Trials / Completed
CompletedNCT01375777
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
A Randomized, Placebo- and Ezetimibe-controlled, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Hypercholesterolemic Subjects With a 10-year Framingham Risk Score of 10% or Less
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 411 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Evolocumab | Administered by subcutaneous injection |
| DRUG | Ezetimibe | Administered orally once a day |
| OTHER | Placebo to Evolocumab | Administered by subcutaneous injection |
Timeline
- Start date
- 2011-07-06
- Primary completion
- 2012-03-02
- Completion
- 2012-03-02
- First posted
- 2011-06-17
- Last updated
- 2022-11-08
- Results posted
- 2015-10-05
Locations
58 sites across 5 countries: United States, Australia, Belgium, Canada, Denmark
Source: ClinicalTrials.gov record NCT01375777. Inclusion in this directory is not an endorsement.