Attention-deficit/Hyperactivity DisorderPhase 4NCT01552915

Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

A Phase 4 study testing Lisdexamfetamine dimesylate and Methylphenidate Hydrochloride in people with Attention-deficit/Hyperactivity Disorder, run by Shire at 79 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD). Read more about this study

Who is it for?: Ages 13 to 17 years
Conditions the study is for: Attention-deficit/Hyperactivity Disorder
What is being tested?: Lisdexamfetamine dimesylate and Methylphenidate Hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 464 participants
Where: 79 sitesUnited States
Study dates: 17 Apr 2012to 22 Jan 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Subject must be 13-17 years of age, inclusive, at the time of consent.
Subject must weigh more than 79.5lb.
The parent/LAR must be available at approximately 7:00AM (±2 hours) to dispense the dose of investigational product for the study duration.
Subject, who is a female, must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements of the protocol.
Subject has an ADHD-RS-IV total score ≥28.
Subject is able to swallow a capsule.
Subject does not have hypertension and has a resting sitting blood pressure less than or equal to 135/85mmHg.

Who cannot join

Subject has a current, controlled (with medications prohibited in this study) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any significant comorbid Axis II disorder or significant Axis I disorder (such as post traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, depressive or anxiety disorder.
Diagnosis of conduct disorder. Oppositional defiant disorder is not exclusionary.
Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded.
Subject is underweight or overweight.
Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition. Mild, stable asthma is not exclusionary.
Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.

Show all 21Show fewer

Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place him/her at increased vulnerability to the sympathomimetic effects of a stimulant medication.
Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
Subject has any clinically significant ECG or clinically significant laboratory abnormality.
Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone (TSH) and thyroxine (T4). Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.
Subject has a documented allergy, hypersensitivity, or intolerance to MPH or to any excipients in the reference product.
Subject has failed to fully respond to an adequate course(s) (dose and duration) of MPH or amphetamine therapy.
Subject has a history of suspected substance abuse or dependence disorder (excluding nicotine). Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded.
Subject has a positive urine drug result.
Subject has previously participated in this study or another clinical study involving SPD489/NRP104.
Subject has glaucoma.
Subject is required to take or anticipates the need to take medications that have CNS effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors. Stable use of bronchodilator inhalers is not exclusionary.
Subject is female and is pregnant or lactating.
Subject is well controlled on his/her current ADHD medication.
Subject has a pre-existing severe gastrointestinal tract narrowing.

Trial locations and contacts

79 sites in 1 country.

