Trials / Completed
CompletedNCT01380730
LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
LAPLACE TIMI 57 - A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With HMG-CoA Reductase Inhibitors in Hypercholesterolemic Subjects
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 631 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Evolocumab | Administered by subcutaneous injection |
| OTHER | Placebo to Evolocumab | Administered by subcutaneous injection |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2012-04-05
- Completion
- 2012-04-05
- First posted
- 2011-06-27
- Last updated
- 2022-11-15
- Results posted
- 2015-10-01
Locations
100 sites across 5 countries: United States, Canada, Czechia, Denmark, Hungary
Source: ClinicalTrials.gov record NCT01380730. Inclusion in this directory is not an endorsement.