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Trial record 49 of 75 for:    AMPHETAMINE AND DEXTROAMPHETAMINE

Co-Administration of LDX (SPD489) and Venlafaxine XR (EFFEXOR XR) in Healthy Volunteers

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: NCT01235338
Recruitment Status : Completed
First Posted : November 5, 2010
Results First Posted : December 8, 2011
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: LDX + Venlafaxine XR
Drug: Venlafaxine XR + LDX
Enrollment 80
Recruitment Details  
Pre-assignment Details Of the 80 randomized subjects, 3 did not receive any investigational product and therefore were not included in the Safety Analysis/Pharmacokinetic Analysis Sets (n = 77).
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
Hide Arm/Group Description LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38. Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Period Title: Overall Study
Started 42 38
Completed 31 33
Not Completed 11 5
Reason Not Completed
Adverse Event             3             2
Protocol Violation             1             1
Withdrawal by Subject             5             0
Exclusion criteria violations             1             1
Positive drug screen             0             1
Prohibited meds             1             0
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX Total
Hide Arm/Group Description LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38. Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38. Total of all reporting groups
Overall Number of Baseline Participants 40 37 77
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 37 participants 77 participants
33.2  (7.01) 33.8  (7.29) 33.5  (7.10)
[1]
Measure Description: The Safety Analysis Set (n = 77) was used to calculate Baseline Measures. The Safety Analysis Set is defined as all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment. 80 subjects were enrolled but 3 never received investigational product.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Between 18 and 45 years Number Analyzed 40 participants 37 participants 77 participants
40 37 77
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 37 participants 77 participants
Female
12
  30.0%
10
  27.0%
22
  28.6%
Male
28
  70.0%
27
  73.0%
55
  71.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 37 participants 77 participants
40 37 77
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate
Hide Description Lisdexamfetamine dimesylate (SPD489) itself is inactive, but following oral administration is converted to the active isomer, d-amphetamine, that is responsible for the drug's therapeutic activity.
Time Frame Day 15 and Day 30 (24 hour sampling)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set (PAS) defined as all subjects who took a t least 1 dose of investigational product and had at least 1 post-dose safety assessment and who had no major deviations related to investigational product intake (e.g. vomiting) and for whom the primary pharmacokinetic data were considered sufficient and interpretable.
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
Hide Arm/Group Description:
LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: ng/ml
Day 15 49.06  (32.25) 0  (0)
Day 30 49.84  (34.3) 50.77  (19.68)
2.Primary Outcome
Title Cmax of d-Amphetamine
Hide Description d-Amphetamine is the active isomer of Lisdexamfetamine dimesylate (SPD489) and is responsible for the drug's therapeutic activity.
Time Frame Day 15 and Day 30 (24 hour sampling)
Hide Outcome Measure Data
Hide Analysis Population Description
PAS
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
Hide Arm/Group Description:
LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: ng/ml
Day 15 88.91  (26.87) 0  (0)
Day 30 88.91  (22.72) 85.27  (20.55)
3.Primary Outcome
Title Cmax of Venlafaxine Hydrochloride
Hide Description Venlafaxine Hydrochloride is the active ingredient of Effexor XR
Time Frame Day 15 and Day 30 (24 hour sampling)
Hide Outcome Measure Data
Hide Analysis Population Description
PAS
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
Hide Arm/Group Description:
LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: ng/ml
Day 15 0  (0) 210.98  (120.6)
Day 30 198.5  (105.48) 228.89  (124.42)
4.Primary Outcome
Title Cmax of o-Desmethylvenlafaxine
Hide Description Venlafaxine, after oral administration, is metabolized in the liver to an active metabolite, o-Desmethylvenlafaxine.
