Phase 2
N=1,324
Open Label Study of Long Term Evaluation Against LDL-C Trial
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT01439880 ↗Enrolled (actual)
1,324
Serious AEs
16.5%
Results posted
Jul 2019
Primary outcome: Primary: Number of Participants With Adverse Events — 327; 728; 342; 718 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Evolocumab (Biological); Standard of care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
327; 728; 342; 718; 46; 99 | — |
| SECONDARY Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 |
144.6; 139.7; 147.7; 139.5; 143.4; 139.8 | — |
| SECONDARY Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 |
170.7; 165.1; 173.8; 165.5; 169.6; 165.0 | — |
| SECONDARY Apolipoprotein B Level at Week 24 and Week 52 |
113.2; 110.4; 115.4; 110.3; 112.4; 110.4 | — |
| SECONDARY Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 |
4.516; 4.386; 4.458; 4.388; 4.538; 4.386 | — |
| SECONDARY Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 |
0.759; 0.739; 0.764; 0.735; 0.757; 0.741 | — |
Summary
The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.
Eligibility Criteria
Inclusion Criteria
- Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703)
Exclusion Criteria
- Experienced a treatment-related serious adverse event that led to investigational product (IP) discontinuation in the parent study
- Have an unstable medical condition, in the judgment of the investigator
- Known sensitivity to any of the products to be administered during dosing
- Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)
Data sourced from ClinicalTrials.gov (NCT01439880). 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.