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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011745-94 | EudraCT Number |
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This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Experimental |
| |
| Atomoxetine Hydrochloride | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine Dimesylate | Drug | Oral 30, 50, or 70mg once-daily for 9 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Response | Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF) | 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. | 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harmonex Neuroscience Research, Inc | Dothan | Alabama | 36303 | United States | ||
| Clinical Study Centers, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23959815 | Result | Dittmann RW, Cardo E, Nagy P, Anderson CS, Bloomfield R, Caballero B, Higgins N, Hodgkins P, Lyne A, Civil R, Coghill D. Efficacy and safety of lisdexamfetamine dimesylate and atomoxetine in the treatment of attention-deficit/hyperactivity disorder: a head-to-head, randomized, double-blind, phase IIIb study. CNS Drugs. 2013 Dec;27(12):1081-92. doi: 10.1007/s40263-013-0104-8. | |
| 25999292 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg. |
| FG001 | Atomoxetine Hydrochloride |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Atomoxetine Hydrochloride | Drug | Oral 10mg to 100mg once-daily for 9 weeks |
|
|
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF | ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology. | Baseline and 9 weeks |
| Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks | 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. | Baseline and up to 9 weeks |
| Health Utilities Index-2 (HUI-2) Scores at Up to 9 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. | up to 9 weeks |
| Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks | The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology. | Baseline and up to 9 weeks |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. | 9 weeks |
| Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | UKU-SERS-Clin is composed of 48 items each of which asks about a single side effect. Each side effect is rated based on a 4-point scale ranging from 0 (no or doubtful presence) to 3 (the least favorable rating). The rating is independent of whether the symptom is regarded as related to the investigational product. | 9 weeks |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Shanti Clinical Trials | Colton | California | 92324 | United States |
| Psychiatric Centers at San Diego Feighner Research | San Diego | California | 92108 | United States |
| Elite Clinical Trials, Inc. | Wildomar | California | 92595 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Amedica Research Institute, Inc. | Hialeah | Florida | 33013 | United States |
| Fidelity Clinical Research, Inc. | Lauderhill | Florida | 33319 | United States |
| Clinical Neuroscience Solutions, INC | Orlando | Florida | 32806 | United States |
| Northwest Behavioral Research Center | Roswell | Georgia | 30076 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| Baber Psychiatric Associates | Naperville | Illinois | 60563 | United States |
| Clinco | Terre Haute | Indiana | 47802 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | United States |
| Four Rivers Clinical Research, Inc | Paducah | Kentucky | 42003 | United States |
| Louisianna Research Associates | New Orleans | Louisiana | 70114 | United States |
| Office of Marc Hertzman, MD, PC | Rockville | Maryland | 20852 | United States |
| Rochester Center for Behavioral Medicine | Rochester Hills | Michigan | 48307 | United States |
| Midwest Research Group/Saint Charles Psychiatric Associates | Saint Charles | Missouri | 63301 | United States |
| Premier Psychiatric Research Institute, LLC | Lincoln | Nebraska | 68526 | United States |
| Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada | 89128 | United States |
| Children's Specialized Hospital | Toms River | New Jersey | 08755 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Triangle Neuropsychiatry, PLLC | Durham | North Carolina | 27707 | United States |
| Innovis Health | Fargo | North Dakota | 58103 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Cyn3rgy Research | Gresham | Oregon | 97030 | United States |
| CRI Worldwide, LLC Kirkbride Division | Philadelphia | Pennsylvania | 19139 | United States |
| Future Search Clinical Trials | Austin | Texas | 78731 | United States |
| Red Oak Psychiatry Association, PA | Houston | Texas | 77090 | United States |
| Western Clinical Investigations | Lubbock | Texas | 79423 | United States |
| Cerebral Research, LLC | San Antonio | Texas | 78247 | United States |
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | United States |
| Eastside Therapeutic Resource | Kirkland | Washington | 98033 | United States |
| ZiekenhuisNetwerk Antwerpen | Hoboken | Antwerpen | 2660 | Belgium |
| Universitair Ziekenhuis Gasthuisberg | Leuven | Flemish Brabant | 3000 | Belgium |
| Child and Adolescent Centre | Edmonton | Alberta | T6H 1P7 | Canada |
| Centre for Anxiety Attention Deficit and Trauma | Hamilton | Ontario | L8S 1B7 | Canada |
| AK Karan Holdings, Ltd. | Oakville | Ontario | L6J 0B2 | Canada |
| The Kids Clinic | Whitby | Ontario | L1N 8M7 | Canada |
| University of Saskatchewan | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Albert-Ludwigs-Universitat Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79104 | Germany |
| Zentralinstitut für Seelische Gesundheit Mannheim | Mannheim | Baden-Wurttemberg | 68159 | Germany |
| Schwerpunktpraxis für Entwicklung und Lernen | Bamberg | Bavaria | 96047 | Germany |
| Medizinisches Studienzentrum Würzburg | Würzburg | Bavaria | 97070 | Germany |
| Klinikum Frankfurt/Oder | Frankfurt (Oder) | Brandenburg | 15236 | Germany |
| Praxis Dr. Wolff | Hagen | North Rhine-Westphalia | 58093 | Germany |
| Szegedi Tudományegyetem Gyermek es lfjusagpszichlatrlai Osztaly | Szeged | Csongrád megye | 6720 | Hungary |
| Vadaskert Korhaz es Szakambulancia Gyermek es lfjusagpszichiatria | Budapest | Hungary |
| Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza | Gyula | 5700 | Hungary |
| Gyermek- es lfjusagpszichiatriai Szakrendeles es Gondozo | Pécs | Hungary |
