deltatrials
Completed PHASE4 INTERVENTIONAL 1-arm NCT00678743

An Open-label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin

An Open-label Extension of a Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate Simvastatin 20 mg Plus Omacor 4g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia

Sponsor: Provident Clinical Research

Conditions Dyslipidemias
Updated 7 times since 2017 Last updated: May 27, 2025 Started: Aug 31, 2007 Primary completion: Aug 31, 2009 Completion: Sep 30, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00678743, this PHASE4 trial focuses on Dyslipidemias and remains completed. Sponsored by Provident Clinical Research, it has been updated 7 times since 2007, reflecting limited 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 snapshotUnknown Status~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Jun 2025 · 9 months · monthly snapshotUnknown~Jun 2025 – present · 13 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jun 2025 — Present [monthly]

    Completed PHASE4

    Status: UnknownCompleted

  2. Sep 2024 — Jun 2025 [monthly]

    Unknown PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE4

    Status: Unknown StatusUnknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status PHASE4

  5. Jun 2018 — Jan 2021 [monthly]

    Unknown Status PHASE4

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Unknown Status PHASE4

  2. Jan 2017 — Feb 2017 [monthly]

    Unknown Status PHASE4

    First recorded

Aug 2007

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Provident Clinical Research
  • Reliant Pharmaceuticals
Data source: Provident Clinical Research

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

Study Locations

No location information available.