City, postcode or hospital

79 sites in 1 country

United States79 sites

Atlanta Institute of Medicine and Research
Atlanta, Georgia, 30328
FutureSearch Trials
Austin, Texas, 78731
North Coast Clinical Trials
Beachwood, Ohio, 44122
Northwest Clinical Research Center
Bellevue, Washington, 98007
Florida Clinical Research Center, LLC
Bradenton, Florida, 34201
Carolina Clinical Trials, Inc.
Charleston, South Carolina, 29407
University of Virginia Child and Family Psychiatry Clinical
Charlottesville, Virginia, 22903
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
University of Cincinnati Dept. of Psychiatry & Behavioral
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910
The Ohio State University Nisonger Center
Columbus, Ohio, 43210
Midwest Clinical Research Center
Dayton, Ohio, 45417
Duke Child and Family Study Center
Durham, North Carolina, 27705
Innovis Health, LLC
Fargo, North Dakota, 58103
Precise Research Centers
Flowood, Mississippi, 39232
Sarkis Clinical Trials
Gainesville, Florida, 32608
CRCNJ - Clinical Research Center of New Jersey
Gibbsboro, New Jersey, 08026
Comprehensive Psychiatric Associates
Gladstone, Missouri, 64118
Cyn3rgy Research
Gresham, Oregon, 97030
NeuroScience, Inc.
Herndon, Virginia, 20170
Amedica Research Institute
Hialeah, Florida, 33013
Claghorn-Lesem Reseach Clinic, Ltd.
Houston, Texas, 77008
Texas Center for Drug Development, Inc.
Houston, Texas, 77081
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Eastside Therapeutic Resource
Kirkland, Washington, 98033
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77586
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
Fidelity Clinical Research, Inc.
Lauderhill, Florida, 33319
University of Kentucky
Lexington, Kentucky, 40509
Capstone Clinical Research
Libertyville, Illinois, 60048
Premier Psychiatric Research Institute
Lincoln, Nebraska, 68526
Clinical Study Centers, LLC
Little Rock, Arkansas, 72211
Westex Clinical Investigations
Lubbock, Texas, 79423
Florida Clinical Research Center, LLC
Maitland, Florida, 32751
Professional Psychiatric Services
Mason, Ohio, 45040
Research Strategies of Memphis, LLC
Memphis, Tennessee, 38119
Scientific Clinical Research, Inc.
Miami, Florida, 33161
Neurcognitive Institute
Mount Arlington, New Jersey, 07856
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
AMR Baber Research Group, Inc.
Naperville, Illinois, 60563
AMR Conventions Research
Naperville, Illinois, 60563
Synergy Clinical Research Center
National City, California, 91950
Mount Sinai School of Medicine
New York, New York, 10029
American Medical Research, Inc
Oak Brook, Illinois, 60523
Advocate Hope Children's Hospital
Oak Lawn, Illinois, 60453
Neuroscience Research Institute, Inc
Oak Park, Illinois, 60301
University of Nebraska Medical Center
Omaha, Nebraska, 68105
Pacific Clinical Research Medical Group
Orange, California, 92868
SDS Clinical Trials, Inc.
Orange, California, 92868
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806
Compass Research, LLC
Orlando, Florida, 32806
Psychiatric Associates
Overland Park, Kansas, 66211
Four Rivers Clinical Research
Paducah, Kentucky, 42003
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
Portland, Oregon, 97210
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
Neuroscientific InSights
Rockville, Maryland, 20852
Marc Hertzman MD, PC
Rockville, Maryland, 20882
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, 90274
St Charles Psychiatric Associates
Saint Charles, Missouri, 63301
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, 97301
Psychiatric & Behavioral Solutions
Salt Lake City, Utah, 84105
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
University of Texas HSC at San Antonio Dept. of Psychiatry
San Antonio, Texas, 78229
PCSD - Feighner Research
San Diego, California, 92108
University of California, San Francisco
San Francisco, California, 94143
Neuropsychiatric Research Center of Orange County
Santa Ana, California, 92701
Melmed Center
Scottsdale, Arizona, 85254
Summit Research Network (Seattle), LLC
Seattle, Washington, 98104
Rockwood Clinic, P.S.
Spokane, Washington, 99202
Clinical Neurophysiology Services, PC
Sterling Heights, Michigan, 48314
Stedman Clinical Trials
Tampa, Florida, 33613
Behavioral Medical Center - Troy
Troy, Michigan, 48083
Family Practice of Wadsworth, Inc.
Wadsworth, Ohio, 44281
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407
Wharton Research Center, Inc.
Wharton, Texas, 77488
Elite Clinical Trials
Wildomar, California, 92595

Other trials in United States

About this study

Official title: A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Dose-optimization Safety and Efficacy Study of SPD489 (VYVANSE®) Compared With OROS-MPH (CONCERTA®) With a Placebo Reference Arm, in Adolescents Aged 13-17 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).

Conditions: Attention-deficit/Hyperactivity Disorder
Being tested: Lisdexamfetamine dimesylate, Methylphenidate Hydrochloride, Placebo
Keywords: ADHD
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lisdexamfetamine dimesylateDrug
Also called LDX, Vyvanse, SPD489
Daily oral dosing in the AM of optimized dose, ranging from 30- 70 mg. 5 week dose optimization, 3 week dose maintenance
Methylphenidate HydrochlorideDrug
Also called OROS-MPH, Concerta
Daily oral dosing in the AM of optimized dose, ranging from 18-72 mg. 5 week dose optimization, 3 week dose maintenance
PlaceboDrug
Daily oral dosing in the AM for 8 weeks

Study groups in NCT01552915
Study group	Role	What they receive
Lisdexamfetamine Dimesylate	Experimental	Not described Receives: Drug: Lisdexamfetamine dimesylate
Methylphenidate Hydrochloride	Active comparator	Not described Receives: Drug: Methylphenidate Hydrochloride
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and week 8

Secondary outcomes (4)

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.
Measured: Week 8
Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
Measured: Baseline and up to 8 Weeks
Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
Measured: Baseline and up to 8 weeks
Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment
Measured: Baseline and up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 201222 Jan 2014

