Multicenter, Controlled, Open-Label Extension (OLE) Study To Assess the Long-Term Safety and Efficacy of AMG 145 (study 20110110)

Multicenter, Controlled, Open-Label Extension (OLE) Study To Assess the Long-Term Safety and Efficacy of AMG 145 (study 20110110) - AMG20110110 (OSLER)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40037

Enrollment

Registered

2011-10-10

Start date

2012-01-19

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

hypercholesterolaemia

Interventions

Treatment with AMG 145.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Completed a qualifying AMG 145 parent study protocol.

Exclusion criteria

Exclusion criteria: * Experienced a treatment-related serious adverse event in the parent study with AMG 145. * Pregnancy, inadequate contraception, breast feeding.

Design outcomes

Primary

Measure	Time frame
Adverse events.	—

Secondary

Measure	Time frame
LDL-C, non-HDL-C, ApoB, total cholesterol/HDL-C ratio, ApoB/Apo A1 ratio in week 24 and 52.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)