A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145

A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145 - OSLER 2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45229

Enrollment

146

Registered

2013-06-17

Start date

2013-08-15

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dyslipidemia

Interventions

Treatment with AMG 145.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subjects will be eligible for the study if they complete a qualifying AMG 145 parent study protocol while still on assigned study medication.

Exclusion criteria

Exclusion criteria: Subjects will be ineligible for the study if they fulfill any of the following criteria: 1. Discontinued assigned study drug during the qualifying study for any reason including an adverse event or serious adverse event. 2. Female subject is not willing to use an acceptable method(s) of effective birth control during treatment with investigational product (IP) and for an additional 15 weeks after the end of treatment with IP. Female subjects, who have had a hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or who are postmenopausal, are not required to use contraception o Menopause is defined as 12 months of spontaneous and continuous amenorrhea in a female * 55 years old; or age 40 IU/L) or postmenopausal estradiol levels (

Design outcomes

Primary

Measure	Time frame
Adverse events.	—

Secondary

Measure	Time frame
LDL-C at week 48 and 104.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)