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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005452-34 | EudraCT Number |
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The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lisdexamfetamine dimesylate | Experimental |
| |
| Methylphenidate Hydrochloride | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine dimesylate | Drug | Daily oral dosing in the AM ranging from 30- 70 mg. 4 week forced dose titration, 2 week dose maintenance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6 | The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms. | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6 | The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale included a severity of illness item and a global improvement item. The investigator performed the CGI-I to rate the improvement of a participant's ADHD symptoms based on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse.). Percentage of participants with an improved measurement (response of very much improved and much improved) is reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of double-blind investigational product and up to 3 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
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 | ||
| Center for Advanced Improvement |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28980198 | Derived | Newcorn JH, Nagy P, Childress AC, Frick G, Yan B, Pliszka S. Randomized, Double-Blind, Placebo-Controlled Acute Comparator Trials of Lisdexamfetamine and Extended-Release Methylphenidate in Adolescents With Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2017 Nov;31(11):999-1014. doi: 10.1007/s40263-017-0468-2. |
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Of the 778 screened participants, 229 were screen failures and 549 were randomized to treatment. A total of 547 participants were treated and the reasons for 2 'randomized but not treated' participants included withdrawal by 1 participant in the Methylphenidate group and 1 participant with a protocol violation in the Lisdexamfetamine group.
The study was conducted at 77 sites in the United States, Canada, and Europe.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 2 placebo over encapsulated capsules once daily orally for 6 weeks. |
| FG001 | Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 milligram (mg) over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Methylphenidate Hydrochloride | Drug | Daily oral dosing in the AM ranging from 18-72 mg. 4 week force dose titration, 2 week dose maintenance |
|
|
| Placebo | Drug | Daily oral dosing in the AM for 6 weeks |
|
| Week 6 |
| Baseline up to 3 days after last dose (last dose at Week 6) |
| Change From Baseline in Blood Pressure at Week 6 | Baseline, Week 6 |
| Change From Baseline in Pulse Rate at Week 6 | Baseline, Week 6 |
| Tucson |
| Arizona |
| 85719 |
| United States |
| Clinical Study Centers, LLC | Little Rock | Arkansas | 72211 | United States |
| Shanti Clinical Trials | Colton | California | 92324 | United States |
| Sun Valley Research Center | Imperial | California | 92251 | United States |
| Synergy Clinical Research Center | National City | California | 91950 | United States |
| Pacific Sleep Medicine, A Medical Corporation | Oceanside | California | 92054 | United States |
| Neuropsychiatric Research Center for Orange County | Orange | California | 92868 | United States |
| Peninsula Research Associates | Rolling Hills Estates | California | 90274 | United States |
| PCSD - Feighner Research | San Diego | California | 92108 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Elite Clinical Trials | Wildomar | California | 92595 | United States |
| IMMUNOe International Research Center | Centennial | Colorado | 80112 | United States |
| MCB Clinical Research Centers, LLC | Colorado Springs | Colorado | 80910 | United States |
| Coastal Connecticut Research, LLC | New London | Connecticut | 06320 | United States |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34201 | United States |
| Amedica Research Institute, Inc | Hialeah | Florida | 33013 | United States |
| Clinical Neuroscience Solutions, Inc | Jacksonville | Florida | 32256 | United States |
| Sarkis Clinical Trials | Lake City | Florida | 32055 | United States |
| Florida Clinical Research Center, LLC | Maitland | Florida | 32751 | United States |
| Prevention & Strengthening Solutions, Inc. | Miami | Florida | 33169 | United States |
| Scientific Clinical Research, Inc. | North Miami | Florida | 33161 | United States |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32806 | United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Stedman Clinical Trials | Tampa | Florida | 33613 | United States |
| Atlanta Institute of Medicine & Research, Inc | Atlanta | Georgia | 30328 | United States |
| Clinical Research Center, University of Illinois at Chicago | Chicago | Illinois | 60608 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| Baber Research Group | Naperville | Illinois | 60563 | United States |
