Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00746733
Recruitment Status : Completed
First Posted : September 4, 2008
Results First Posted : November 17, 2009
Last Update Posted : November 20, 2009
Sponsor:
Information provided by:
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy Volunteers
Interventions Drug: Lisdexamfetamine Dimesylate
Drug: Adderall XR (mixed salts amphetamine)
Enrollment 24
Recruitment Details  
Pre-assignment Details Open-label, randomized, four period crossover
Arm/Group Title Vyvanse First Adderall XR First
Hide Arm/Group Description Vyvanse 50mg dosed once in the first intervention, Adderall XR 20 mg dosed once in the second intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the third intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the fourth intervention. Adderall XR 20 mg dosed once in the first intervention, Vyvanse 50mg dosed once in the second intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the third intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the fourth intervention.
Period Title: First Intervention
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Second Intervention
Started 12 12
Completed 11 12
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Period Title: Third Intervention
Started 11 12
Completed 10 11
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Period Title: Fourth Intervention
Started 10 11
Completed 10 11
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
24
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
37.7  (6.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
6
  25.0%
Male
18
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Hide Description d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Time Frame 0 through 96 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population defined as all subjects who have evaluable concentration-time profiles.
Arm/Group Title Vyvanse Adderall XR Vyvanse + Prilosec OTC Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 23 21 21
Mean (Standard Deviation)
Unit of Measure: ng/ml
45.04  (13.971) 28.66  (7.174) 46.34  (9.710) 29.97  (5.719)
2.Primary Outcome
Title Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Hide Description d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Time Frame 0 through 96 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Vyvanse Adderall XR Vyvanse + Prilosec OTC Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 23 21 21
Mean (Standard Deviation)
Unit of Measure: h
3.5  (1.14) 5.2  (3.10) 3.5  (0.97) 3.3  (1.45)
3.Primary Outcome
Title Area Under the Steady-state Plasma Concentration-time Curve (AUC) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Hide Description d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Time Frame 0 through 96 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Vyvanse Adderall XR Vyvanse + Prilosec OTC Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 23 21 21
Mean (Standard Deviation)
Unit of Measure: ng.h/ml
626.27  (198.982) 473.70  (71.043) 687.00  (196.906) 472.35  (108.891)
4.Primary Outcome
Title Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Hide Description d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Time Frame 0 through 96 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Vyvanse Adderall XR Vyvanse + Prilosec OTC Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 23 21 21
Mean (Standard Deviation)
Unit of Measure: h
9.7  (1.55) 10.25  (1.36) 10.4  (1.65) 10.91  (1.95)
5.Primary Outcome
Title Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Hide Description l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Time Frame 0 through 96 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Adderall XR Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: ng/ml
7.91  (2.022) 8.10  (1.632)
6.Primary Outcome
Title Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Hide Description l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Time Frame 0 through 96 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Adderall XR Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: h
5.6  (3.0) 3.5  (1.74)
7.Primary Outcome
Title AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Hide Description [Not Specified]
Time Frame 0 through 96 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Adderall XR Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: ng.h/ml
145.28  (24.355) 145.83  (38.233)
8.Primary Outcome
Title T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Hide Description l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Time Frame 0 through 96 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Adderall XR Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: h
11.98  (1.92) 13.06  (2.63)
9.Primary Outcome
Title Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Hide Description Total amphetamine is the d- and l-amphetamines.
Time Frame 0 through 96 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Adderall XR Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: ng/ml
36.56  (9.188) 38.05  (7.351)
10.Primary Outcome
Title Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Hide Description Total amphetamine is the d- and l-amphetamines.
Time Frame 0 through 96 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Adderall XR Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: h
5.30  (3.07) 3.29  (1.45)
11.Primary Outcome
Title AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Hide Description Total amphetamine is the d- and l-amphetamines.
Time Frame 0 through 96 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Adderall XR Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: ng.h/ml
620.68  (95.689) 620.91  (145.378)
12.Primary Outcome
Title T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Hide Description Total amphetamine is the d- and l-amphetamines.
Time Frame 0 through 96 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Adderall XR Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: h
10.38  (1.56) 11.05  (2.22)
13.Secondary Outcome
Title Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
Hide Description Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.
Time Frame Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) population defined as all subjects who have evaluable DRQ-S values reported.
