, Sweden, 171 76|