Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPD503 (Guanfacine hydrochloride) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPD503 (Guanfacine hydrochloride) | Drug | Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks | The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms. | Baseline and up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 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. | Baseline and up to 8 weeks |
| Assessment of Clinical Global Impression-Severity of Illness (CGI-S) |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOPE Research Institute | Phoenix | Arizona | 85050 | United States | ||
| Valley Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20806988 | Result | Connor DF, Findling RL, Kollins SH, Sallee F, Lopez FA, Lyne A, Tremblay G. Effects of guanfacine extended release on oppositional symptoms in children aged 6-12 years with attention-deficit hyperactivity disorder and oppositional symptoms: a randomized, double-blind, placebo-controlled trial. CNS Drugs. 2010 Sep;24(9):755-68. doi: 10.2165/11537790-000000000-00000. |
| Label | URL |
|---|---|
| FDA recall information | View source |
Not provided
217 subjects were randomized (138 to SPD503 and 79 to placebo). However, only 214 subjects received at least one dose of study medication (136 for SPD503 and 78 for placebo). Therefore, 214 subjects constitute the safety population.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SPD503 | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo |
|
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) |
| up to 8 weeks |
| Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) | 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. | up to 8 weeks |
| Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks | Each item on the NYPRS-S is scored from a range of 0 (not at all) to 3 (very much) with total scores ranging from 0 to 120. Higher scores are reflective of increased disease severity. | Baseline and up to 8 weeks |
| Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks | The response to each of the 36 items on the PSI/SF is converted to a five-point scale from 1 (strongly agree) to 5 (strongly disagree) with total scores ranging from 36 to 180. A higher score is reflective of less stress for the parents. | Baseline and up to 8 weeks |
| Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS) | The Medication Satisfaction Survey (MSS) consists of 11 questions each being answered with one of six responses (strongly agree, agree, somewhat agree, somewhat disagree, disagree, strongly disagree). Overall satisfaction with their child taking the study medication, Question #11, with a response of "strongly agree" or "agree". | up to 8 weeks |
| Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks | QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation. | Baseline and up to 8 weeks |
| Change From Baseline in Pulse Rate at Up to 8 Weeks | Baseline and up to 8 weeks |
| Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks | Baseline and up to 8 weeks |
| Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks | Baseline and up to 8 weeks |
| El Centro |
| California |
| 92243 |
| United States |
| Peninsula Research Associates Inc | Rolling Hills Estates | California | 90274 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Amedica Research Institute, Inc | Hialeah | Florida | 33013 | United States |
| CORE Research, Inc | Maitland | Florida | 32751 | United States |
| Miami Research Associates | Miami | Florida | 33143 | United States |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | 32806 | United States |
| Childrens Developmental Center | Winter Park | Florida | 32792 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
| Pedia Research | Owensboro | Kentucky | 42301 | United States |
| Four Rivers Clinical Research | Paducah | Kentucky | 42003 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| CRI Worldwide, LLC | Clementon | New Jersey | 08021 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| University of Rochester, School of Medicine and Dentistry | Rochester | New York | 14618 | United States |
| SUNY Upsate Medical University | Syracuse | New York | 13210 | United States |
| Piedmont Neuropsychiatry | Charlotte | North Carolina | 28226 | United States |
| Duke Child & Family Study Center | Durham | North Carolina | 27705 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Discovery and Wellness Center for Children | Cleveland | Ohio | 44106 | United States |
| BHI Inc | Moore | Oklahoma | 73160 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Oregon Center for Clinical Investigations, Inc | Portland | Oregon | 97210 | United States |
| Oregon Center for Clinical Investigations, Inc | Salem | Oregon | 97301 | United States |
| CRI Worldwide, LLC | Philadelphia | Pennsylvania | 19149 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Claghorn-Lesem Research Clinic Inc | Houston | Texas | 77008 | United States |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | United States |
| NeuroScience, Inc | Herndon | Virginia | 20170 | United States |
| Dominion Clinical Research | Midlothian | Virginia | 23112 | United States |
| Eastside Therapeutic Resource | Kirkland | Washington | 98033 | United States |
| FDA-approved label | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SPD503 | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) |
| BG001 | Placebo | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks | The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms. | Full Analysis Set (FAS) defined as all randomized subjects who received at least one dose of any investigational product during this study and with a baseline and at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and up to 8 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 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. | FAS | Posted | Mean | Standard Deviation | Units on a scale | Baseline and up to 8 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) | 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) | FAS | Posted | Number | Participants | up to 8 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) | 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. | FAS | Posted | Number | Participants | up to 8 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks | Each item on the NYPRS-S is scored from a range of 0 (not at all) to 3 (very much) with total scores ranging from 0 to 120. Higher scores are reflective of increased disease severity. | FAS | Posted | Mean | Standard Deviation | units on a scale | Baseline and up to 8 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks | The response to each of the 36 items on the PSI/SF is converted to a five-point scale from 1 (strongly agree) to 5 (strongly disagree) with total scores ranging from 36 to 180. A higher score is reflective of less stress for the parents. | FAS | Posted | Mean | Standard Deviation | Units on a scale | Baseline and up to 8 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS) | The Medication Satisfaction Survey (MSS) consists of 11 questions each being answered with one of six responses (strongly agree, agree, somewhat agree, somewhat disagree, disagree, strongly disagree). Overall satisfaction with their child taking the study medication, Question #11, with a response of "strongly agree" or "agree". | FAS | Posted | Number | Participants | up to 8 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks | QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation. | Safety population defined as all randomized subjects who received at least one dose of any investigational product during this study. | Posted | Mean | Standard Deviation | msec | Baseline and up to 8 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pulse Rate at Up to 8 Weeks | Safety population | Posted | Mean | Standard Deviation | beats/min | Baseline and up to 8 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks | Safety population | Posted | Mean | Standard Deviation | mmHg | Baseline and up to 8 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks | Safety population | Posted | Mean | Standard Deviation | mmHg | Baseline and up to 8 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SPD503 | Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride) | 0 | 136 | 115 | 136 | ||
| EG001 | Placebo | 0 | 78 | 47 | 78 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Sedation | Nervous system disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Abdominal pain upper | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Fatigue | General disorders |
| |||
| Irritability | Psychiatric disorders |
| |||
| Affect lability | Psychiatric disorders |
| |||
| Blood pressure diastolic decreased | Investigations |
| |||
| Upper respiratory tract infection | Infections and infestations |
| |||
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D016316 | Guanfacine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
| >=65 years |
|
| Male |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|