Trial · NCT01081145
Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
NCT01081145, Phase 3, Completed, Shire; results first posted 2014-06-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD). Trials, record NCT01081145. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01081145
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
- NCT number
- NCT01081145
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 528 participants, actual
- Lead sponsor
- Shire
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Interventions
- Extended-release Guanfacine Hydrochloride, Placebo
- First posted
- 2010-03-05
- Last updated
- 2021-06-14
- Other registries' IDs
- eudract:2009-018161-12
- Results first posted
- 2014-06-09
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment Failures During the Double-Blind Randomized-Withdrawal Phase | 26 weeks | Treatment failure was defined as \>= 50% increase (worsening) in ADHD-RS-IV total score and a \>= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment failures for the primary analysis. |
| Secondary | Time to Treatment Failure During the Double-Blind Randomized-Withdrawal Phase | 26 weeks | Treatment failure was defined as \>= 50% increase (worsening) in ADHD-RS-IV total score and a \>= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment failures for the primary analysis. |
| Secondary | Change From Double-Blind Randomized-Withdrawal Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - Last Observation Carried Forward (LOCF) | Baseline and week 26 | 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 | Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale During the Double-Blind Randomized-Withdrawal Phase - LOCF | 26 weeks | CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill) |
| Secondary | Change From Double-Blind Randomized-Withdrawal Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - LOCF | Baseline and week 26 | The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment. |
| Secondary | Health Utilities Index-2/3 (HUI 2/3) Scores During the Double-Blind Randomized-Withdrawal Phase - LOCF | 26 weeks | 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. |
| Secondary | Columbia-Suicide Severity Rating Scale During Double-Blind Randomized-Withdrawal Phase | 26 weeks | C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. |
| Secondary | Change From Open-Label Baseline in ADHD-RS-IV Total Score at Week 13 of the Open-Label Phase - LOCF | Baseline and 13 weeks | 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 | Percentage of Responders in the Open-Label Phase - LOCF | 13 weeks | Response is defined as a percentage decrease (improvement) from Baseline in the ADHD-RS-IV total score of \>=30% and a CGI-S score of 1 or 2. |
| Secondary | Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores During Open-Label Phase - LOCF | 13 weeks | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment Failures During the Double-Blind Randomized-Withdrawal Phase | 26 weeks | Randomized Full Analysis Set (FAS) defined as all subjects who were randomized and took at least 1 dose of investigational product during the Double-blind Randomized-withdrawal Phase. Subjects from Site 801 were excluded from the Randomized FAS. | percentage of treatment failures | NUMBER |
| SECONDARY | Time to Treatment Failure During the Double-Blind Randomized-Withdrawal Phase | 26 weeks | Randomized FAS | Days | MEDIAN |
| SECONDARY | Change From Double-Blind Randomized-Withdrawal Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - Last Observation Carried Forward (LOCF) | Baseline and week 26 | Randomized FAS | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale During the Double-Blind Randomized-Withdrawal Phase - LOCF | 26 weeks | Randomized FAS | percentage of subjects | NUMBER |
| SECONDARY | Change From Double-Blind Randomized-Withdrawal Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - LOCF | Baseline and week 26 | Randomized FAS | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Health Utilities Index-2/3 (HUI 2/3) Scores During the Double-Blind Randomized-Withdrawal Phase - LOCF | 26 weeks | Randomized FAS | units on a scale | MEAN |
| SECONDARY | Columbia-Suicide Severity Rating Scale During Double-Blind Randomized-Withdrawal Phase | 26 weeks | Randomized Safety Population defined as all subjects who were randomized and who took at least 1 dose of investigational product during the Double-blind Randomized-withdrawal Phase. | participants | NUMBER |
| SECONDARY | Change From Open-Label Baseline in ADHD-RS-IV Total Score at Week 13 of the Open-Label Phase - LOCF | Baseline and 13 weeks | Open-label Full Analysis Set (FAS) defined as all subjects who took at least 1 dose of any investigational product during the study. The Subjects from Site 801 were excluded from the Open-label FAS. | units on a scale | MEAN |
| SECONDARY | Percentage of Responders in the Open-Label Phase - LOCF | 13 weeks | Open-label FAS | percentage of participants | NUMBER |