| Pedia Research, LLC | Newburgh | Indiana | 47630 | United States |
| Psychiatric Associates | Overland Park | Kansas | 66211 | United States |
| Pedia Research, LLC | Owensboro | Kentucky | 42301 | United States |
| Louisiana Resarch Associates, Inc. | New Orleans | Louisiana | 70114 | United States |
| Marc Hertzman, MD, PC | Rockville | Maryland | 20852 | United States |
| Rochester Center for Behavioral Medicine | Rochester Hills | Michigan | 48307 | United States |
| Clinical Neurophysiology Services, PC | Sterling Heights | Michigan | 48314 | United States |
| Behavioral Medical Center - Troy | Troy | Michigan | 48083 | United States |
| Comprehensive Psychiatric Associates | Gladstone | Missouri | 64118 | United States |
| Psychiatric Care & Research Center | O'Fallon | Missouri | 63368 | United States |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63301 | United States |
| Premier Psychiatric Research Institute, LLC | Lincoln | Nebraska | 68526 | United States |
| University of Nebraska Medical Center Dept Of Psychiatry | Omaha | Nebraska | 68198 | United States |
| Center for Psychiatry & Behavioral Medicine, Inc. | Las Vegas | Nevada | 89128 | United States |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| The NeuroCognitive Institute | Mount Arlington | New Jersey | 07856 | United States |
| Albuquerque Neuroscience, Inc. | Albuquerque | New Mexico | 87109 | United States |
| Brain Resource Center | New York | New York | 10023 | United States |
| Mount Sinai School of Medicine/Dept of Psychiaatry | New York | New York | 10029 | United States |
| Duke University medical Center/ Duke ADHD Program | Durham | North Carolina | 27705 | United States |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | United States |
| University of Cincinnati College of Medicine/UCPC | Cincinnati | Ohio | 45219 | United States |
| The Ohio State University Nisonger Center | Columbus | Ohio | 43210 | United States |
| Tulsa Clinical Research, LLC | Tulsa | Oklahoma | 74104 | United States |
| Cyn3rgy Research | Gresham | Oregon | 97030 | United States |
| Oregon Center for Clinical Investigations Inc | Portland | Oregon | 97210 | United States |
| Summit Research Network | Portland | Oregon | 97210 | United States |
| Oregon Center for Clinical Investigations, Inc | Salem | Oregon | 97301 | United States |
| University Services | West Chester | Pennsylvania | 19380 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Rainbow Research, Inc. | Barnwell | South Carolina | 29812 | United States |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | United States |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | United States |
| Research Across America/Psychiatric Medical Associates | Dallas | Texas | 75234 | United States |
| Bayou City Research | Houston | Texas | 77007 | United States |
| Claghorn-Lesem Research Clinic, Ltd. | Houston | Texas | 77008 | United States |
| Clinical Trial Network | Houston | Texas | 77074 | United States |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | United States |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | United States |
| Houston Clinical Trials, LLC | Houston | Texas | 77098 | United States |
| Westex Clinical Investigations | Lubbock | Texas | 79423 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Univ of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Ericksen Research and Development - Westside Medical | Clinton | Utah | 84015 | United States |
| University of Virginia Child and Family Psychiatry Clinic | Charlottesville | Virginia | 22903 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Eastside Thereapeutic Resource | Kirkland | Washington | 98033 | United States |
| Summit Research Network (Seattle), LLC | Seattle | Washington | 98104 | United States |
| Rockwood Clinic, P.S. | Spokane | Washington | 99202 | United States |
| True North Clinical Research | Kentville | Nova Scotia | B4N 4K9 | Canada |
| The Kids Clinic | Whitby | Ontario | L1N 2L1 | Canada |
| Schwerpunktpraxis fur Entwicklung und Lernen | Bamberg | 96047 | Germany |
| Klinik Fur Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie | Frankfurt | 15236 | Germany |
| Universitatsklinikum Freiburg | Freiburg im Breisgau | 79104 | Germany |
| Kinderarztpraxis Dr. Kaiser und Dr. MarineBe | Hamburg | 22415 | Germany |
| Zentralinstitut fur Seelische Gesundheit | Mannheim | 68159 | Germany |
| Medizinisches Studienzentrum Wurzburg | Würzburg | 97070 | Germany |
| Vadaskert Gyermekpszichiatriai Korhaz es Szakambulancia | Budapest | H-1021 | Hungary |
| Bekes Megyei Pandy Kalman Korhaz | Gyula | H-5700 | Hungary |
| Pecsi Megyei Jogu varos Egyesitett Egeszsegugyi Intezmenyek | Pécs | H-7632 | Hungary |
| Szegedi Tudomanyegyetem | Szeged | H-6725 | Hungary |
| Gillbergcentrum | Gothenburg | 411 19 | Sweden |
| PRIMA Barn-och Vuxenpsykiatri Jarva | Spånga | 163 74 | Sweden |
| FG002 | Methylphenidate | Methylphenidate (Concerta, Osmotic controlled oral release delivery system-methylphenidate [OROS-MPH]) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety set consisted of all participants in the Randomized set (all screened participants for whom a randomization number was generated) who took at least 1 dose of investigational product.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 2 placebo over encapsulated capsules once daily orally for 6 weeks. |
