Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000679-90 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Experimental | Overencapsulated LDX 30, 50, or 70mg |
|
| Methylphenidate Hydrochloride | Active Comparator | Overencapsulated Concerta 18, 36, or 54mg |
|
| Placebo | Placebo Comparator | Overencapsulated Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Drug | 30, 50 or 70mg capsule once per day (Overencapsulated) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 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. A decrease in score indicates an improvement in ADHD symptomology. | Baseline and up to 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | 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. | Up to 7 weeks |
Not provided
Inclusion Criteria:
Exclusion 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 |
|---|---|---|---|---|---|---|
| ZiekenhuisNetwerk Antwerpen, Commandant Weynsstraat 165, Campus Hoge Beuken | Hoboken | Antwerp | 2660 | Belgium | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23332456 | Result | Coghill D, Banaschewski T, Lecendreux M, Soutullo C, Johnson M, Zuddas A, Anderson C, Civil R, Higgins N, Lyne A, Squires L. European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol. 2013 Oct;23(10):1208-18. doi: 10.1016/j.euroneuro.2012.11.012. Epub 2013 Jan 15. | |
| 23708466 |
| Label | URL |
|---|---|
| FDA recal information | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lisdexamfetamine Dimesylate (LDX) | Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg. |
| FG001 | Methylphenidate Hydrochloride |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Methylphenidate Hydrochloride | Drug | 18, 36, or 54mg tablet one per day (Overencapsulated) |
|
|
| Placebo | Drug | Placebo capsule once per day (Overencapsulated) |
|
| Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks | The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior. | Baseline and up to 7 weeks |
| Health Utilities Index-2 (HUI-2) Scores at up to 7 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. | Baseline and up to 7 weeks |
| Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks | The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health. | Baseline and up to 7 weeks |
| Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 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 7 weeks |
| Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 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 7 weeks |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS is a 19-item semi-structured interview designed to capture suicide-related thoughts and behaviors. | Up to 7 weeks |
| Universitair Ziekenhuis Gent, Kinder-en Jeugdpsychiatrie, De Pintelaan 185 |
| Ghent |
| East Flanders |
| 9000 |
| Belgium |
| Afdeling Psychiatrie, UZ Herestraat 49, Bus 07003 | Leuven | 3000 | Belgium |
| Hospital Archet 2 | Nice | Cedex 03 | 6202 | France |
| Centre Hospitalier Charles Perrens, Bordeaux, Service de Psychiatrie de l'Enfant et de l'Adolescent | Bordeaux Cédex | 33076 | France |
| Hôpital Gui de Chauliac, 80, avenue Augustin Fliche | Montpellier | 34295 | France |
| Hôpital Robert Debré, Service de Psychopathologie de l'Enfant et de l'Adolescent | Paris | Île-de-France Region | 75019 | France |
| Zentralinstitut für Seelische Gesundheit Mannheim, Klinik für Psychiatrie und Psychotherapie des Kindes-und Jug, J4/J5 | Mannheim | Baden Wuttemburg | 68159 | Germany |
| Schwerpunktpraxis für Entwicklung und Lernen, Heinrichsdamm 6 | Bamberg | Bavaria | 96047 | Germany |
| Medizinisches Studienzentrum Würzburg, Augustinerstrasse 10 | Würzburg | Bavaria | 97070 | Germany |
| Universität Würzburg, Klinik und Poliklinik fuer Kinder-und Jugendpsychiatrie und Psychotherapie | Würzburg | Bavaria | 97080 | Germany |
| Universitatsklinikum Gießen und Marburg GmbH, Hans-Sachs-Strasse 4 | Marburg | Hesse | 35039 | Germany |
| Universitat Gottingen | Göttingen | Lower Saxony | 37075 | Germany |
| Klinikum der Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Kinder-und Jugendpsychiatrie und-psychotherapie, | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Universitätsmedizin Berlin | Berlin | 13353 | Germany |
| Albert-Ludwigs-Universitat Freiburg | Freiburg im Breisgau | 79104 | Germany |
| Praxis Dr. Walter Robert Otto | Fulda | 36037 | Germany |
| Praxis Dr. Wolff | Hagen | 58093 | Germany |
| Praxis Dr. med. Friedrich Kaiser und Dr. med. Ingrid Marinesse | Hamburg | 22415 | Germany |
| Praxis für Neuropädiatrie, Schomburgstrasse 120 | Hamburg | 22767 | Germany |
| Vadaskert Kórház és Szakambulancia | Budapest | 1021 | Hungary |
| Pándy Kálmán Kórház | Gyula | 5700 | Hungary |
| Gyermek és Ifjúságpszichiátriai Szakrendelés és Gondozó | Pécs | 7632 | Hungary |
