Trials / Completed
CompletedNCT01375764
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
A Randomized, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (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), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.
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
- 2011-07-28
- Primary completion
- 2012-05-08
- Completion
- 2012-05-08
- First posted
- 2011-06-17
- Last updated
- 2022-11-07
- Results posted
- 2015-12-23
Locations
42 sites across 8 countries: United States, Australia, Belgium, Canada, Denmark, Finland, Spain, Sweden
Source: ClinicalTrials.gov record NCT01375764. Inclusion in this directory is not an endorsement.