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NCT01096680 · ClinicalTrials.gov registry record · Phase 2
Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 135
- Enrollment target
NCT01096680 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 135 participants.
The verdict
NCT01096680, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 135 participants
- Enrollment target
Study Summary
This is a double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation.
Interventions
- DRUG Placebo
- DRUG Armodafinil
- DRUG SPD489 20 mg
- DRUG SPD489 50 mg
- DRUG SPD489 70 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2010-04-05 |
| Est. Completion | 2010-07-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01096680
The ClinicalTrials.gov registry entry for NCT01096680 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 135 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 5 interventions - of which Placebo is the first listed.
NCT01096680 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01096680 about?
NCT01096680 is a clinical study titled "Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss". This is a double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation.
What is the current status of trial NCT01096680?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2010-04-05. Estimated completion is 2010-07-18.
What interventions are being tested in trial NCT01096680?
The interventions under investigation include: Placebo (DRUG), Armodafinil (DRUG), SPD489 20 mg (DRUG), SPD489 50 mg (DRUG), SPD489 70 mg (DRUG).
Who is sponsoring clinical trial NCT01096680?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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