deltatrials
Terminated PHASE2 INTERVENTIONAL 2-arm NCT01332331

Efficacy and Safety of Ambrisentan in Children 8-18yrs

A Randomized, Open Label Study Comparing Safety and Efficacy Parameters for a High and a Low Dose of Ambrisentan (Adjusted for Body Weight) for the Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years

Sponsor: GlaxoSmithKline

Updated 13 times since 2017 Last updated: Sep 19, 2019 Started: Jan 4, 2011 Primary completion: Nov 12, 2013 Completion: Nov 12, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Ongoing juvenile rat toxicology studies.

A PHASE2 clinical study on Hypertension, Pulmonary, this trial is terminated or withdrawn. The trial is conducted by GlaxoSmithKline and has accumulated 13 data snapshots since 2011. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~Mar 2018 · 11 months · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Nov 2018 · 4 months · monthly snapshot~Nov 2018 – ~Aug 2019 · 9 months · monthly snapshot~Aug 2019 – ~Nov 2019 · 3 months · monthly snapshot~Nov 2019 – ~Jan 2021 · 14 months · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 11 months · monthly snapshot

Change History

13 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE2

  5. Nov 2019 — Jan 2021 [monthly]

    Terminated PHASE2

Show 8 earlier versions
  1. Aug 2019 — Nov 2019 [monthly]

    Terminated PHASE2

    Status: SuspendedTerminated

  2. Nov 2018 — Aug 2019 [monthly]

    Suspended PHASE2

  3. Jul 2018 — Nov 2018 [monthly]

    Suspended PHASE2

  4. Jun 2018 — Jul 2018 [monthly]

    Suspended PHASE2

  5. Mar 2018 — Jun 2018 [monthly]

    Suspended PHASE2

  6. Apr 2017 — Mar 2018 [monthly]

    Suspended PHASE2

  7. Feb 2017 — Apr 2017 [monthly]

    Suspended PHASE2

  8. Jan 2017 — Feb 2017 [monthly]

    Suspended PHASE2

    First recorded

Jan 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • GlaxoSmithKline
Data source: GlaxoSmithKline

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