| Szegedi Tudományegyetem | Szeged | 6750 | Hungary |
| Università degli Studi di Cagliari, Dipartimento di Neuroscienze | Cagliari | 9124 | Italy |
| Azienda Ospedaliera Universitaria Policlinico G. Martino | Messina | 98125 | Italy |
| Azienda Ospedaliera della 2 Universita di Napoli | Naples | 80131 | Italy |
| Academisch Ziekenhuis Maastricht | Maastricht | 6229 HX | Netherlands |
| Universitair Medisch Centrum Sint Radboud, Reinier Postlaan 10 | Nijmegen | 6525 GC | Netherlands |
| Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-094 | Poland |
| Wojewodzki Osrodek Lecznictwa Psychiatrycznego | Torun | Kuyavian-Pomeranian Voivodeship | 87-100 | Poland |
| Samodzielny Publiczny Dzieciecy Szpital Kliniczny | Warsaw | Masovian Voivodeship | 00-576 | Poland |
| Gdanski Uniwersytet Medyczna w Gdansku | Gdansk | Pomeranian Voivodeship | 80-282 | Poland |
| Hospital Sant Joan de Dèu | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Hospital Marítimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J), Carretera del Sanatorio s/n | Torremolinos | Malaga | 29630 | Spain |
| Clínica Universitaria de Navarra, Unidad de Psiquiatría Infantil y Adolescente, Dept. de Psiquiatría y Psicología Médica | Pamplona | Navarre | 31080 | Spain |
| Hospital Universitario de Canarias C/Ofra | San Cristóbal de La Laguna | Santa Cruz De Tenerife | 38320 | Spain |
| Complejo Hospitalario Universitario de Badajoz | Badajoz | 6010 | Spain |
| Mutua de Terrassa | Barcelona | 8221 | Spain |
| Hospital Ramón y Cajal, Servicio de psiquiatría | Madrid | 28034 | Spain |
| Utvecklingsneurologiska Enheten (UNE), BUC, Lockerudsv 12 | Mariestad | Vastergotland | 54224 | Sweden |
| Drottning Silvias Barnsjukhus | Gothenburg | 41119 | Sweden |
| Astrid Lindgren Children's Hospital, Karolinska University Hospital | Stockholm | 171 76 | Sweden |
| Barn och Ungdomsmedicin klinik Mölnlycke, Ekdalavägen 2,Box 9 | Stockholm | 435 30 | Sweden |
| Basildon Hospital, Child Developement Centre, Nethermayne | Basildon | Essex | SS16 5NL | United Kingdom |
| Lighthouse Child Development Centre, Snakes Lane | Southend-on-Sea | Essex | SS2 6XT | United Kingdom |
| Victoria Hospital, Paediatric Unit, Hayfield Road | Kirkcaldy | Fife, Scotland | KY2 5AH | United Kingdom |
| Tayside Childrens Hospital, Clinical Research Facility, Level 4 | Dundee | Scotland | DD1 9SY | United Kingdom |
| Ryegate Children's Centre, Tapton Crescent Road | Sheffield | Yorkshire | S10 5DD | United Kingdom |
| Result |
| Coghill DR, Banaschewski T, Lecendreux M, Zuddas A, Dittmann RW, Otero IH, Civil R, Bloomfield R, Squires LA. Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial. Eur Child Adolesc Psychiatry. 2014 Feb;23(2):61-8. doi: 10.1007/s00787-013-0421-y. Epub 2013 May 25. |
| 23893527 | Result | Banaschewski T, Soutullo C, Lecendreux M, Johnson M, Zuddas A, Hodgkins P, Adeyi B, Squires LA, Coghill D. Health-related quality of life and functional outcomes from a randomized, controlled study of lisdexamfetamine dimesylate in children and adolescents with attention deficit hyperactivity disorder. CNS Drugs. 2013 Oct;27(10):829-40. doi: 10.1007/s40263-013-0095-5. |
| 26409610 | Derived | Setyawan J, Yang H, Cheng D, Cai X, Signorovitch J, Xie J, Erder MH. Developing a Risk Score to Guide Individualized Treatment Selection in Attention Deficit/Hyperactivity Disorder. Value Health. 2015 Sep;18(6):824-31. doi: 10.1016/j.jval.2015.06.005. Epub 2015 Aug 20. |
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg. |
| FG002 | Placebo | Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lisdexamfetamine Dimesylate (LDX) | Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg. |
| BG001 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg. |
| BG002 | Placebo | Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks. |
| BG003 | 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 | Safety Population was used for demographics. Safety Population defined as all subjects who took at least 1 dose of investigational product. Four randomized subjects (2 in the LDX group, 1 in the Methylphenidate group, and 1 in the placebo group) did not receive investigational product and were therefore excluded from the Safety Population (n = 332). | Mean | Standard Deviation | years |
| ||||||||||||||
