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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 of optimized dose, ranging from 30- 70 mg. 5 week dose optimization, 3 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 8 | 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. Higher score indicates more severe symptoms. | Baseline and week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - 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. | Week 8 |
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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 |
|---|---|---|---|---|---|---|
| Melmed Center | Scottsdale | Arizona | 85254 | United States | ||
| Clinical Study Centers, LLC |
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules. |
| FG001 | SPD489 | Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Methylphenidate Hydrochloride | Drug | Daily oral dosing in the AM of optimized dose, ranging from 18-72 mg. 5 week dose optimization, 3 week dose maintenance |
|
|
| Placebo | Drug | Daily oral dosing in the AM for 8 weeks |
|
| Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment | Baseline and up to 8 Weeks |
| Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment | Baseline and up to 8 weeks |
| Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment | Baseline and up to 8 weeks |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Synergy Clinical Research Center | National City | California | 91950 | United States |
| Pacific Clinical Research Medical Group | Orange | California | 92868 | United States |
| SDS Clinical Trials, Inc. | Orange | California | 92868 | United States |
| Peninsula Research Associates, Inc. | 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 |
| Neuropsychiatric Research Center of Orange County | Santa Ana | California | 92701 | United States |
| Elite Clinical Trials | Wildomar | California | 92595 | United States |
| MCB Clinical Research Centers, LLC | Colorado Springs | Colorado | 80910 | United States |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34201 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32608 | United States |
| Amedica Research Institute | Hialeah | Florida | 33013 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Fidelity Clinical Research, Inc. | Lauderhill | Florida | 33319 | United States |
| Florida Clinical Research Center, LLC | Maitland | Florida | 32751 | United States |
| Scientific Clinical Research, Inc. | Miami | Florida | 33161 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32806 | United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| Stedman Clinical Trials | Tampa | Florida | 33613 | United States |
| Janus Center for Psychiatric Research | West Palm Beach | Florida | 33407 | United States |
| Atlanta Institute of Medicine and Research | Atlanta | Georgia | 30328 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| AMR Baber Research Group, Inc. | Naperville | Illinois | 60563 | United States |
| AMR Conventions Research | Naperville | Illinois | 60563 | United States |
| American Medical Research, Inc | Oak Brook | Illinois | 60523 | United States |
| Advocate Hope Children's Hospital | Oak Lawn | Illinois | 60453 | United States |
| Neuroscience Research Institute, Inc | Oak Park | Illinois | 60301 | United States |
| Psychiatric Associates | Overland Park | Kansas | 66211 | United States |
| University of Kentucky | Lexington | Kentucky | 40509 | United States |
| Four Rivers Clinical Research | Paducah | Kentucky | 42003 | United States |
| Neuroscientific InSights | Rockville | Maryland | 20852 | United States |
| Marc Hertzman MD, PC | Rockville | Maryland | 20882 | 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 |
| Precise Research Centers | Flowood | Mississippi | 39232 | United States |
| Comprehensive Psychiatric Associates | Gladstone | Missouri | 64118 | United States |
| St Charles Psychiatric Associates | Saint Charles | Missouri | 63301 | United States |
| Premier Psychiatric Research Institute | Lincoln | Nebraska | 68526 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68105 | United States |
| Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada | 89128 | United States |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| CRCNJ - Clinical Research Center of New Jersey | Gibbsboro | New Jersey | 08026 | United States |
| Neurcognitive Institute | Mount Arlington | New Jersey | 07856 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Duke Child and Family Study Center | Durham | North Carolina | 27705 | United States |
| Innovis Health, LLC | Fargo | North Dakota | 58103 | United States |
| North Coast Clinical Trials | Beachwood | Ohio | 44122 | United States |
| University of Cincinnati Dept. of Psychiatry & Behavioral | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Nisonger Center | Columbus | Ohio | 43210 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| Professional Psychiatric Services | Mason | Ohio | 45040 | United States |
| Family Practice of Wadsworth, Inc. | Wadsworth | Ohio | 44281 | United States |
| Cyn3rgy Research | Gresham | Oregon | 97030 | United States |
| Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.) | Portland | Oregon | 97210 | United States |
| Summit Research Network (Oregon) Inc. | Portland | Oregon | 97210 | United States |
| Oregon Center for Clinical Investigations, Inc. | Salem | Oregon | 97301 | United States |
| Carolina Clinical Trials, Inc. | Charleston | South Carolina | 29407 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Research Strategies of Memphis, LLC | Memphis | Tennessee | 38119 | United States |
| FutureSearch Trials | Austin | Texas | 78731 | United States |
| Claghorn-Lesem Reseach Clinic, Ltd. | Houston | Texas | 77008 | United States |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | United States |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | United States |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | 77586 | United States |
| Westex Clinical Investigations | Lubbock | Texas | 79423 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| University of Texas HSC at San Antonio Dept. of Psychiatry | San Antonio | Texas | 78229 | United States |
| Wharton Research Center, Inc. | Wharton | Texas | 77488 | United States |
| Psychiatric & Behavioral Solutions | Salt Lake City | Utah | 84105 | United States |
| University of Virginia Child and Family Psychiatry Clinical | Charlottesville | Virginia | 22903 | United States |
| NeuroScience, Inc. | Herndon | Virginia | 20170 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Eastside Therapeutic 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 |
| FG002 | OROS-MPH | Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety Set: All subjects in the Randomized Set who took at least 1 dose of investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules. |
| BG001 | SPD489 | Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day. |
| BG002 | OROS-MPH | Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets. |
| 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 | Mean | Standard Deviation | Years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| 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 Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8 | 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. Higher score indicates more severe symptoms. | Full Analysis Set: All subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline primary efficacy assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and week 8 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - 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: All subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline primary efficacy assessment. | Posted | Number | percentage of participants | Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment | Safety Set: All randomized subjects who took at least 1 dose of investigational product. | Posted | Mean | Standard Deviation | mmHg | Baseline and up to 8 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment | Safety Set: All randomized subjects who took at least 1 dose of investigational product. | Posted | Mean | Standard Deviation | mmHg | Baseline and up to 8 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment | Safety Set: All randomized subjects who took at least 1 dose of investigational product. | Posted | Mean | Standard Deviation | bpm | Baseline and up to 8 weeks |
|
|
Duration of the study, for up to 8 weeks per participant
Treatment-Emergent Adverse Events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules. | 0 | 91 | 39 | 91 | ||
| EG001 | SPD489 | Subjects received over encapsulated SPD489 optimized among a 30, 50, or 70mg dose. | 1 | 184 | 139 | 184 | ||
| EG002 | OROS-MPH | Subjects received over encapsulated OROS-MPH optimized among a 18, 36, 54 or 72mg dose. Subjects optimized to 72mg received two 36mg tablets. | 1 | 184 | 120 | 184 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders |
| |||
| Renal cyst | Renal and urinary disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders |
| |||
| Dry mouth | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Fatigue | General disorders |
| |||
| Irritability | General disorders |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Upper respiratory tract infection | Infections and infestations |
| |||
| Heart rate increased | Investigations |
| |||
| Weight decreased | Investigations |
| |||
| Decreased appetite | Metabolism and nutrition disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Somnolence | Nervous system disorders |
| |||
| Initial insomnia | Psychiatric 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 |
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| 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 |
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| Male |
|
| <0.0001 |
| Difference in LS Mean |
| -12.2 |
| Standard Error of the Mean |
| 1.45 |
| 2-Sided |
| 95 |
| -15.1 |
| -9.4 |
| Superiority or Other (legacy) |
| mixed effects model for repeated measure | <0.0001 | Difference in LS Mean | -10.1 | Standard Error of the Mean | 1.43 | 2-Sided | 95 | -13.0 | -7.3 | Superiority or Other (legacy) |
| Units | Counts |
|---|
| Participants |
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