Trials / Completed
CompletedNCT01763905
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 307 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Evolocumab | Subcutaneous injection |
| DRUG | Placebo to Evolocumab | Subcutaneous injection |
| DRUG | Ezetimibe | Tablet for oral administration |
| DRUG | Placebo to Ezetimibe | Tablet for oral administration |
Timeline
- Start date
- 2013-01-24
- Primary completion
- 2013-11-19
- Completion
- 2013-11-19
- First posted
- 2013-01-09
- Last updated
- 2020-07-20
- Results posted
- 2015-12-22
Locations
58 sites across 14 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Netherlands, Poland, South Africa, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01763905. Inclusion in this directory is not an endorsement.