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NCT00764868 · ClinicalTrials.gov registry record · Phase 3
Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 269
- Enrollment target
NCT00764868 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 269 participants.
The verdict
NCT00764868, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 269 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the long-term safety of LDX administered as a daily morning dose (30, 50, and 70 mg/day) in the treatment of adolescents (13-17 years of age inclusive at the time of consent).
Interventions
- DRUG Lisdexamfetamine Dimesylate (LDX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 269 participants |
| Start Date | 2008-11-13 |
| Est. Completion | 2010-04-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00764868
The ClinicalTrials.gov registry entry for NCT00764868 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 269 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lisdexamfetamine Dimesylate (LDX) is the first listed.
NCT00764868 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00764868 about?
NCT00764868 is a clinical study titled "Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study". The primary objective of this study is to evaluate the long-term safety of LDX administered as a daily morning dose (30, 50, and 70 mg/day) in the treatment of adolescents (13-17 years of age inclusive at the time of consent).
What is the current status of trial NCT00764868?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 269 participants. The study started on 2008-11-13. Estimated completion is 2010-04-22.
What interventions are being tested in trial NCT00764868?
The interventions under investigation include: Lisdexamfetamine Dimesylate (LDX) (DRUG).
Who is sponsoring clinical trial NCT00764868?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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