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NCT00190684 · ClinicalTrials.gov registry record · Phase 3

Long-Term, Open Label Atomoxetine Study

A Phase 3 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 3
Development phase
1,553
Enrollment target

NCT00190684: Completed Phase 3 study, sponsored by Eli Lilly and Company.

NCT00190684 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,553 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (101% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00190684, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 3
Development phase
1,553 participants
Enrollment target

Study Summary

To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for about 5 years (long-term). Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been interrupted or, atomoxetine experienced on a known stable dose.

Primary Outcome

Vital signs were assesed categorically using the term high for BP, high and low for pulse and temperature, or decreased for weight. For BP, high was an increase to a value above the 95th percentile of the National Institute of Health (NIH) values. For pulse, high was an increase of at least 25 beats per minute to at least 110, and low was a decrease of at least 20 beats per minute to at most 65 beats per minute. For temperature, high was an increase of at least 1 to 37.7 and low was a decrease o

Interventions

  • DRUG atomoxetine

Trial Details

FieldValue
Enrollment Target 1,553 participants
Start Date 2000-08
Est. Completion 2009-10
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the finished NCT00190684 record still lists

NCT00190684 is an interventional study that assigns participants to a tested intervention. Its 1,553 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (101% higher).

The record links to 0 conditions, and to 1 intervention - of which atomoxetine is the first listed.

NCT00190684 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00190684 about?

NCT00190684 is a clinical study titled "Long-Term, Open Label Atomoxetine Study". To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for about 5 years (long-term). ...

What is the current status of trial NCT00190684?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,553 participants. The study started on 2000-08. Estimated completion is 2009-10.

What interventions are being tested in trial NCT00190684?

The interventions under investigation include: atomoxetine (DRUG).

Who is sponsoring clinical trial NCT00190684?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00190684's enrollment target sits among peer trials

1,553 150th of 2000 higher than 1,851 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 NCT00190684, the US trial registry maintained by the National Library of Medicine. NCT00190684 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.