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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Creatinine-normalized u-LTE4 at Week 4 | Baseline and 4 weeks | Creatinine-normalized u-LTE4 is calculated as uLTE4/creatinine |
| Secondary | Change From Baseline in Creatinine-normalized u-LTE4 at Week 12 | Baseline and 12 weeks | Creatinine-normalized u-LTE4 is calculated as uLTE4/creatinine |
| Secondary | Change From Baseline in CFVR at Week 12 | Baseline and 12 weeks | CFVR = Coronary Flow Velocity Reserve = LAD(hyperaemic)/LAD(rest) |
| Secondary | Change From Baseline in CFVR at Week 4 | Baseline and 4 weeks | CFVR = Coronary Flow Velocity Reserve = LAD(hyperaemic)/LAD(rest) |
| Secondary | Summary of Plasma Concentrations of AZD5718 | 16 weeks | |
| Secondary | Change From Baseline in LAD Hypereamic Flow at 4 Weeks | Baseline and 4 weeks | LAD=Left Anterior Descending |
| Secondary | Change From Baseline in LVEF at 4 Weeks | Baseline and 4 weeks | LVEF=Left Ventricular Ejection Fraction |
| Secondary | Change From Baseline in LV Longitudinal Early Diastolic Strain Rate at 4 Weeks | Baseline and 4 weeks | LV=Left Ventricular |
| Secondary | Change From Baseline in LV-GLS at Rest at Week 4 | Baseline and 4 weeks | LV-GLS = Left Ventricular Global Longitudinal Strain |
| Secondary | Change From Baseline in LV-GCS at Rest at Week 4 | Baseline and 4 weeks | LV-GCS = Left Ventricular Global Circumferential Strain |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Creatinine-normalized u-LTE4 at Week 4 | Baseline and 4 weeks | Number of participants analysed differs from participant flow module due to missing data | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Creatinine-normalized u-LTE4 at Week 12 | Baseline and 12 weeks | Number of participants analysed differs from participant flow module due to missing data | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in CFVR at Week 12 | Baseline and 12 weeks | Number of participants analysed differs from participant flow module due to missing data | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in CFVR at Week 4 | Baseline and 4 weeks | Number of participants analysed differs from participant flow module due to missing data | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Summary of Plasma Concentrations of AZD5718 | 16 weeks | Number of participants analysed differs from participant flow module due to missing data | nmol/L | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in LAD Hypereamic Flow at 4 Weeks | Baseline and 4 weeks | Number of participants analysed differs from participant flow module due to missing data | m/sec | MEAN |
| SECONDARY | Change From Baseline in LVEF at 4 Weeks | Baseline and 4 weeks | Number of participants analysed differs from participant flow module due to missing data | percent LVEF | MEAN |
| SECONDARY | Change From Baseline in LV Longitudinal Early Diastolic Strain Rate at 4 Weeks | Baseline and 4 weeks | Number of participants analysed differs from participant flow module due to missing data | 1/s | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in LV-GLS at Rest at Week 4 | Baseline and 4 weeks | Number of participants analysed differs from participant flow module due to missing data | Percent LV-GLS | MEAN |
| SECONDARY | Change From Baseline in LV-GCS at Rest at Week 4 | Baseline and 4 weeks | Number of participants analysed differs from participant flow module due to missing data | Percent | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Creatinine-normalized u-LTE4 at Week 4 | AZD5718 (200 mg) | 0.04 | Geometric Coefficient of Variation 92.55 | Ratio | |
| Change From Baseline in Creatinine-normalized u-LTE4 at Week 4 | AZD5718 (50 mg) | 0.09 | Geometric Coefficient of Variation 84.32 | Ratio | |
| Change From Baseline in Creatinine-normalized u-LTE4 at Week 4 | Placebo | 1.09 | Geometric Coefficient of Variation 44.38 | Ratio | |
| Change From Baseline in Creatinine-normalized u-LTE4 at Week 12 | AZD5718 (200 mg) | 0.04 | Geometric Coefficient of Variation 92.55 | Ratio | |
| Change From Baseline in Creatinine-normalized u-LTE4 at Week 12 | AZD5718 (50 mg) | 0.09 | Geometric Coefficient of Variation 84.32 | Ratio | |
| Change From Baseline in Creatinine-normalized u-LTE4 at Week 12 | Placebo | 1.09 | Geometric Coefficient of Variation 44.38 | Ratio | |
| Change From Baseline in CFVR at Week 12 | AZD5718 (200 mg) | 0.93 | Geometric Coefficient of Variation 23.64 | Ratio | |
| Change From Baseline in CFVR at Week 12 | AZD5718 (50 mg) | 0.98 | Geometric Coefficient of Variation 39.53 | Ratio | |
| Change From Baseline in CFVR at Week 12 | Placebo | 1.16 | Geometric Coefficient of Variation 33.46 | Ratio | |
| Change From Baseline in CFVR at Week 4 | AZD5718 (200 mg) | 1.03 | Geometric Coefficient of Variation 28.34 | Ratio |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZD5718 (200 mg) | 52 | |
| Overall Study | STARTED | AZD5718 (50 mg) | 25 | |
| Overall Study | STARTED | Placebo | 52 | |
| Overall Study | COMPLETED | AZD5718 (200 mg) | 50 | |
| Overall Study | COMPLETED | AZD5718 (50 mg) | 24 | |
| Overall Study | COMPLETED | Placebo | 51 | |
| Overall Study | NOT COMPLETED | AZD5718 (200 mg) | 2 | |
| Overall Study | NOT COMPLETED | AZD5718 (50 mg) | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events75
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | AZD5718 (200 mg) | 6 | 52 | |
| other | Nasopharyngitis | Infections and infestations | AZD5718 (50 mg) | 4 | 25 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 7 | 51 | |
| other | Anaemia | Blood and lymphatic system disorders | AZD5718 (200 mg) | 4 | 52 | |
| other | Anaemia | Blood and lymphatic system disorders | AZD5718 (50 mg) | 0 | 25 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 2 | 51 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | AZD5718 (200 mg) | 6 | 52 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | AZD5718 (50 mg) | 4 | 25 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Placebo | 7 | 51 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | AZD5718 (200 mg) | 5 | 52 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD5718 (200 mg) | 0 | 52 |
| Total, all-cause mortality | AZD5718 (50 mg) | 0 | 25 |
| Total, all-cause mortality | Placebo | 0 | 51 |
| Total, other adverse events | AZD5718 (200 mg) | 27 | 52 |
| Total, other adverse events | AZD5718 (50 mg) | 12 | 25 |
| Total, other adverse events | Placebo | 22 | 51 |
| Total, serious adverse events | AZD5718 (200 mg) | 4 | 52 |
| Total, serious adverse events | AZD5718 (50 mg) | 3 | 25 |
| Total, serious adverse events | Placebo | 4 | 51 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35842004 | DERIVED |
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.
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