A Phase 2 interventional study of MEDI5884 and Placebo in Stable Coronary Heart Disease, sponsored by MedImmune LLC. Completed at 23 sites in United States. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-03-23.
Sponsored by MedImmune LLC (part of AstraZeneca) · Phase 2, Interventional, and Treatment
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Among 18 studies in Coronary Disease by AstraZeneca — none open to participants now, none under way, none of them phase 3. Coronary Disease · AstraZeneca.
Among the 18 studies in Coronary Disease by AstraZeneca, this one is the only one that started in 2017, is one of 2 in phase 2, and was the 17th registered.
1,521 studies on the registry are indexed under Coronary Disease; 168 are open to participants now.
Browse Coronary Disease studies →None of the 18 studies in Coronary Disease by AstraZeneca is open now. The open studies under Coronary Disease, anywhere →
Of the 106 Coronary Disease studies recruiting now, 64 (60%) set no upper age limit and 19 (18%) stop at 75 or younger; 8 take children under 18; 10 take healthy volunteers.
This study: 45 Years to 80 Years · all sexes · no healthy volunteers.
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18 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 133 is below the median of 160 across 779 interventional studies indexed under Coronary Disease.
Median enrollment 339 across the 8 interventional studies, 1,096 across the 7 observational. Of the 17 that completed or were terminated, 5 (29%) have results posted.
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This study is registered under MedImmune LLC, one of the names counted as AstraZeneca. Under that name alone:
MedImmune LLC is the lead sponsor of 270 studies on the registry; none are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 29 (56%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 18 studies in Coronary Disease by AstraZeneca, from their registry updates:
Nothing recorded among them since 2026-09-25.
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A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease.
A Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Participants with Stable Coronary Heart Disease.
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Exclusion Criteria:
Participants will receive subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
Drug: Placebo
Participants will receive SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
Drug: MEDI5884
Participants will receive SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
Drug: MEDI5884
Participants will receive SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
Drug: MEDI5884
Participants will receive SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
Drug: MEDI5884
Participants will receive SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
Drug: MEDI5884
Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
Participants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time frame: Day 1 (Baseline) through Day 241
Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline
Number of participants with clinically important changes in ECGs from baseline are reported. Clinically important changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT intervals from the primary lead of the digital 12-lead ECG from baseline.
Time frame: Day 1 (Baseline) through Day 241
Number of Participants With Clinically Important Changes in Vital Signs From Baseline
Number of participants with clinically important changes in vital signs from baseline are reported. Vital signs measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Clinically important changes in vital signs from baseline is defined as any clinical significant difference in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate) from baseline.
Time frame: Day 1 (Baseline) through Day 241
Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline
Number of participants with clinically important changes in laboratory parameters from baseline are reported. Clinically important changes in laboratory parameters is defined as any clinical significant difference in analysis of serum chemistry, hematology, and urine from baseline.
Time frame: Day 1 (Baseline) through Day 241
Number of Participants With Clinically Important Changes in Physical Examinations From Baseline
Number of participants with clinically important changes in physical examinations from baseline are reported. Clinically important changes in physical examinations is defined as any clinical significant difference in general appearance, head, ears, eyes, nose, throat, neck, skin, heart, lung, abdomen, musculoskeletal system, endocrine system, nervous system, height, and weight from baseline.
Time frame: Day 1 (Baseline) through Day 241
Change From Baseline in Apolipoprotein B
Change from baseline in apolipoprotein B is reported.
Time frame: Day 1 (Baseline), and Days 31, 61, and 91
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)
Percent change from baseline in HDL-C is reported.
Time frame: Day 1 (Baseline), and Days 31, 61, and 91
Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884
AUC30d after the last dose of MEDI5884 is reported.
Time frame: Day 61 (pre-dose), and on Days 64, 68, 71, and 91
Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose
Maximum observed serum concentration (Cmax) of MEDI5884 after the last dose is reported.
Time frame: Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose
Terminal half-life is the time required for the plasma concentration to fall by 50% during the terminal phase. The t½ of MEDI5884 after the last dose is reported.
Time frame: Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884
Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post baseline-positive only) and treatment-boosted ADA (baseline ADA titer that was boosted to a 4-fold or higher level following drug administration).