| Age, Customized | Safety Population was used for demographics. Safety Population defined as all subjects who took at least 1 dose of investigational product. Four randomized subjects (2 in the LDX group, 1 in the Methylphenidate group, and 1 in the placebo group) did not receive investigational product and were therefore excluded from the Safety Population (n = 332). | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Safety Population was used for demographics. Safety Population defined as all subjects who took at least 1 dose of investigational product. Four randomized subjects (2 in the LDX group, 1 in the Methylphenidate group, and 1 in the placebo group) did not receive investigational product and were therefore excluded from the Safety Population( n = 332). | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | This includes All Enrolled Subjects. Enrolled Population defined as all subjects who were randomized (n = 336). | 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 Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 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. A decrease in score indicates an improvement in ADHD symptomology. | Full Analysis set (FAS) defined as all subjects who were randomized and who took at least 1 dose of investigational product. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline and up to 7 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | 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. | FAS | Posted | Number | percentage of participants | Up to 7 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks | The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior. | FAS | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline and up to 7 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Health Utilities Index-2 (HUI-2) Scores at up to 7 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. | FAS | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and up to 7 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks | The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health. | FAS | Posted | Least Squares Mean | Standard Error | T-scores | Baseline and up to 7 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 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. | FAS | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline and up to 7 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 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 took at least 1 dose of investigational product. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and up to 7 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS is a 19-item semi-structured interview designed to capture suicide-related thoughts and behaviors. | Safety Population | Posted | Number | participants | Up to 7 weeks |
|
|
Not provided
Safety Population defined as all subjects who took 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 (LDX) | Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg. | 3 | 111 | 80 | 111 | ||
| EG001 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg. | 2 | 111 | 72 | 111 | ||
| EG002 | Placebo | Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks. | 3 | 110 | 63 | 110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders |
| |||
| Gastroesophageal reflux disease | Gastrointestinal disorders |
| |||
| Appendicitis | Infections and infestations |
| |||
| Loss of conciousness | Nervous system disorders |
| |||
| Hematoma | Vascular disorders |
| |||
| Clavicle fracture | Injury, poisoning and procedural complications |
| |||
| Overdose | Injury, poisoning and procedural complications |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders |
| |||
| Abdominal upper pain | Gastrointestinal disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Fatigue | General disorders |
| |||
| Irritability | General disorders |
| |||
| Pyrexia | General disorders |
| |||
| Gastroenteritis | Infections and infestations |
| |||
| Influenza | Infections and infestations |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Upper respiratory tract infection | Infections and infestations |
| |||
| Joint sprain | Injury, poisoning and procedural complications |
| |||
| Wrong drug administered | Injury, poisoning and procedural complications |
| |||
| Electrocardiogram QT prolonged | Investigations |
| |||
| Weight decreased | Investigations |
| |||
| Anorexia | Metabolism and nutrition disorders |
| |||
| Decreased appetite | Metabolism and nutrition disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Migraine | Nervous system disorders |
| |||
| Aggression | Psychiatric disorders |
| |||
| Initial insomnia | Psychiatric disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Sleep disorder | Psychiatric disorders |
| |||
| Tic | Psychiatric disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Erythema | Skin and subcutaneous tissue 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 |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| 13-17 years |
|
| Male |
|
| Hungary |
|
| Spain |
|
| Poland |
|
| Belgium |
|
| Netherlands |
|
| Germany |
|
| United Kingdom |
|
| Italy |
|
| Sweden |
|
| difference in LS means |
| -13.0 |
| 2-Sided |
| 95 |
| -15.9 |
| -10.2 |
| Superiority or Other (legacy) |
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| Participants |
|
|