| BG001 | Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance). |
| BG002 | Methylphenidate | Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance). |
| 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, Categorical | Age was calculated as the difference between date of birth and date of informed consent. | Count of Participants | Participants |
| |||||||||||||||
| Age, Continuous | Age was calculated as the difference between date of birth and date of informed consent. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Attention-deficit/Hyperactivity Disorder (ADHD) Subtype | Count of Participants | Participants |
| ||||||||||||||||
| Clinical Global Impressions - Severity of Illness (CGI-S) | The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale includes a severity of illness item and a global improvement item. The investigator performed the CGI-S to rate the severity of a participant'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; or 7=extremely ill). | Count of Participants | Participants |
| |||||||||||||||
| Attention-deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score | The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| 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 Week 6 | The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms. | Full Analysis Set (FAS) was defined as all participants in the Safety set who had at least 1 post-baseline measurement of the ADHD-RS-IV. Not all FAS participants were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 6 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6 | The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale included a severity of illness item and a global improvement item. The investigator performed the CGI-I to rate the improvement of a participant's ADHD symptoms based on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse.). Percentage of participants with an improved measurement (response of very much improved and much improved) is reported. | FAS. | Posted | Number | percentage of participants | Week 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of double-blind investigational product and up to 3 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Safety set. | Posted | Number | participants | Baseline up to 3 days after last dose (last dose at Week 6) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Blood Pressure at Week 6 | Safety set. Not all Safety set participants were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | Baseline, Week 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Pulse Rate at Week 6 | Safety set. Not all Safety set participants were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Beats per minute | Baseline, Week 6 |
|
Baseline up to 3 days after last dose (last dose at Week 6)
AEs occurred during the double-blind evaluation phase were considered as TEAEs if AEs had a start date on or after the first dose of double-blind study drug or a start date before the date of the first dose of double-blind study drug, but increased in severity on or after the date of the first dose of double-blind study drug. Safety Set.
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 | Placebo | 2 placebo over encapsulated capsules once daily orally for 6 weeks. | 1 | 110 | 32 | 110 | ||
| EG001 | Lisdexamfetamine Dimesylate | Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance). | 1 | 218 | 113 | 218 | ||
| EG002 | Methylphenidate | Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance). | 1 | 219 | 99 | 219 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Psychotic episode | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
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
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Predominantly Hyperactive/Impulsive |
|
| Combined Subtype |
|
| Mildly ill |
|
| Moderately ill |
|
| Markedly ill |
|
| Severely ill |
|
| The LSM, the difference in LSM and its 95% CI, and the p-value were from a mixed effects model for repeated measures that included treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on REML method of estimation and utilized an unstructured covariance. | Mixed Models Analysis | < 0.0001 | Difference in LSM | -8.5 | 2-Sided | 95 | -11 | -6 | Superiority or Other (legacy) |
| The LSM, the difference in LSM and its 95% CI, and the p-value were from a mixed effects model for repeated measures that includes treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on REML method of estimation and utilized an unstructured covariance. | Mixed Models Analysis | < 0.0001 | Difference in LSM | -5.1 | 2-Sided | 95 | -7.6 | -2.6 | Superiority or Other (legacy) |
Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance). |
|
|
| OG002 | Methylphenidate | Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance). |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|