Trial · NCT01244490
Efficacy and Safety of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT01244490, Phase 3, Completed, Shire; results first posted 2014-07-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD). Trials, record NCT01244490. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01244490
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
- NCT number
- NCT01244490
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 338 participants, actual
- Lead sponsor
- Shire
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Extended-release Guanfacine Hydrochloride, Atomoxetine Hydrochloride, Placebo Comparator
- First posted
- 2010-11-19
- Last updated
- 2021-07-02
- Other registries' IDs
- eudract:2010-018579-12
- Results first posted
- 2014-07-14
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 10/13 - Last Observation Carried Forward (LOCF) | Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | 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. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. |
| Secondary | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. |
| Secondary | Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 10/13 - LOCF | Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | The WFIRS-P Learning in School Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. |
| Secondary | Change From Baseline in the WFIRS-P Family Domain Score at Week 10/13 - LOCF | Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | The WFIRS-P Family Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. |
| Secondary | Clinical Global Impression-Severity of Illness (CGI-S) - LOCF | Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. |
| Secondary | Health Utilities Index-2/3 (HUI 2/3) Scores - LOCF | Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. |
| Secondary | Change From Baseline in the WFIRS-P Global Score at Week 10/13 - LOCF | Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | The WFIRS-P Global Score is the mean of 50 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. |
| Secondary | Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 10/13 - LOCF | Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | The WFIRS-P Academic Performance Domain is the mean of 4 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. |
| Secondary | Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 10/13 - LOCF | Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | The WFIRS-P Behavior in School Domain is the mean of 6 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. |
| Secondary | Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 10/13 - LOCF | Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | The WFIRS-P Life Skills Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
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 Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 10/13 - Last Observation Carried Forward (LOCF) | Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | Full Analysis Set (FAS) defined as all randomized subjects who took at least 1 dose of investigational product. If more than 20% of the items used for summing a score were missing, the score was set to missing. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | Full Analysis Set. Not all subjects in the FAS population had data for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 10/13 - LOCF | Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the WFIRS-P Family Domain Score at Week 10/13 - LOCF | Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression-Severity of Illness (CGI-S) - LOCF | Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | Full Analysis Set. Not all subjects in the FAS population had data for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Health Utilities Index-2/3 (HUI 2/3) Scores - LOCF | Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | Full Analysis Set. Not all subjects in the FAS population had data for this outcome. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the WFIRS-P Global Score at Week 10/13 - LOCF | Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 10/13 - LOCF | Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 10/13 - LOCF | Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 10/13 - LOCF | Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years | Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group114
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 Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 10/13 - Last Observation Carried Forward (LOCF) | Placebo | -15.0 | Standard Error 1.1612 | units on a scale | |
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 10/13 - Last Observation Carried Forward (LOCF) | Guanfacine Hydrochloride | -23.9 | Standard Error 1.1531 | units on a scale | |
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 10/13 - Last Observation Carried Forward (LOCF) | Atomoxetine Hydrochloride | -18.8 | Standard Error 1.1549 | units on a scale | |
| Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | Placebo | 44.1 | percentage of participants | ||
| Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | Guanfacine Hydrochloride | 67.9 | percentage of participants | ||
| Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | Atomoxetine Hydrochloride | 56.3 | percentage of participants | ||
| Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 10/13 - LOCF | Placebo | -0.419 | Standard Error 0.0537 | units on a scale | |
| Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 10/13 - LOCF | Guanfacine Hydrochloride | -0.636 | Standard Error 0.0527 | units on a scale | |
| Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 10/13 - LOCF | Atomoxetine Hydrochloride | -0.581 | Standard Error 0.0534 | units on a scale | |
| Change From Baseline in the WFIRS-P Family Domain Score at Week 10/13 - LOCF | Placebo | -0.409 | Standard Error 0.0568 | units on a scale |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 111 | |
| Overall Study | STARTED | Guanfacine Hydrochloride | 115 | |
| Overall Study | STARTED | Atomoxetine Hydrochloride | 112 | |
| Overall Study | COMPLETED | Placebo | 92 | |
| Overall Study | COMPLETED | Guanfacine Hydrochloride | 91 | |
| Overall Study | COMPLETED | Atomoxetine Hydrochloride | 89 | |
| Overall Study | NOT COMPLETED | Placebo | 19 | |
| Overall Study | NOT COMPLETED | Guanfacine Hydrochloride | 24 | |
| Overall Study | NOT COMPLETED | Atomoxetine Hydrochloride | 23 |
Source ClinicalTrials.gov
Adverse events51
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 | Gastrointestinal disorders | Placebo | 20 | 111 | 32 |
| other | Abdominal pain | Gastrointestinal disorders | Guanfacine Hydrochloride | 19 | 114 | 29 |
| other | Abdominal pain | Gastrointestinal disorders | Atomoxetine Hydrochloride | 19 | 112 | 31 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 6 | 111 | 6 |
| other | Abdominal pain upper | Gastrointestinal disorders | Guanfacine Hydrochloride | 7 | 114 | 7 |
| other | Abdominal pain upper | Gastrointestinal disorders | Atomoxetine Hydrochloride | 2 | 112 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 15 | 111 | 18 |
| other | Diarrhoea | Gastrointestinal disorders | Guanfacine Hydrochloride | 10 | 114 | 16 |
| other | Diarrhoea | Gastrointestinal disorders | Atomoxetine Hydrochloride | 2 | 112 | 3 |
| other | Nausea | Gastrointestinal disorders | Placebo | 11 | 111 | 13 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Guanfacine Hydrochloride | ||
| Total, all-cause mortality | Atomoxetine Hydrochloride | ||
| Total, other adverse events | Placebo | 62 | 111 |
| Total, other adverse events | Guanfacine Hydrochloride | 79 | 114 |
| Total, other adverse events | Atomoxetine Hydrochloride | 67 | 112 |
| Total, serious adverse events | Placebo | 1 | 111 |
| Total, serious adverse events | Guanfacine Hydrochloride | 1 | 114 |
| Total, serious adverse events | Atomoxetine Hydrochloride | 0 | 112 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25453486 | RESULT |
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.
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.
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