Trial · NCT02604407

Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)

NCT02604407, Phase 3, Completed, Shire; results first posted 2017-06-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD). Trials, record NCT02604407. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02604407

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
NCT number: NCT02604407
Status: Completed
Phases: Phase 3
Enrollment: 275 participants, actual
Lead sponsor: Shire
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Interventions: SHP465 12.5mg capsules (one capsule daily), Placebo, SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)
First posted: 2015-11-13
Last updated: 2021-06-03
Results first posted: 2017-06-14

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)	Baseline, Visit 6 (Week 4)	The ADHD-RS was developed to measure the behaviors of children with Attention deficit hyperactivity disorder (ADHD). The adult ADHD-RS with prompts consists of 18 items designated to reflect current symptomatology of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher score = more severe symptoms.The scale is subdivided into 2 subscales of 9 symptoms each: hyperactivity/impulsivity and inattentiveness. Adult prompts are included with the ADHD-RS to create a semistructured measurement that allows the clinician to probe the extent, frequency, breadth, severity, and consequences of these symptoms to ascertain impairment in an adult population.
Secondary	Clinical Global Impression of Improvement (CGI-I) Score at Visit 6 (Week 4)	Visit 6 (Week 4)	CGI scales permit a global evaluation of the participant's severity and improvement over time. CGI-I was performed to rate the severity of a participant's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)	Baseline, Visit 6 (Week 4)	Full Analysis Set (FAS) consisted of all participants in the safety set who had at least 1 post dose baseline primary efficacy assessment (ADHD-RS with prompt total score) on treatment.	Units on a scale	MEAN
SECONDARY	Clinical Global Impression of Improvement (CGI-I) Score at Visit 6 (Week 4)	Visit 6 (Week 4)	Full-analysis set (FAS) consisted of all participants in the safety set who had at least 1 postdose baseline primary efficacy assessment (ADHD-RS with prompt total score) on treatment with number of participants evaluable for this outcome.	Units on a scale	MEAN

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)	Placebo	Baseline	40.5	Standard Deviation 6.52	Units on a scale
Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)	SHP465 12.5 mg	Baseline	39.8	Standard Deviation 6.38	Units on a scale
Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)	SHP465 37.5 mg	Baseline	39.9	Standard Deviation 7.07	Units on a scale
Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)	Placebo	Change at Visit 6	-11.0	Standard Deviation 11.47	Units on a scale
Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)	SHP465 12.5 mg	Change at Visit 6	-18.1	Standard Deviation 13.42	Units on a scale
Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)	SHP465 37.5 mg	Change at Visit 6	-23.8	Standard Deviation 11.89	Units on a scale
Clinical Global Impression of Improvement (CGI-I) Score at Visit 6 (Week 4)	Placebo		3.1	Standard Deviation 1.05	Units on a scale
Clinical Global Impression of Improvement (CGI-I) Score at Visit 6 (Week 4)	SHP465 12.5 mg		2.4	Standard Deviation 1.16	Units on a scale
Clinical Global Impression of Improvement (CGI-I) Score at Visit 6 (Week 4)	SHP465 37.5 mg		1.9	Standard Deviation 1.10	Units on a scale

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	91
Overall Study	STARTED	SHP465 12.5 mg	92
Overall Study	STARTED	SHP465 37.5 mg	92
Overall Study	TREATED	Placebo	89
Overall Study	TREATED	SHP465 12.5 mg	92
Overall Study	TREATED	SHP465 37.5 mg	90
Overall Study	COMPLETED	Placebo	80
Overall Study	COMPLETED	SHP465 12.5 mg	80
Overall Study	COMPLETED	SHP465 37.5 mg	76
Overall Study	NOT COMPLETED	Placebo	11

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events24

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	Dry mouth	Gastrointestinal disorders	Placebo	3	89	3
other	Dry mouth	Gastrointestinal disorders	SHP465 12.5 mg	13	92	13
other	Dry mouth	Gastrointestinal disorders	SHP465 37.5 mg	20	90	20
other	Decreased appetite	Metabolism and nutrition disorders	Placebo	4	89	4
other	Decreased appetite	Metabolism and nutrition disorders	SHP465 12.5 mg	18	92	18
other	Decreased appetite	Metabolism and nutrition disorders	SHP465 37.5 mg	27	90	27
other	Headache	Nervous system disorders	Placebo	4	89	4
other	Headache	Nervous system disorders	SHP465 12.5 mg	6	92	6
other	Headache	Nervous system disorders	SHP465 37.5 mg	11	90	11
other	Anxiety	Psychiatric disorders	Placebo	1	89	1

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	SHP465 12.5 mg
Total, all-cause mortality	SHP465 37.5 mg
Total, other adverse events	Placebo	12	89
Total, other adverse events	SHP465 12.5 mg	44	92
Total, other adverse events	SHP465 37.5 mg	49	90
Total, serious adverse events	Placebo	0	89
Total, serious adverse events	SHP465 12.5 mg	0	92
Total, serious adverse events	SHP465 37.5 mg	0	90

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28712074	DERIVED

Source PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02604407

GET https://conductscience.org/api/trials/v1/NCT02604407/events?page=2

API reference For AI assistants