Time frame: Day 1 (pre-dose), on Day 8, Day 31 (pre-dose), Day 61 (pre-dose), on Days 151 and 241
The study was conducted in the US between 13Dec2017 and 09Nov2018.
| Milestone | Placebo | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg |
|---|---|---|---|---|---|---|
| Started | 23 | 20 | 24 | 22 | 21 | 22 |
| Completed | 23 | 19 | 24 | 21 | 21 | 22 |
| Not completed | 0 | 1 | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 1 | 0 | 0 |
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
| Participants | Placebo | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg |
|---|---|---|---|---|---|---|
| TEAEs | 17 | 10 | 11 | 12 | 13 | 13 |
| TESAEs | 2 | 2 | 1 | 0 | 4 | 0 |
Number of participants with clinically important changes in ECGs from baseline are reported. Clinically important changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT intervals from the primary lead of the digital 12-lead ECG from baseline.
| Participants | Placebo | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg |
|---|---|---|---|---|---|---|
| Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline | 0 | 0 | 0 | 0 | 0 | 0 |
Number of participants with clinically important changes in vital signs from baseline are reported. Vital signs measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Clinically important changes in vital signs from baseline is defined as any clinical significant difference in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate) from baseline.
| Participants | Placebo | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg |
|---|---|---|---|---|---|---|
| Number of Participants With Clinically Important Changes in Vital Signs From Baseline | 0 | 0 | 0 | 0 | 0 | 0 |
Number of participants with clinically important changes in laboratory parameters from baseline are reported. Clinically important changes in laboratory parameters is defined as any clinical significant difference in analysis of serum chemistry, hematology, and urine from baseline.
| Participants | Placebo | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg |
|---|---|---|---|---|---|---|
| Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline | 0 | 0 | 0 | 0 | 0 | 0 |
Number of participants with clinically important changes in physical examinations from baseline are reported. Clinically important changes in physical examinations is defined as any clinical significant difference in general appearance, head, ears, eyes, nose, throat, neck, skin, heart, lung, abdomen, musculoskeletal system, endocrine system, nervous system, height, and weight from baseline.
| Participants | Placebo | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg |
|---|---|---|---|---|---|---|
| Number of Participants With Clinically Important Changes in Physical Examinations From Baseline | 0 | 0 | 0 | 0 | 0 | 0 |
Change from baseline in apolipoprotein B is reported.
| mg/dL | Placebo | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg |
|---|---|---|---|---|---|---|
| Day 31 | 3.3 ± 8.5 | 0.5 ± 12.2 | 5.1 ± 10.6 | 2.2 ± 9.4 | 7.1 ± 10.6 | 7.1 ± 14.3 |
| Day 61 | 1.2 ± 13.9 | -1.2 ± 14.1 | 3.5 ± 10.8 | 2.6 ± 15.3 | 3.7 ± 11.7 | 6.2 ± 9.6 |
| Day 91 | -0.5 ± 10.7 | 3.6 ± 29.3 | 2.3 ± 10.7 | 2.0 ± 8.3 | 2.9 ± 9.4 | 7.8 ± 13.4 |
Percent change from baseline in HDL-C is reported.
| Percent change | Placebo | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg |
|---|---|---|---|---|---|---|
| Day 31 | -3.08 ± 10.28 | 7.37 ± 13.52 | 22.95 ± 25.04 | 27.25 ± 19.37 | 44.12 ± 24.74 | 55.80 ± 25.97 |
| Day 61 | -4.69 ± 9.45 | 4.58 ± 12.45 | 28.28 ± 32.19 | 37.65 ± 22.76 | 39.74 ± 22.74 | 49.58 ± 21.46 |
| Day 91 | -3.62 ± 13.41 | 1.98 ± 14.69 | 21.82 ± 30.66 | 35.63 ± 35.27 | 43.29 ± 31.09 | 48.31 ± 25.63 |
AUC30d after the last dose of MEDI5884 is reported.
| μg⋅day/mL | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg |
|---|---|---|---|---|---|
| Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884 | 14.6 ± 27.3 | 51.8 ± 54.8 | 191 ± 176 | 584 ± 294 | 1020 ± 643 |
Maximum observed serum concentration (Cmax) of MEDI5884 after the last dose is reported.
| μg/mL | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg |
|---|---|---|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose | 1.01 ± 1.34 | 4.63 ± 2.95 | 11.9 ± 7.77 | 28.5 ± 13.0 | 46.3 ± 24.6 |
Terminal half-life is the time required for the plasma concentration to fall by 50% during the terminal phase. The t½ of MEDI5884 after the last dose is reported.
| Days | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg |
|---|---|---|---|---|---|
| Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose | — | 7.56 ± 6.4 | 8.09 ± 2.80 | 10.3 ± 3.53 | 13.7 ± 5.86 |
Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post baseline-positive only) and treatment-boosted ADA (baseline ADA titer that was boosted to a 4-fold or higher level following drug administration).
