deltatrials
Terminated PHASE1 INTERVENTIONAL 6-arm NCT00984113

Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment

An Open-label, Parallel-group Study to Determine the Single and Multiple Dose Pharmacokinetics of Elinogrel and Its Metabolite in Patients With Mild, Moderate, and Severe Renal Impairment Compared to Healthy Subjects

Sponsor: Novartis

Conditions Renal Impairment
Interventions Elinogrel
Updated 13 times since 2017 Last updated: Aug 3, 2023 Started: Sep 30, 2009 Primary completion: Dec 31, 2009 Completion: Dec 31, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

For administrative reasons. Enrollment was sufficient to have statistical power without compromising the integrity of the study data

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Listed as NCT00984113, this PHASE1 trial focuses on Renal Impairment and remains terminated or withdrawn. Sponsored by Novartis, it has been updated 13 times since 2009, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~May 2018 · 9 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~Nov 2020 · 25 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Sep 2023 · 21 months · monthly snapshot~Sep 2023 – ~Dec 2023 · 3 months · monthly snapshot~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 23 months · monthly snapshot

Change History

13 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1

  3. Dec 2023 — Jul 2024 [monthly]

    Terminated PHASE1

  4. Sep 2023 — Dec 2023 [monthly]

    Terminated PHASE1

  5. Dec 2021 — Sep 2023 [monthly]

    Terminated PHASE1

▶ Show 8 earlier versions

  1. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE1

  2. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE1

  3. Oct 2018 — Nov 2020 [monthly]

    Terminated PHASE1

  4. Jun 2018 — Oct 2018 [monthly]

    Terminated PHASE1

  5. May 2018 — Jun 2018 [monthly]

    Terminated PHASE1

  6. Aug 2017 — May 2018 [monthly]

    Terminated PHASE1

  7. Feb 2017 — Aug 2017 [monthly]

    Terminated PHASE1

  8. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE1

    First recorded

Sep 2009

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis
  • Portola Pharmaceuticals
Data source: Alexion Pharmaceuticals, Inc.

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

Study Locations