Trials / Completed
CompletedNCT01763918
Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Subjects With Heterozygous Familial Hypercholesterolemia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 331 (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 evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Evolocumab | Administered by subcutaneous injection |
| DRUG | Placebo | Administered by subcutaneous injection |
Timeline
- Start date
- 2013-02-07
- Primary completion
- 2013-11-27
- Completion
- 2013-12-19
- First posted
- 2013-01-09
- Last updated
- 2019-06-17
- Results posted
- 2015-12-22
Locations
39 sites across 14 countries: United States, Australia, Canada, France, Germany, Hong Kong, Netherlands, New Zealand, Norway, South Africa, Spain, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01763918. Inclusion in this directory is not an endorsement.