| SECONDARY | Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores During Open-Label Phase - LOCF | 13 weeks | Open-label FAS | percentage of participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment Failures During the Double-Blind Randomized-Withdrawal Phase | Placebo | 64.9 | 95% Confidence Interval 57.3 to 72.5 | percentage of treatment failures | |
| Percentage of Participants With Treatment Failures During the Double-Blind Randomized-Withdrawal Phase | Guanfacine Hydrochloride | 49.3 | 95% Confidence Interval 41.3 to 57.3 | percentage of treatment failures | |
| Time to Treatment Failure During the Double-Blind Randomized-Withdrawal Phase | Placebo | 56.0 | 95% Confidence Interval 44.0 to 97.0 | Days | |
| Time to Treatment Failure During the Double-Blind Randomized-Withdrawal Phase | Guanfacine Hydrochloride | 218.0 | 95% Confidence Interval 118.0 to NA | Days | |
Change From Double-Blind Randomized-Withdrawal Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - Last Observation Carried Forward (LOCF) | Placebo | 15.89 | Standard Error 1.225 | units on a scale | |
Change From Double-Blind Randomized-Withdrawal Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - Last Observation Carried Forward (LOCF) | Guanfacine Hydrochloride | 9.64 | Standard Error 1.21 | units on a scale | |
| Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale During the Double-Blind Randomized-Withdrawal Phase - LOCF | Placebo | 32.5 | percentage of subjects | ||
| Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale During the Double-Blind Randomized-Withdrawal Phase - LOCF | Guanfacine Hydrochloride | 50.0 | percentage of subjects | ||
Change From Double-Blind Randomized-Withdrawal Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - LOCF | Placebo | 0.23 | Standard Error 0.036 | units on a scale | |
Change From Double-Blind Randomized-Withdrawal Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - LOCF | Guanfacine Hydrochloride | 0.16 | Standard Error 0.035 | units on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-Label Phase | STARTED | Guanfacine Hydrochloride | 528 | |
| Open-Label Phase | STARTED | Placebo | 0 | |
| Open-Label Phase | COMPLETED | Guanfacine Hydrochloride | 316 | |
| Open-Label Phase | COMPLETED | Placebo | 0 | |
| Open-Label Phase | NOT COMPLETED | Guanfacine Hydrochloride | 212 | |
| Open-Label Phase | NOT COMPLETED | Placebo | 0 | |
| Double-Blind Randomized-Withdrawal Phase | STARTED | Guanfacine Hydrochloride | 157 | |
| Double-Blind Randomized-Withdrawal Phase | STARTED | Placebo | 159 | |
| Double-Blind Randomized-Withdrawal Phase | COMPLETED | Guanfacine Hydrochloride | 76 | |
| Double-Blind Randomized-Withdrawal Phase | COMPLETED | Placebo | 53 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events75
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 | Guanfacine Hydrochloride (Open-Label Phase) | 60 | 526 | 70 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo (Randomized-Withdrawal Phase) | 8 | 158 | 10 |
| other | Abdominal pain upper | Gastrointestinal disorders | Guanfacine Hydrochloride (Randomized-Withdrawal Phase) | 3 | 157 | 4 |
| other | Constipation | Gastrointestinal disorders | Guanfacine Hydrochloride (Open-Label Phase) | 31 | 526 | 38 |
| other | Constipation | Gastrointestinal disorders | Placebo (Randomized-Withdrawal Phase) | 3 | 158 | 3 |
| other | Constipation | Gastrointestinal disorders | Guanfacine Hydrochloride (Randomized-Withdrawal Phase) | 5 | 157 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Guanfacine Hydrochloride (Open-Label Phase) | 37 | 526 | 46 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (Randomized-Withdrawal Phase) | 3 | 158 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Guanfacine Hydrochloride (Randomized-Withdrawal Phase) | 4 | 157 | 5 |
| other | Nausea | Gastrointestinal disorders | Guanfacine Hydrochloride (Open-Label Phase) | 33 | 526 | 42 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Guanfacine Hydrochloride (Open-Label Phase) | ||
| Total, all-cause mortality | Placebo (Randomized-Withdrawal Phase) | ||
| Total, all-cause mortality | Guanfacine Hydrochloride (Randomized-Withdrawal Phase) | ||
| Total, other adverse events | Guanfacine Hydrochloride (Open-Label Phase) | 423 | 526 |
| Total, other adverse events | Placebo (Randomized-Withdrawal Phase) | 51 | 158 |
| Total, other adverse events | Guanfacine Hydrochloride (Randomized-Withdrawal Phase) | 65 | 157 |
| Total, serious adverse events | Guanfacine Hydrochloride (Open-Label Phase) | 5 | 526 |
| Total, serious adverse events | Placebo (Randomized-Withdrawal Phase) | 4 | 158 |
| Total, serious adverse events | Guanfacine Hydrochloride (Randomized-Withdrawal Phase) | 2 | 157 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26871297 | 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.
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.
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GET https://conductscience.org/api/trials/v1/NCT01081145/results?page=2