Time Frame Day 15 and Day 30 (24 hour sampling)
Hide Outcome Measure Data
Hide Analysis Population Description
PAS
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
Hide Arm/Group Description:
LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: ng/ml
Day 15 0  (0) 420.55  (139.67)
Day 30 413.71  (149.97) 371.54  (104.92)
5.Primary Outcome
Title Cmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)
Hide Description [Not Specified]
Time Frame Day 15 and Day 30 (24 hour sampling)
Hide Outcome Measure Data
Hide Analysis Population Description
PAS
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
Hide Arm/Group Description:
LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: ng/ml
Day 15 0  (0) 624.56  (179.7)
Day 30 603.49  (181.32) 588.68  (158.79)
6.Primary Outcome
Title Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate
Hide Description [Not Specified]
Time Frame Day 15 and Day 30 (24 hour sampling)
Hide Outcome Measure Data
Hide Analysis Population Description
PAS
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
Hide Arm/Group Description:
LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: ng*hr/ml
Day 15 65.5  (44.0) 0  (0)
Day 30 63.9  (43.7) 60.8  (19.2)
7.Primary Outcome
Title AUC of d-Amphetamine
Hide Description [Not Specified]
Time Frame Day 15 and Day 30 (24 hour sampling)
Hide Outcome Measure Data
Hide Analysis Population Description
PAS
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
Hide Arm/Group Description:
LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: ng*hr/ml
Day 15 1143.4  (292.8) 0  (0)
Day 30 1135.4  (301.5) 1049.2  (268.7)
8.Primary Outcome
Title AUC of Venlafaxine Hydrochloride
Hide Description [Not Specified]
Time Frame Day 15 and Day 30 (24 hour sampling)
Hide Outcome Measure Data
Hide Analysis Population Description
PAS
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
Hide Arm/Group Description:
LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: ng*hr/ml
Day 15 0  (0) 2900.0  (1919.3)
Day 30 2839.7  (1706.8) 3202.6  (1942.5)
9.Primary Outcome
Title AUC of o-Desmethylvenlafaxine
Hide Description [Not Specified]
Time Frame Day 15 and Day 30 (24 hour sampling)
Hide Outcome Measure Data
Hide Analysis Population Description
PAS
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
Hide Arm/Group Description:
LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: ng*hr/ml
Day 15 0  (0) 8363.3  (2168.1)
Day 30 8061.3  (2868.7) 6955.1  (1962.8)
10.Primary Outcome
Title AUC of Composite (Venlafaxine + o-Desmethylvenlafaxine)
Hide Description [Not Specified]
Time Frame Day 15 and Day 30 (24 hour sampling)
Hide Outcome Measure Data
Hide Analysis Population Description
PAS
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
Hide Arm/Group Description:
LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: ng*hr/ml
Day 15 0  (0) 10738.0  (3273.3)
Day 30 10673.9  (3035.7) 10342.2  (3096.1)
11.Primary Outcome
Title Time of Maximum Plasma Concentration (Tmax) of Lisdexamfetamine Dimesylate
Hide Description [Not Specified]
Time Frame Day 15 and Day 30 (24 hour sampling)
Hide Outcome Measure Data
Hide Analysis Population Description
PAS
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
Hide Arm/Group Description:
LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: hours
Day 15 1.1  (0.3) 0  (0)
Day 30 1.1  (0.3) 1.0  (0.3)
12.Primary Outcome
Title Tmax of d-Amphetamine
Hide Description [Not Specified]
Time Frame Day 15 and Day 30 (24 hour sampling)
Hide Outcome Measure Data
Hide Analysis Population Description
PAS
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
Hide Arm/Group Description:
LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: hours
Day 15 3.5  (1.5) 0  (0)
Day 30 3.2  (1.0) 3.1  (1.3)
13.Primary Outcome
Title Tmax of Venlafaxine Hydrochloride
Hide Description [Not Specified]
Time Frame Day 15 and Day 30 (24 hour sampling)
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PAS
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
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LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: hours
Day 15 0  (0) 6.4  (0.8)
Day 30 6.0  (1.3) 5.9  (0.6)
14.Primary Outcome
Title Tmax of o-Desmethylvenlafaxine
Hide Description [Not Specified]
Time Frame Day 15 and Day 30 (24 hour sampling)
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PAS
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
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LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: hours
Day 15 0  (0) 7.9  (1.2)
Day 30 8.5  (1.7) 7.9  (1.3)
15.Primary Outcome
Title Tmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)
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Time Frame Day 15 and Day 30 (24 hour sampling)
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PAS
