deltatrials
Completed PHASE2/PHASE3 NCT01588496

Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities

2-part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia

Sponsor: Amgen

Conditions Homozygous Familial Hypercholesterolemia
Interventions Evolocumab Placebo
Updated 11 times since 2017 Last updated: Nov 1, 2018 Started: Apr 5, 2012 Primary completion: Jan 31, 2014 Completion: Jan 31, 2014

Listed as NCT01588496, this PHASE2/PHASE3 trial focuses on Homozygous Familial Hypercholesterolemia and remains completed. Sponsored by Amgen, it has been updated 11 times since 2012, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Change History

11 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2/PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2/PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2/PHASE3

    Phase: PHASE2_PHASE3 → PHASE2/PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2_PHASE3

  5. Dec 2018 — Jan 2021 [monthly]

    Completed PHASE2_PHASE3

▶ Show 6 earlier versions

  1. Nov 2018 — Dec 2018 [monthly]

    Completed PHASE2_PHASE3

  2. Oct 2018 — Nov 2018 [monthly]

    Completed PHASE2_PHASE3

  3. Jun 2018 — Oct 2018 [monthly]

    Completed PHASE2_PHASE3

  4. May 2017 — Jun 2018 [monthly]

    Completed PHASE2_PHASE3

  5. Feb 2017 — May 2017 [monthly]

    Completed PHASE2_PHASE3

  6. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2_PHASE3

    First recorded

Apr 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Amgen
Data source: Amgen

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Amsterdam, Netherlands, Beirut, Lebanon, Brno, Czechia, Brussels, Belgium, Chicoutimi, Canada, Christchurch, New Zealand, Cincinnati, United States, Córdoba, Spain, Dijon, France, Hradec Králové, Czechia and 11 more location s