Phase 2
N=132
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease
Stable Coronary Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT03351738 ↗Enrolled (actual)
132
Serious AEs
6.8%
Results posted
Dec 2019
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) — 17; 10; 11; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MEDI5884 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
17; 10; 11; 12; 13; 13 | — |
| PRIMARY Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Important Changes in Vital Signs From Baseline |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Important Changes in Physical Examinations From Baseline |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Apolipoprotein B |
3.3; 0.5; 5.1; 2.2; 7.1; 7.1 | — |
| SECONDARY Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) |
-3.08; 7.37; 22.95; 27.25; 44.12; 55.80 | — |
| SECONDARY Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884 |
14.6; 51.8; 191; 584; 1020 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose |
1.01; 4.63; 11.9; 28.5; 46.3 | — |
| SECONDARY Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose |
7.56; 8.09; 10.3; 13.7 | — |
| SECONDARY Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884 |
1; 1; 1; 3; 3; 3 | — |
Summary
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of stable coronary heart disease prior to screening
- Currently receiving high intensity statin(s)
Exclusion Criteria
- Unstable cardiovascular conditions
- Any planned arterial revascularizations
- Fasting Laboratory values at screening: Triglycerides > 500 mg/dl, Low Density Lipoprotein-Cholesterol > 100 mg/dL
- Any disease or condition or laboratory value that would place the participant at an unacceptable risk.
Data sourced from ClinicalTrials.gov (NCT03351738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.