Trial · NCT00337285
An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
NCT00337285, Phase 3, Completed, New River Pharmaceuticals; results first posted 2009-07-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD). Trials, record NCT00337285. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00337285
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
- NCT number
- NCT00337285
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 349 participants, actual
- Lead sponsor
- New River Pharmaceuticals
- Conditions
- Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders With Hyperactivity, Attention Deficit Hyperactivity Disorders
- Interventions
- Vyvanse (lisdexamfetamine dimesylate), NRP104
- First posted
- 2006-06-15
- Last updated
- 2012-08-20
- Results first posted
- 2009-07-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in ADHD-RS-IV Total Score From Baseline at Up to One Year | up to one year | Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. |
| Secondary | Number of Participants With Improvement on CGI-I | Up to 1 year | Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes 1 and 2 on the scale. |
| Secondary | Change in PSQI Total Score From Baseline at Up to One Year | up to 1 year | Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire consisting of 18 items which generates seven component scores on a scale from 0 (better sleep) to 3 (worse sleep) resulting in a global score of 0-21, where a higher number reflects worse sleep quality. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in ADHD-RS-IV Total Score From Baseline at Up to One Year | up to one year | Intent-to-treat (ITT). Defined as all subjects who were treated and had both the baseline and at least one post-baseline primary efficacy measurement (i.e., ADHD-RS-IV total score) | Units on a scale | MEAN |
| SECONDARY | Number of Participants With Improvement on CGI-I | Up to 1 year | ITT | Participants | NUMBER |
| SECONDARY | Change in PSQI Total Score From Baseline at Up to One Year | up to 1 year | Safety population (Defined as all subjects who were enrolled and who received at least one dose of the investigational product.) | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in ADHD-RS-IV Total Score From Baseline at Up to One Year | Vyvanse | -24.8 | Standard Deviation 11.7 | Units on a scale | |
| Number of Participants With Improvement on CGI-I | Vyvanse | 290 | Participants | ||
| Change in PSQI Total Score From Baseline at Up to One Year | Vyvanse | -1.3 | Standard Deviation 2.8 | Units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vyvanse | 349 | |
| Overall Study | COMPLETED | Vyvanse | 191 | |
| Overall Study | NOT COMPLETED | Vyvanse | 158 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Vyvanse | 76 | 349 | |
| other | Insomnia | Psychiatric disorders | Vyvanse | 68 | 349 | |
| other | Headache | Nervous system disorders | Vyvanse | 60 | 349 | |
| other | Dry mouth | Gastrointestinal disorders | Vyvanse | 58 | 349 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Vyvanse | 50 | 349 | |
| other | Irritability | General disorders | Vyvanse | 39 | 349 | |
| other | Anxiety | Psychiatric disorders | Vyvanse | 29 | 349 | |
| other | Nasopharyngitis | Infections and infestations | Vyvanse | 26 | 349 | |
| other | Sinusitis | Infections and infestations | Vyvanse | 23 | 349 | |
| other | Weight decreased | Investigations | Vyvanse | 21 | 349 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vyvanse | ||
| Total, other adverse events | Vyvanse | 306 | |
| Total, serious adverse events | Vyvanse | 8 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00337285
GET https://conductscience.org/api/trials/v1/NCT00337285/registered