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Trial · NCT03317002

AZD5718 Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 in Patients With Coronary Artery Disease (CAD).

NCT03317002, Phase 2, Completed, AstraZeneca; results first posted 2021-06-30

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. AZD5718 Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 in Patients With Coronary Artery Disease (CAD). Trials, record NCT03317002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03317002

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
AZD5718 Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 in Patients With Coronary Artery Disease (CAD).
NCT number
NCT03317002
Status
Completed
Phases
Phase 2
Enrollment
129 participants, actual
Lead sponsor
AstraZeneca
Conditions
Coronary Artery Disease
Interventions
AZD5718, AZD5718, Placebo
First posted
2017-10-23
Last updated
2021-06-30
Results first posted
2021-06-30

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange From Baseline in Creatinine-normalized u-LTE4 at Week 4Baseline and 4 weeksCreatinine-normalized u-LTE4 is calculated as uLTE4/creatinine
SecondaryChange From Baseline in Creatinine-normalized u-LTE4 at Week 12Baseline and 12 weeksCreatinine-normalized u-LTE4 is calculated as uLTE4/creatinine
SecondaryChange From Baseline in CFVR at Week 12Baseline and 12 weeksCFVR = Coronary Flow Velocity Reserve = LAD(hyperaemic)/LAD(rest)
SecondaryChange From Baseline in CFVR at Week 4Baseline and 4 weeksCFVR = Coronary Flow Velocity Reserve = LAD(hyperaemic)/LAD(rest)
SecondarySummary of Plasma Concentrations of AZD571816 weeks
SecondaryChange From Baseline in LAD Hypereamic Flow at 4 WeeksBaseline and 4 weeksLAD=Left Anterior Descending
SecondaryChange From Baseline in LVEF at 4 WeeksBaseline and 4 weeksLVEF=Left Ventricular Ejection Fraction
SecondaryChange From Baseline in LV Longitudinal Early Diastolic Strain Rate at 4 WeeksBaseline and 4 weeksLV=Left Ventricular
SecondaryChange From Baseline in LV-GLS at Rest at Week 4Baseline and 4 weeksLV-GLS = Left Ventricular Global Longitudinal Strain
SecondaryChange From Baseline in LV-GCS at Rest at Week 4Baseline and 4 weeksLV-GCS = Left Ventricular Global Circumferential Strain

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in Creatinine-normalized u-LTE4 at Week 4Baseline and 4 weeksNumber of participants analysed differs from participant flow module due to missing dataRatioGEOMETRIC_MEAN
SECONDARYChange From Baseline in Creatinine-normalized u-LTE4 at Week 12Baseline and 12 weeksNumber of participants analysed differs from participant flow module due to missing dataRatioGEOMETRIC_MEAN
SECONDARYChange From Baseline in CFVR at Week 12Baseline and 12 weeksNumber of participants analysed differs from participant flow module due to missing dataRatioGEOMETRIC_MEAN
SECONDARYChange From Baseline in CFVR at Week 4Baseline and 4 weeksNumber of participants analysed differs from participant flow module due to missing dataRatioGEOMETRIC_MEAN
SECONDARYSummary of Plasma Concentrations of AZD571816 weeksNumber of participants analysed differs from participant flow module due to missing datanmol/LGEOMETRIC_MEAN
SECONDARYChange From Baseline in LAD Hypereamic Flow at 4 WeeksBaseline and 4 weeksNumber of participants analysed differs from participant flow module due to missing datam/secMEAN
SECONDARYChange From Baseline in LVEF at 4 WeeksBaseline and 4 weeksNumber of participants analysed differs from participant flow module due to missing datapercent LVEFMEAN
SECONDARYChange From Baseline in LV Longitudinal Early Diastolic Strain Rate at 4 WeeksBaseline and 4 weeksNumber of participants analysed differs from participant flow module due to missing data1/sGEOMETRIC_MEAN
SECONDARYChange From Baseline in LV-GLS at Rest at Week 4Baseline and 4 weeksNumber of participants analysed differs from participant flow module due to missing dataPercent LV-GLSMEAN
SECONDARYChange From Baseline in LV-GCS at Rest at Week 4Baseline and 4 weeksNumber of participants analysed differs from participant flow module due to missing dataPercentMEAN

