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NCT00730691 · ClinicalTrials.gov registry record · Phase 3

Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

A Phase 3 study, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
781
Enrollment target

NCT00730691: Completed Phase 3 study, sponsored by Takeda.

NCT00730691 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 781 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00730691, a Phase 3 study, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
781 participants
Enrollment target

Study Summary

The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in adults with generalized anxiety disorder.

Primary Outcome

The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe

Interventions

  • DRUG Placebo
  • DRUG Duloxetine
  • DRUG Vortioxetine

Trial Details

FieldValue
Enrollment Target 781 participants
Start Date 2008-06
Est. Completion 2009-02
Phase Phase 3
Takeda

408 total trials

What the finished NCT00730691 record still lists

NCT00730691 is an interventional study that assigns participants to a tested intervention. The registered 781 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

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

NCT00730691 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00730691 about?

NCT00730691 is a clinical study titled "Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder". The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in adults with generalized anxiety disorder.

What is the current status of trial NCT00730691?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 781 participants. The study started on 2008-06. Estimated completion is 2009-02.

What interventions are being tested in trial NCT00730691?

The interventions under investigation include: Placebo (DRUG), Duloxetine (DRUG), Vortioxetine (DRUG).

Who is sponsoring clinical trial NCT00730691?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00730691's enrollment target sits among peer trials

781 434th of 2000 higher than 1,567 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 NCT00730691, the US trial registry maintained by the National Library of Medicine. NCT00730691 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.