| Participants | Placebo | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg |
|---|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884 | 1 | 1 | 1 | 3 | 3 | 3 |
Collected over Day 1 through Day 241. Non-serious events are listed at a 4.3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/23 (0%) | 2/23 (8.7%) | 9/23 (39.1%) |
| MEDI5884 50 mg | 0/20 (0%) | 2/20 (10%) | 9/20 (45%) |
| MEDI5884 100 mg | 0/24 (0%) | 1/24 (4.2%) | 6/24 (25%) |
| MEDI5884 200 mg | 0/22 (0%) | 0/22 (0%) | 12/22 (54.5%) |
| MEDI5884 350 mg | 0/21 (0%) | 4/21 (19%) | 13/21 (61.9%) |
| MEDI5884 500 mg | 0/22 (0%) | 0/22 (0%) | 13/22 (59.1%) |
| Event | Placebo | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg |
|---|---|---|---|---|---|---|
| Angina unstableCardiac disorders | 0/23 | 1/20 | 1/24 | 0/22 | 2/21 | 0/22 |
| Acute myocardial infarctionCardiac disorders | 0/23 | 1/20 | 0/24 | 0/22 | 0/21 | 0/22 |
| Atrial fibrillationCardiac disorders | 0/23 | 0/20 | 0/24 | 0/22 | 1/21 | 0/22 |
| Myocardial infarctionCardiac disorders | 0/23 | 0/20 | 0/24 | 0/22 | 1/21 | 0/22 |
| Non-cardiac chest painGeneral disorders | 1/23 | 0/20 | 0/24 | 0/22 | 1/21 | 0/22 |
| Peripheral artery occlusionVascular disorders | 1/23 | 0/20 | 0/24 | 0/22 | 0/21 | 0/22 |
| Event | Placebo | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg |
|---|---|---|---|---|---|---|
| Injection site erythemaGeneral disorders | 2/23 | 0/20 | 1/24 | 3/22 | 4/21 | 0/22 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/23 | 2/20 | 0/24 | 0/22 | 0/21 | 0/22 |
| HypotensionVascular disorders | 1/23 | 2/20 | 0/24 | 0/22 | 0/21 | 0/22 |
| Infected dermal cystInfections and infestations | 0/23 | 0/20 | 0/24 | 0/22 | 2/21 | 0/22 |
| Urinary tract infectionInfections and infestations | 0/23 | 1/20 | 0/24 | 0/22 | 2/21 | 0/22 |
| ContusionInjury, poisoning and procedural complications | 0/23 | 0/20 | 0/24 | 0/22 | 2/21 | 0/22 |
| Muscle strainInjury, poisoning and procedural complications | 0/23 | 0/20 | 0/24 | 0/22 | 2/21 | 0/22 |
| Upper respiratory tract infectionInfections and infestations | 0/23 | 1/20 | 1/24 | 1/22 | 0/21 | 2/22 |
| Injection site bruisingGeneral disorders | 2/23 | 0/20 | 0/24 | 0/22 | 1/21 | 1/22 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 2/23 | 0/20 | 0/24 | 0/22 | 0/21 | 0/22 |
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.
| Age, Continuous(Years) | Placebo | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg | Total |
|---|---|---|---|---|---|---|---|
| Mean | 66.3 ± 8.4 | 63.8 ± 8.4 | 67.4 ± 5.7 | 64.7 ± 8.9 | 67.5 ± 7.8 | 67.6 ± 8.6 | 66.3 ± 8.0 |
| Sex: Female, Male(Participants) | Placebo | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg | Total |
|---|---|---|---|---|---|---|---|
| Female | 4 | 3 | 1 | 4 | 1 | 4 | 17 |
| Male | 19 | 17 | 23 | 18 | 20 | 18 | 115 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 2 | 0 | 1 | 1 | 7 |
| Not Hispanic or Latino | 21 | 19 | 22 | 22 | 20 | 21 | 125 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | MEDI5884 50 mg | MEDI5884 100 mg | MEDI5884 200 mg | MEDI5884 350 mg | MEDI5884 500 mg | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 0 | 0 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 0 | 0 | 0 | 0 | 2 |
| Black or African American | 1 | 1 | 1 | 2 | 1 | 2 | 8 |
| White | 21 | 17 | 23 | 20 | 20 | 19 | 120 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Nov 2018, 10 months.
Results were first posted in Dec 2019, 1 year 1 month after primary completion.
Of 19 phase 2 interventional studies under Coronary Disease, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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