Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02304484
• Date of registration: 07/10/2014
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
• Scientific title: A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab
• Date of first enrolment: November 24, 2014
• Target sample size: 770
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02304484
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Czechia, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, Norway, Poland, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Completed week 80 of study 20120153 (NCT01813422).

Exclusion Criteria:

- Did not complete investigational product in the 20120153 parent study

- Have an unstable medical condition, in the judgment of the investigator

- Known sensitivity to any of the products to be administered during dosing

- Currently enrolled in another investigational device or drug study (excluding
evolocumab (AMG 145) parent study), or less than 30 days since ending another
investigational device or drug study(s),or receiving other investigational agent(s)



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypercholesterolemia

Intervention(s)

Biological: Evolocumab

Primary Outcome(s)

Number of Participants With Adverse Events [Time Frame: From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks.]

Secondary Outcome(s)

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) [Time Frame: Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128]

Secondary ID(s)

20140128

2014-001524-30

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02304484