First posted13 Mar 2012 (estimated)
Study start17 Apr 2012
Primary completion22 Jan 2014
Study completion22 Jan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Attention-deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 464 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01552915
Sponsor's protocol ID: SPD489-405
Status last verified: May 2021
First submitted: 6 Mar 2012
Last updated: 8 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 28980198

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
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All Attention-deficit/Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Dose-optimization Safety and Efficacy Study of SPD489 (VYVANSE®) Compared With OROS-MPH (CONCERTA®) With a Placebo Reference Arm, in Adolescents Aged 13-17 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
ClinicalTrials.gov ID: NCT01552915
Acronym / sponsor ID: SPD489-405
Conditions: Attention-deficit/Hyperactivity Disorder
Keywords: ADHD
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 464 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 17 Apr 2012 (actual)
Primary completion: 22 Jan 2014 (actual)
Study completion: 22 Jan 2014 (actual)
First posted: 13 Mar 2012 (estimated)
Results: Posted 11 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Lisdexamfetamine Dimesylate	Experimental	Drug: Lisdexamfetamine dimesylate
Methylphenidate Hydrochloride	Active comparator	Drug: Methylphenidate Hydrochloride
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 13 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

Subject must be 13-17 years of age, inclusive, at the time of consent.
Subject must weigh more than 79.5lb.
The parent/LAR must be available at approximately 7:00AM (±2 hours) to dispense the dose of investigational product for the study duration.
Subject, who is a female, must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements of the protocol.
Subject has an ADHD-RS-IV total score ≥28.

Key exclusion criteria (21 listed)

Subject has a current, controlled (with medications prohibited in this study) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any significant comorbid Axis II disorder or significant Axis I disorder (such as post traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, depressive or anxiety disorder.
Diagnosis of conduct disorder. Oppositional defiant disorder is not exclusionary.
Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded.
Subject is underweight or overweight.
Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition. Mild, stable asthma is not exclusionary.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lisdexamfetamine dimesylateAlso: LDX, Vyvanse, SPD489Daily oral dosing in the AM of optimized dose, ranging from 30- 70 mg. 5 week dose optimization, 3 week dose maintenance	Drug	Lisdexamfetamine Dimesylate
Methylphenidate HydrochlorideAlso: OROS-MPH, ConcertaDaily oral dosing in the AM of optimized dose, ranging from 18-72 mg. 5 week dose optimization, 3 week dose maintenance	Drug	Methylphenidate Hydrochloride
PlaceboDaily oral dosing in the AM for 8 weeks	Drug	Placebo

Primary outcome

Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8
Time frame: Baseline and 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.

4 secondary outcomes

Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF)
Time frame: Week 8
Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
Time frame: Baseline and up to 8 Weeks
Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
Time frame: Baseline and up to 8 weeks
Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment
Time frame: Baseline and up to 8 weeks

Results and safety

Results posted to the registry on 11 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	91	68
SPD489	184	155
OROS-MPH	184	157

Primary outcome: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8

Time frame: Baseline and week 8. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 89	SPD489 n = 179	OROS-MPH n = 184
Value	-13.4 (1.19)	-25.6 (0.82)	-23.5 (0.80)

SPD489 vs OROS-MPH: Difference in LS Mean: -2.1 (95% CI -4.3 to 0.2), p = 0.0717, mixed effects model for repeated measure
Placebo vs SPD489: Difference in LS Mean: -12.2 (95% CI -15.1 to -9.4), p <0.0001, mixed effects model for repeated measure
Placebo vs OROS-MPH: Difference in LS Mean: -10.1 (95% CI -13.0 to -7.3), p <0.0001, mixed effects model for repeated measure

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Duration of the study, for up to 8 weeks per participant. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 91 (0%)	39 of 91 (42.9%)	Not reported
SPD489	1 of 184 (0.5%)	139 of 184 (75.5%)	Not reported
OROS-MPH	1 of 184 (0.5%)	120 of 184 (65.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28980198Newcorn 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.

Related trials for Attention-deficit/Hyperactivity Disorder

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

79 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lisdexamfetamine dimesylate and Methylphenidate Hydrochloride in people with Attention-deficit/Hyperactivity Disorder, run by Shire at 79 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8 (time frame: Baseline and week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01552915, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.