Results by group46

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change From Baseline in Creatinine-normalized u-LTE4 at Week 4AZD5718 (200 mg)0.04Geometric Coefficient of Variation 92.55Ratio
Change From Baseline in Creatinine-normalized u-LTE4 at Week 4AZD5718 (50 mg)0.09Geometric Coefficient of Variation 84.32Ratio
Change From Baseline in Creatinine-normalized u-LTE4 at Week 4Placebo1.09Geometric Coefficient of Variation 44.38Ratio
Change From Baseline in Creatinine-normalized u-LTE4 at Week 12AZD5718 (200 mg)0.04Geometric Coefficient of Variation 92.55Ratio
Change From Baseline in Creatinine-normalized u-LTE4 at Week 12AZD5718 (50 mg)0.09Geometric Coefficient of Variation 84.32Ratio
Change From Baseline in Creatinine-normalized u-LTE4 at Week 12Placebo1.09Geometric Coefficient of Variation 44.38Ratio
Change From Baseline in CFVR at Week 12AZD5718 (200 mg)0.93Geometric Coefficient of Variation 23.64Ratio
Change From Baseline in CFVR at Week 12AZD5718 (50 mg)0.98Geometric Coefficient of Variation 39.53Ratio
Change From Baseline in CFVR at Week 12Placebo1.16Geometric Coefficient of Variation 33.46Ratio
Change From Baseline in CFVR at Week 4AZD5718 (200 mg)1.03Geometric Coefficient of Variation 28.34Ratio

Participant flow9

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDAZD5718 (200 mg)52
Overall StudySTARTEDAZD5718 (50 mg)25
Overall StudySTARTEDPlacebo52
Overall StudyCOMPLETEDAZD5718 (200 mg)50
Overall StudyCOMPLETEDAZD5718 (50 mg)24
Overall StudyCOMPLETEDPlacebo51
Overall StudyNOT COMPLETEDAZD5718 (200 mg)2
Overall StudyNOT COMPLETEDAZD5718 (50 mg)1
Overall StudyNOT COMPLETEDPlacebo1

Adverse events75

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherNasopharyngitisInfections and infestationsAZD5718 (200 mg)652
otherNasopharyngitisInfections and infestationsAZD5718 (50 mg)425
otherNasopharyngitisInfections and infestationsPlacebo751
otherAnaemiaBlood and lymphatic system disordersAZD5718 (200 mg)452
otherAnaemiaBlood and lymphatic system disordersAZD5718 (50 mg)025
otherAnaemiaBlood and lymphatic system disordersPlacebo251
otherDyspnoeaRespiratory, thoracic and mediastinal disordersAZD5718 (200 mg)652
otherDyspnoeaRespiratory, thoracic and mediastinal disordersAZD5718 (50 mg)425
otherDyspnoeaRespiratory, thoracic and mediastinal disordersPlacebo751
otherCoughRespiratory, thoracic and mediastinal disordersAZD5718 (200 mg)552

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityAZD5718 (200 mg)052
Total, all-cause mortalityAZD5718 (50 mg)025
Total, all-cause mortalityPlacebo051
Total, other adverse eventsAZD5718 (200 mg)2752
Total, other adverse eventsAZD5718 (50 mg)1225
Total, other adverse eventsPlacebo2251
Total, serious adverse eventsAZD5718 (200 mg)452
Total, serious adverse eventsAZD5718 (50 mg)325
Total, serious adverse eventsPlacebo451

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
35842004DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03317002

GET https://conductscience.org/api/trials/v1/NCT03317002/results?page=2