deltatrials
Terminated PHASE2 INTERVENTIONAL 2-arm NCT01972178

Efficacy and Safety of PRC-4016 in Subjects With Mixed Dyslipidemia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled 12-Week Phase II Proof of Concept Study to Evaluate the Efficacy and Safety of PRC-4016 600 mg Once Daily Versus Placebo in Statin-Stable Subjects With Mixed Dyslipidemia

Sponsor: Pronova BioPharma

Conditions Dyslipidemia
Updated 7 times since 2017 Last updated: Oct 7, 2015 Started: Nov 30, 2013 Primary completion: Jul 31, 2014 Completion: Aug 31, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

This trial was terminated. No reason was provided.

Listed as NCT01972178, this PHASE2 trial focuses on Dyslipidemia and remains terminated or withdrawn. Sponsored by Pronova BioPharma, it has been updated 7 times since 2013, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification

6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Apr 2022 · 15 months · monthly snapshotTerminated~Apr 2022 – ~Jul 2024 · 27 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  3. Apr 2022 — Jul 2024 [monthly]

    Terminated PHASE2

  4. Jan 2021 — Apr 2022 [monthly]

    Terminated PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE2

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

    Terminated PHASE2

  2. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE2

    First recorded

Nov 2013

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Pronova BioPharma
Data source: Pronova BioPharma

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