Trial · NCT01470469

SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP)

NCT01470469, Phase 2, Completed, Shire; results first posted 2014-05-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP). Trials, record NCT01470469. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01470469

On this page

Trial

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

Title: SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP)
NCT number: NCT01470469
Status: Completed
Phases: Phase 2
Enrollment: 83 participants, actual
Lead sponsor: Shire
Conditions: Generalized Anxiety Disorder (GAD), Anxiety, Separation, Phobia, Social
Interventions: SPD503 (extended-release Guanfacine hydrochloride), Placebo
First posted: 2011-11-11
Last updated: 2021-06-10
Results first posted: 2014-05-23
Limitations and caveats: Efficacy endpoints were exploratory. No statistical testing was performed because the study was not powered.

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks	Baseline and up to 12 weeks
Primary	Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks	Baseline and up to 12 weeks
Primary	Change From Baseline in Pulse Rate at Up to 12 Weeks	Baseline and up to 12 weeks
Primary	Change From Baseline in Height at up to 12 Weeks	Baseline and up to 12 weeks
Primary	Change From Baseline in Weight at up to 12 Weeks	Baseline and up to 12 weeks
Primary	Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks	Baseline and up to 12 weeks	QRS complex is a portion of the ECG tracing that represents depolarization of the ventricular myocardium.
Primary	Change From Baseline in ECG QTcF Interval at up to 12 Weeks	Baseline and up to 12 weeks	The QT interval is the time from the start of the Q wave to the end of the T wave. It is a portion of the ECG tracing that represents the time taken for ventricular depolarisation and repolarisation. The QTcF includes a correction factor to help account for changes in heart rate.

Source ClinicalTrials.gov

Outcomes7

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 Systolic Blood Pressure at Up to 12 Weeks	Baseline and up to 12 weeks	Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.	mmHg	MEAN
PRIMARY	Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks	Baseline and up to 12 weeks	Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.	mmHg	MEAN
PRIMARY	Change From Baseline in Pulse Rate at Up to 12 Weeks	Baseline and up to 12 weeks	Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.	beats/min	MEAN
PRIMARY	Change From Baseline in Height at up to 12 Weeks	Baseline and up to 12 weeks	Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.	cm	MEAN
PRIMARY	Change From Baseline in Weight at up to 12 Weeks	Baseline and up to 12 weeks	Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.	kg	MEAN
PRIMARY	Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks	Baseline and up to 12 weeks	Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.	msec	MEAN
PRIMARY	Change From Baseline in ECG QTcF Interval at up to 12 Weeks	Baseline and up to 12 weeks	Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.	msec	MEAN

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks	PLACEBO	-1.7	Standard Deviation 11.18	mmHg
Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks	SPD503	-2.3	Standard Deviation 11.40	mmHg
Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks	PLACEBO	0.9	Standard Deviation 7.37	mmHg
Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks	SPD503	-1.3	Standard Deviation 9.09	mmHg
Change From Baseline in Pulse Rate at Up to 12 Weeks	PLACEBO	-0.5	Standard Deviation 11.09	beats/min
Change From Baseline in Pulse Rate at Up to 12 Weeks	SPD503	-1.8	Standard Deviation 11.54	beats/min
Change From Baseline in Height at up to 12 Weeks	PLACEBO	0.5	Standard Deviation 0.91	cm
Change From Baseline in Height at up to 12 Weeks	SPD503	1.0	Standard Deviation 1.79	cm
Change From Baseline in Weight at up to 12 Weeks	PLACEBO	0.7	Standard Deviation 1.73	kg
Change From Baseline in Weight at up to 12 Weeks	SPD503	1.3	Standard Deviation 1.57	kg

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	PLACEBO	21
Overall Study	STARTED	SPD503	62
Overall Study	COMPLETED	PLACEBO	11
Overall Study	COMPLETED	SPD503	38
Overall Study	NOT COMPLETED	PLACEBO	10
Overall Study	NOT COMPLETED	SPD503	24

Source ClinicalTrials.gov

Adverse events40

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	Abdominal pain upper	Gastrointestinal disorders	PLACEBO	2	21	2
other	Abdominal pain upper	Gastrointestinal disorders	SPD503	10	62	17
other	Constipation	Gastrointestinal disorders	PLACEBO	0	21	0
other	Constipation	Gastrointestinal disorders	SPD503	6	62	6
other	Diarrhoea	Gastrointestinal disorders	PLACEBO	2	21	2
other	Diarrhoea	Gastrointestinal disorders	SPD503	4	62	6
other	Dry mouth	Gastrointestinal disorders	PLACEBO	0	21	0
other	Dry mouth	Gastrointestinal disorders	SPD503	4	62	4
other	Nausea	Gastrointestinal disorders	PLACEBO	2	21	2
other	Nausea	Gastrointestinal disorders	SPD503	5	62	5

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PLACEBO
Total, all-cause mortality	SPD503
Total, other adverse events	PLACEBO	10	21
Total, other adverse events	SPD503	48	62
Total, serious adverse events	PLACEBO	0	21
Total, serious adverse events	SPD503	0	62

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28165762	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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
SPD503 vs PLACEBO: serious adverse events

Source Trial comparisons

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/NCT01470469

GET https://conductscience.org/api/trials/v1/NCT01470469/events?page=2

API reference For AI assistants