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NCT00044005 · ClinicalTrials.gov registry record · Phase 2

Safety and Tolerability Study of Drug to Treat Schizophrenia

A Phase 2 study, sponsored by Sumitomo Pharma America.

Completed
Registry status
Phase 2
Development phase
98
Enrollment target

NCT00044005: Completed Phase 2 study, sponsored by Sumitomo Pharma America.

NCT00044005 is a Phase 2 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 98 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00044005, a Phase 2 study, has completed, sponsored by Sumitomo Pharma America.

COMPLETED
Registry status
Phase 2
Development phase
98 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.

Primary Outcome

The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.

Interventions

  • DRUG Lurasidone 40 mg
  • DRUG Lurasidone 20 mg
  • DRUG Lurasidone 80mg

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2002-09
Est. Completion 2003-11
Phase Phase 2
Sumitomo Pharma America

168 total trials

What the finished NCT00044005 record still lists

NCT00044005 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).

The record links to 0 conditions, and to 3 interventions - of which Lurasidone 40 mg is the first listed.

NCT00044005 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00044005 about?

NCT00044005 is a clinical study titled "Safety and Tolerability Study of Drug to Treat Schizophrenia". The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.

What is the current status of trial NCT00044005?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2002-09. Estimated completion is 2003-11.

What interventions are being tested in trial NCT00044005?

The interventions under investigation include: Lurasidone 40 mg (DRUG), Lurasidone 20 mg (DRUG), Lurasidone 80mg (DRUG).

Who is sponsoring clinical trial NCT00044005?

This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00044005's enrollment target sits among peer trials

98 743rd of 2000 higher than 1,255 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00044005, the US trial registry maintained by the National Library of Medicine. NCT00044005 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.