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NCT01328093 · ClinicalTrials.gov registry record · Phase 3

A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients

A Phase 3 study, sponsored by Denovo Biopharma.

Terminated
Registry status
Phase 3
Development phase
678
Enrollment target

NCT01328093: Clinical Trial Phase 3 study, sponsored by Denovo Biopharma.

NCT01328093 is a Phase 3 study that was terminated before completion, run by Denovo Biopharma. The registered enrollment target is 678 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01328093, a Phase 3 study, was terminated before completion, sponsored by Denovo Biopharma.

TERMINATED
Registry status
Phase 3
Development phase
678 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether weight gain will be significantly less in LY2140023 than aripiprazole in patients with schizophrenia.

Primary Outcome

Mixed model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigator, visit, prior olanzapine use, treatment-by-visit interaction and baseline-by-visit interaction.

Interventions

  • DRUG Aripiprazole
  • DRUG LY2140023

Trial Details

FieldValue
Enrollment Target 678 participants
Start Date 2011-04
Est. Completion 2012-10
Phase Phase 3
Denovo Biopharma

10 total trials

Why NCT01328093 stopped before completion

NCT01328093 is an interventional study that assigns participants to a tested intervention. The registered 678 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower).

The record links to 0 conditions, and to 2 interventions - of which Aripiprazole is the first listed.

NCT01328093 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01328093 about?

NCT01328093 is a clinical study titled "A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients". The purpose of this study is to determine whether weight gain will be significantly less in LY2140023 than aripiprazole in patients with schizophrenia.

What is the current status of trial NCT01328093?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 678 participants. The study started on 2011-04. Estimated completion is 2012-10.

What interventions are being tested in trial NCT01328093?

The interventions under investigation include: Aripiprazole (DRUG), LY2140023 (DRUG).

Who is sponsoring clinical trial NCT01328093?

This trial is sponsored by Denovo Biopharma, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01328093's enrollment target sits among peer trials

678 536th of 2000 higher than 1,464 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01328093, the US trial registry maintained by the National Library of Medicine. NCT01328093 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.