| Azienda Ospedaliero-Universitaria di Cagliari | Cagliari | 9124 | Italy |
| Katedra i Klinika Psychiatarii | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-096 | Poland |
| Samodzielny Publiczny Dzieciecy Szpital Kliniczny | Warsaw | Masovian Voivodeship | 00-576 | Poland |
| Hospital Son Llà tzer | Palma de Mallorca | Balearic Islands | 7198 | Spain |
| Hospital Sant Joan de Deu | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Hospital MarÃtimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J | Torremolinos | Malaga | 29620 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Santa Cruz De Tenerife | 38320 | Spain |
| Complejo Hospitalario Universitario de Badajoz | Badajoz | 6010 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | 8036 | Spain |
| Drottning Silvias Barnsjukhus | Gothenburg | 411 18 | Sweden |
| Astrid Lindgren Children's Hospital/Karolinska University Hospital | Stockholm | 141 86 | Sweden |
| Basildon Hospital | Basildon | Essex | SS16 5NL | United Kingdom |
| Tayside Children's Hospital | Dundee | Scotland | DD1 9SY | United Kingdom |
| Derived |
| Nagy P, Hage A, Coghill DR, Caballero B, Adeyi B, Anderson CS, Sikirica V, Cardo E. Functional outcomes from a head-to-head, randomized, double-blind trial of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder and an inadequate response to methylphenidate. Eur Child Adolesc Psychiatry. 2016 Feb;25(2):141-9. doi: 10.1007/s00787-015-0718-0. Epub 2015 May 22. |
| 25038977 | Derived | Dittmann RW, Cardo E, Nagy P, Anderson CS, Adeyi B, Caballero B, Hodgkins P, Civil R, Coghill DR. Treatment response and remission in a double-blind, randomized, head-to-head study of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit hyperactivity disorder. CNS Drugs. 2014 Nov;28(11):1059-69. doi: 10.1007/s40263-014-0188-9. |
Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population was used for baseline characteristics (n = 262). Defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. Five randomized subjects did not take any investigational product.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg. |
| BG001 | Atomoxetine Hydrochloride | Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg. |
| 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, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | All enrolled subjects defined as all randomized subjects (n = 267). | 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 | Time to First Response | Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. One subject was randomized to receive Strattera, but actually received Lisdexamfetamine Dimesylate. For all efficacy analyses this subject is included in the Strattera arm per the intention to treat principle. | Posted | Median | 95% Confidence Interval | Days | 9 weeks |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF) | 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. | Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. | Posted | Number | percentage of participants | 9 weeks |
|
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| Secondary | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF | ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology. | Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 9 weeks |
|
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| Secondary | Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks | 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. | Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and up to 9 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Health Utilities Index-2 (HUI-2) Scores at Up to 9 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. | Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. | Posted | Mean | Standard Deviation | units on a scale | up to 9 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks | The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology. | Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. | Posted | Mean | Standard Deviation | units on a scale | Baseline and up to 9 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. | Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. | Posted | Number | participants | 9 weeks |
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| Secondary | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | UKU-SERS-Clin is composed of 48 items each of which asks about a single side effect. Each side effect is rated based on a 4-point scale ranging from 0 (no or doubtful presence) to 3 (the least favorable rating). The rating is independent of whether the symptom is regarded as related to the investigational product. | Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. | Posted | Number | participants | 9 weeks |
|
|
Not provided
Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.
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 | Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg. | 0 | 128 | 92 | 128 | ||
| EG001 | Atomoxetine Hydrochloride | Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg. | 0 | 134 | 95 | 134 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders |
| |||
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders |
| |||
| CONSTIPATION | Gastrointestinal disorders |
| |||
| DIARRHOEA | Gastrointestinal disorders |
| |||
| DRY MOUTH | Gastrointestinal disorders |
| |||
| NAUSEA | Gastrointestinal disorders |
| |||
| VOMITING | Gastrointestinal disorders |
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| FATIGUE | General disorders |
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| IRRITABILITY | General disorders |
| |||
| NASOPHARYNGITIS | Infections and infestations |
| |||
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations |
| |||
| WEIGHT DECREASED | Investigations |
| |||
| DECREASED APPETITE | Metabolism and nutrition disorders |
| |||
| HEADACHE | Nervous system disorders |
| |||
| SEDATION | Nervous system disorders |
| |||
| SOMNOLENCE | Nervous system disorders |
| |||
| INSOMNIA | Psychiatric 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
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011437 | Propylamines |
Not provided
Not provided
| 6 - 12 years |
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| Male |
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