Arm/Group Title Vyvanse + Prilosec OTC Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-dose 1.0  (0.0) 1.0  (0.0)
0.5 h 1.2  (0.60) 2.0  (3.09)
1 h 1.8  (1.75) 2.0  (3.08)
1.5 h 4.6  (8.28) 2.2  (3.56)
2 h 4.6  (8.33) 2.5  (4.56)
2.5 h 3.9  (6.04) 2.3  (3.73)
3 h 3.5  (5.78) 1.5  (1.03)
3.5 h 2.7  (3.78) 1.3  (0.80)
4 h 1.7  (1.06) 1.4  (0.86)
5 h 2.4  (3.93) 1.3  (0.72)
6 h 1.4  (0.81) 1.2  (0.51)
8 h 1.4  (0.74) 1.3  (1.32)
12 h 1.2  (0.62) 1.1  (0.36)
24 h 1.3  (0.72) 1.0  (0.22)
14.Secondary Outcome
Title DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
Hide Description Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.
Time Frame Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PD population
Arm/Group Title Vyvanse + Prilosec OTC Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-dose 1.0  (0.0) 1.0  (0.0)
0.5 h 1.3  (0.73) 1.3  (0.66)
1 h 2.1  (2.66) 1.9  (2.46)
1.5 h 5.2  (8.38) 2.3  (2.97)
2 h 6.0  (8.69) 3.5  (5.33)
2.5 h 6.0  (7.59) 3.5  (4.64)
3 h 5.3  (6.72) 2.7  (3.36)
3.5 h 4.9  (6.09) 2.1  (2.01)
4 h 3.8  (4.57) 2.1  (1.84)
5 h 3.1  (4.13) 1.9  (1.74)
6 h 3.4  (3.60) 1.5  (0.87)
8 h 3.0  (4.26) 1.3  (0.66)
12 h 4.4  (7.19) 1.2  (0.54)
24 h 1.6  (1.40) 1.0  (0.22)
15.Secondary Outcome
Title DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
Hide Description Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.
Time Frame Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PD population
Arm/Group Title Vyvanse + Prilosec OTC Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-dose 1.0  (0.0) 1.0  (0.0)
0.5 h 2.0  (3.49) 2.1  (3.11)
1 h 1.8  (1.67) 2.0  (3.08)
1.5 h 4.3  (8.03) 1.8  (1.55)
2 h 4.5  (8.37) 1.4  (0.93)
2.5 h 3.8  (6.39) 1.4  (0.80)
3 h 3.4  (5.78) 1.2  (0.54)
3.5 h 2.6  (3.54) 1.3  (0.72)
4 h 1.8  (1.18) 1.3  (0.80)
5 h 2.3  (4.13) 1.3  (0.97)
6 h 1.6  (1.02) 1.2  (0.70)
8 h 1.6  (1.78) 1.1  (0.48)
12 h 1.3  (0.80) 1.2  (0.51)
24 h 1.1  (0.48) 1.0  (0.22)
16.Secondary Outcome
Title Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Hide Description [Not Specified]
Time Frame Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population defined as subjects who take at least one dose of investigational medicinal product and have at least one post-dose safety assessment.
Arm/Group Title Vyvanse Adderall XR Vyvanse + Prilosec OTC Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 23 21 21
Mean (Standard Deviation)
Unit of Measure: mmHg
Pre-dose 115.6  (10.79) 115.3  (10.26) 114.8  (11.29) 113.9  (11.71)
1 h 122.8  (11.10) 121.0  (10.46) 121.7  (13.31) 122.6  (9.67)
2 h 127.9  (12.81) 122.2  (11.34) 125.5  (10.14) 124.7  (12.74)
4 h 127.6  (12.95) 120.8  (11.71) 125.2  (11.50) 124.2  (9.75)
8 h 126.0  (12.69) 122.4  (11.04) 123.5  (13.25) 119.2  (10.99)
12 h 123.4  (15.62) 121.9  (12.04) 122.2  (13.19) 118.4  (10.58)
24 h 114.0  (11.68) 118.1  (12.97) 114.7  (11.19) 115.6  (13.42)
48 h 114.6  (12.84) 112.6  (10.56) 114.4  (10.81) 113.6  (11.01)
72 h 113.7  (10.25) 114.8  (11.81) 115.1  (11.71) 116.0  (9.74)
96 h 114.0  (10.53) 114.5  (10.72) 114.8  (11.06) 116.1  (9.29)
17.Secondary Outcome
Title Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Hide Description [Not Specified]
Time Frame Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Vyvanse Adderall XR Vyvanse + Prilosec OTC Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 23 21 21
Mean (Standard Deviation)
Unit of Measure: mmHg
Pre-dose 76.0  (6.68) 74.1  (6.72) 77.7  (8.60) 75.8  (7.80)
1 h 79.2  (6.62) 76.4  (5.98) 80.5  (9.52) 80.4  (6.29)
2 h 79.0  (6.97) 75.4  (6.58) 82.0  (6.44) 81.9  (8.71)
4 h 79.9  (7.91) 77.7  (6.31) 82.0  (7.68) 82.0  (7.09)
