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

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ClinicalTrials.gov Identifier: NCT01552915
Recruitment Status : Completed
First Posted : March 13, 2012
Results First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention-deficit/Hyperactivity Disorder
Interventions Drug: Lisdexamfetamine dimesylate
Drug: Methylphenidate Hydrochloride
Drug: Placebo
Enrollment 464
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo SPD489 OROS-MPH
Hide Arm/Group Description Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules. Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day 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.
Period Title: Overall Study
Started 91 [1] 184 [1] 184 [2]
Completed 68 155 157
Not Completed 23 29 27
Reason Not Completed
Adverse Event             3             14             3
Lost to Follow-up             4             6             5
Withdrawal by Subject             6             4             5
Protocol Violation             0             4             4
Lack of Efficacy             8             1             4
Not specified             2             0             6
[1]
This population is from the Safety Set. Two randomized subjects were not dosed and were excluded.
[2]
This population is from the Safety Set. One randomized subject was not dosed and was excluded.
Arm/Group Title Placebo SPD489 OROS-MPH Total
Hide Arm/Group Description Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules. Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day. 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. Total of all reporting groups
Overall Number of Baseline Participants 91 184 184 459
Hide Baseline Analysis Population Description
Safety Set: All subjects in the Randomized Set who took at least 1 dose of investigational product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 91 participants 184 participants 184 participants 459 participants
14.8  (1.43) 14.7  (1.38) 14.7  (1.32) 14.7  (1.37)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
<=18 years Number Analyzed 91 participants 184 participants 184 participants 459 participants
91 184 184 459
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 184 participants 184 participants 459 participants
Female
30
  33.0%
62
  33.7%
62
  33.7%
154
  33.6%
Male
61
  67.0%
122
  66.3%
122
  66.3%
305
  66.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
UNITED STATES Number Analyzed 91 participants 184 participants 184 participants 459 participants
91 184 184 459
1.Primary Outcome
Title Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8
Hide Description 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.
Time Frame Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo SPD489 OROS-MPH
Hide Arm/Group Description:
Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
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.
Overall Number of Participants Analyzed 89 179 184
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-13.4  (1.19) -25.6  (0.82) -23.5  (0.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPD489, OROS-MPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0717
Comments [Not Specified]
Method mixed effects model for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-4.3 to 0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, SPD489
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method mixed effects model for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -12.2
Confidence Interval (2-Sided) 95%
-15.1 to -9.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.45
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, OROS-MPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method mixed effects model for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -10.1
Confidence Interval (2-Sided) 95%
-13.0 to -7.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.43
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF)
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo SPD489 OROS-MPH
Hide Arm/Group Description:
Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
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.
Overall Number of Participants Analyzed 89 178 184
Measure Type: Number
Unit of Measure: percentage of participants
34.8 83.1 81.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPD489, OROS-MPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6165
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, SPD489
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, OROS-MPH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
Hide Description [Not Specified]
Time Frame Baseline and up to 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set: All randomized subjects who took at least 1 dose of investigational product.
Arm/Group Title Placebo SPD489 OROS-MPH
Hide Arm/Group Description:
Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
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.
Overall Number of Participants Analyzed 89 179 184
Mean (Standard Deviation)
Unit of Measure: mmHg
-0.8  (8.97) 2.4  (9.46) 0.4  (9.90)
4.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
Hide Description [Not Specified]
Time Frame Baseline and up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set: All randomized subjects who took at least 1 dose of investigational product.
Arm/Group Title Placebo SPD489 OROS-MPH
Hide Arm/Group Description:
Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
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.
Overall Number of Participants Analyzed 89 179 184
Mean (Standard Deviation)
Unit of Measure: mmHg
-1.2  (8.11) 2.8  (8.41) 2.2  (8.64)
5.Secondary Outcome
Title Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment
Hide Description [Not Specified]
Time Frame Baseline and up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set: All randomized subjects who took at least 1 dose of investigational product.
Arm/Group Title Placebo SPD489 OROS-MPH
Hide Arm/Group Description:
Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
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.
Overall Number of Participants Analyzed 89 179 184
Mean (Standard Deviation)
Unit of Measure: bpm
0.3  (11.32) 4.7  (11.82) 6.0  (10.52)
Time Frame Duration of the study, for up to 8 weeks per participant
Adverse Event Reporting Description Treatment-Emergent Adverse Events
 
Arm/Group Title Placebo SPD489 OROS-MPH
Hide Arm/Group Description Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules. Subjects received over encapsulated SPD489 optimized among a 30, 50, or 70mg dose. Subjects received over encapsulated OROS-MPH optimized among a 18, 36, 54 or 72mg dose. Subjects optimized to 72mg received two 36mg tablets.
All-Cause Mortality
Placebo SPD489 OROS-MPH
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo SPD489 OROS-MPH
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/91 (0.00%)      1/184 (0.54%)      1/184 (0.54%)    
Psychiatric disorders       
Suicidal ideation  0/91 (0.00%)  0 1/184 (0.54%)  1 0/184 (0.00%)  0
Renal and urinary disorders       
Renal cyst  0/91 (0.00%)  0 0/184 (0.00%)  0 1/184 (0.54%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo SPD489 OROS-MPH
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/91 (42.86%)      139/184 (75.54%)      120/184 (65.22%)    
Gastrointestinal disorders       
Abdominal pain upper  4/91 (4.40%)  6 12/184 (6.52%)  12 10/184 (5.43%)  13
Dry mouth  1/91 (1.10%)  1 15/184 (8.15%)  17 11/184 (5.98%)  11
Nausea  4/91 (4.40%)  4 14/184 (7.61%)  14 15/184 (8.15%)  17
General disorders       
Fatigue  3/91 (3.30%)  3 10/184 (5.43%)  10 5/184 (2.72%)  5
Irritability  9/91 (9.89%)  9 37/184 (20.11%)  41 14/184 (7.61%)  17
Infections and infestations       
Nasopharyngitis  1/91 (1.10%)  1 11/184 (5.98%)  12 13/184 (7.07%)  13
Upper respiratory tract infection  8/91 (8.79%)  9 9/184 (4.89%)  9 6/184 (3.26%)  6
Investigations       
Heart rate increased  0/91 (0.00%)  0 8/184 (4.35%)  8 11/184 (5.98%)  12
Weight decreased  1/91 (1.10%)  1 37/184 (20.11%)  43 24/184 (13.04%)  26
Metabolism and nutrition disorders       
Decreased appetite  7/91 (7.69%)  8 98/184 (53.26%)  118 77/184 (41.85%)  85
Nervous system disorders       
Dizziness  1/91 (1.10%)  1 12/184 (6.52%)  13 8/184 (4.35%)  9
Headache  7/91 (7.69%)  8 28/184 (15.22%)  38 28/184 (15.22%)  35
Somnolence  4/91 (4.40%)  5 10/184 (5.43%)  10 6/184 (3.26%)  6
Psychiatric disorders       
Initial insomnia  2/91 (2.20%)  2 15/184 (8.15%)  17 12/184 (6.52%)  16
Insomnia  0/91 (0.00%)  0 16/184 (8.70%)  17 15/184 (8.15%)  15
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Physician
Organization: Shire Development LLC
Phone: +1 866 842 5335
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01552915     History of Changes
Other Study ID Numbers: SPD489-405
First Submitted: March 6, 2012
First Posted: March 13, 2012
Results First Submitted: December 3, 2014
Results First Posted: December 11, 2014
Last Update Posted: December 11, 2014