8 h 78.6  (7.87) 74.1  (5.73) 80.3  (9.54) 79.2  (7.96)
12 h 79.6  (9.45) 78.5  (8.29) 78.7  (10.47) 77.8  (8.20)
24 h 75.9  (6.76) 76.8  (8.62) 75.0  (7.76) 75.4  (7.30)
48 h 74.5  (8.39) 73.5  (8.40) 77.2  (6.53) 74.4  (8.01)
72 h 75.1  (7.97) 74.7  (7.24) 76.1  (7.58) 77.9  (6.77)
96 h 74.5  (8.02) 75.7  (7.65) 75.7  (7.48) 78.3  (6.96)
18.Secondary Outcome
Title Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Hide Description [Not Specified]
Time Frame Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Vyvanse Adderall XR Vyvanse + Prilosec OTC Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 23 21 21
Mean (Standard Deviation)
Unit of Measure: bpm
Pre-dose 70.9  (9.87) 69.0  (8.87) 73.3  (10.16) 71.4  (10.14)
1 h 69.7  (10.61) 70.0  (11.29) 73.4  (10.91) 73.8  (13.78)
2 h 78.2  (11.64) 75.2  (10.85) 83.4  (14.68) 80.5  (16.87)
4 h 79.0  (14.40) 74.5  (12.62) 84.4  (16.29) 78.4  (15.03)
8 h 84.8  (11.38) 79.1  (10.70) 87.7  (14.34) 81.5  (11.50)
12 h 86.4  (13.84) 82.3  (14.12) 89.1  (13.77) 82.7  (10.99)
24 h 79.9  (11.19) 74.7  (12.58) 80.4  (11.32) 76.4  (12.06)
48 h 73.2  (11.28) 74.0  (11.02) 75.1  (10.32) 75.0  (9.46)
72 h 72.2  (10.63) 73.3  (9.16) 72.0  (7.99) 72.7  (8.78)
96 h 70.7  (10.64) 70.4  (9.11) 72.5  (10.12) 73.9  (9.86)
19.Secondary Outcome
Title Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Hide Description QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Time Frame Pre-dose, 2 and 8 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Vyvanse Adderall XR Vyvanse + Prilosec OTC Adderall XR + Prilosec OTC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 23 21 21
Mean (Standard Deviation)
Unit of Measure: msec
Pre-dose 399.8  (14.55) 398.3  (15.24) 399.3  (13.38) 399.8  (15.04)
2 h 395.0  (14.11) 394.6  (13.42) 397.9  (13.86) 396.1  (14.49)
8 h 390.0  (12.45) 393.8  (13.94) 395.4  (14.93) 394.4  (13.26)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vyvanse Adderall XR Vyvanse + Prilosec OTC Adderall XR + Prilosec OTC
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Vyvanse Adderall XR Vyvanse + Prilosec OTC Adderall XR + Prilosec OTC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vyvanse Adderall XR Vyvanse + Prilosec OTC Adderall XR + Prilosec OTC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/23 (0.00%)      0/21 (0.00%)      0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vyvanse Adderall XR Vyvanse + Prilosec OTC Adderall XR + Prilosec OTC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/24 (33.33%)      3/23 (13.04%)      10/21 (47.62%)      3/21 (14.29%)    
Cardiac disorders         
Palpitations  2/24 (8.33%)  2 1/23 (4.35%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Tachycardia  2/24 (8.33%)  2 0/23 (0.00%)  0 0/21 (0.00%)  0 0/21 (0.00%)  0
Nervous system disorders         
Dizziness  1/24 (4.17%)  1 0/23 (0.00%)  0 2/21 (9.52%)  2 0/21 (0.00%)  0
Headache  1/24 (4.17%)  1 0/23 (0.00%)  0 3/21 (14.29%)  3 0/21 (0.00%)  0
Psychiatric disorders         
Anxiety  2/24 (8.33%)  2 2/23 (8.70%)  2 8/21 (38.10%)  9 0/21 (0.00%)  0
Vascular disorders         
Vasospasm  0/24 (0.00%)  0 0/23 (0.00%)  0 4/21 (19.05%)  4 3/21 (14.29%)  3
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
Name/Title: Gerald Tremblay, M.D.
Organization: Shire Pharmaceuticals
Responsible Party: Gerald Tremblay, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier: NCT00746733     History of Changes
Other Study ID Numbers: SPD489-113
First Submitted: September 2, 2008
First Posted: September 4, 2008
Results First Submitted: October 14, 2009
Results First Posted: November 17, 2009
Last Update Posted: November 20, 2009