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
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LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: hours
Day 15 0  (0) 7.3  (1.1)
Day 30 7.1  (1.4) 7.0  (1.2)
16.Secondary Outcome
Title Systolic Blood Pressure
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Time Frame Baseline and up to 39 days
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Safety Analysis Set (SAS) defined as all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
Hide Arm/Group Description:
LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 40 37
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 110.17  (8.996) 110.48  (9.623)
Up to 39 Days 117.82  (8.547) 121.51  (7.695)
17.Secondary Outcome
Title Diastolic Blood Pressure
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Time Frame Baseline and up to 39 days
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SAS
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
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LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 40 37
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 73.69  (7.446) 73.68  (6.730)
Up to 39 Days 77.85  (6.628) 80.45  (7.4515)
18.Secondary Outcome
Title Pulse Rate
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Time Frame Baseline and up to 39 days
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SAS
Arm/Group Title LDX + Venlafaxine XR Venlafaxine XR + LDX
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LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
Overall Number of Participants Analyzed 40 37
Mean (Standard Deviation)
Unit of Measure: bpm
Baseline 66.24  (7.940) 66.55  (10.318)
Up to 39 Days 77.47  (8.621) 81.72  (7.068)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LDX (SPD489) LDX + Venlafaxine XR/Venlafaxine XR + LDX Venlafaxine XR Titration Venlafaxine XR Tapering
Hide Arm/Group Description Titration dosing period Combination dosing periods Titration dosing period (Effexor XR 75, 150, and 225 mg) Tapering dosing period (Effexor XR 150 and 75 mg)
All-Cause Mortality
LDX (SPD489) LDX + Venlafaxine XR/Venlafaxine XR + LDX Venlafaxine XR Titration Venlafaxine XR Tapering
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LDX (SPD489) LDX + Venlafaxine XR/Venlafaxine XR + LDX Venlafaxine XR Titration Venlafaxine XR Tapering
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/40 (2.50%)      0/67 (0.00%)      0/37 (0.00%)      0/67 (0.00%)    
Nervous system disorders         
Presyncope  1/40 (2.50%)  1 0/67 (0.00%)  0 0/37 (0.00%)  0 0/67 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDX (SPD489) LDX + Venlafaxine XR/Venlafaxine XR + LDX Venlafaxine XR Titration Venlafaxine XR Tapering
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/40 (82.50%)      46/67 (68.66%)      25/37 (67.57%)      20/67 (29.85%)    
Cardiac disorders         
Palpitations  8/40 (20.00%)  11 2/67 (2.99%)  3 0/37 (0.00%)  0 0/67 (0.00%)  0
Eye disorders         
Vision Blurred  2/40 (5.00%)  2 0/67 (0.00%)  0 0/37 (0.00%)  0 0/67 (0.00%)  0
Gastrointestinal disorders         
Constipation  3/40 (7.50%)  3 11/67 (16.42%)  14 3/37 (8.11%)  3 0/67 (0.00%)  0
Diarrhea  2/40 (5.00%)  3 2/67 (2.99%)  2 3/37 (8.11%)  3 2/67 (2.99%)  2
Dry Mouth  10/40 (25.00%)  13 6/67 (8.96%)  6 7/37 (18.92%)  8 0/67 (0.00%)  0
Nausea  6/40 (15.00%)  7 4/67 (5.97%)  4 7/37 (18.92%)  9 6/67 (8.96%)  7
Stomach Discomfort  2/40 (5.00%)  2 0/67 (0.00%)  0 0/37 (0.00%)  0 0/67 (0.00%)  0
General disorders         
Chest Pain  3/40 (7.50%)  3 1/67 (1.49%)  1 0/37 (0.00%)  0 0/67 (0.00%)  0
Metabolism and nutrition disorders         
Anorexia  12/40 (30.00%)  21 0/67 (0.00%)  0 9/37 (24.32%)  10 0/67 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back Pain  2/40 (5.00%)  2 0/67 (0.00%)  0 0/37 (0.00%)  0 0/67 (0.00%)  0
Nervous system disorders         
Dizziness  3/40 (7.50%)  3 7/67 (10.45%)  9 4/37 (10.81%)  5 7/67 (10.45%)  7
Headache  7/40 (17.50%)  8 13/67 (19.40%)  17 6/37 (16.22%)  6 3/67 (4.48%)  3
Somnolence  7/40 (17.50%)  7 0/67 (0.00%)  0 7/37 (18.92%)  7 3/67 (4.48%)  3
Psychiatric disorders         
Anxiety  5/40 (12.50%)  7 2/67 (2.99%)  2 0/37 (0.00%)  0 0/67 (0.00%)  0
Euphoric Mood  3/40 (7.50%)  4 0/67 (0.00%)  0 0/37 (0.00%)  0 0/67 (0.00%)  0
Insomnia  7/40 (17.50%)  7 5/67 (7.46%)  6 3/37 (8.11%)  5 0/67 (0.00%)  0
Libido Decreased  0/40 (0.00%)  0 0/67 (0.00%)  0 2/37 (5.41%)  2 0/67 (0.00%)  0
Renal and urinary disorders         
Urinary Hesitation  0/40 (0.00%)  0 5/67 (7.46%)  5 0/37 (0.00%)  0 0/67 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnea  2/40 (5.00%)  2 1/67 (1.49%)  1 0/37 (0.00%)  0 0/67 (0.00%)  0
Epistaxis  0/40 (0.00%)  0 5/67 (7.46%)  5 0/37 (0.00%)  0 0/67 (0.00%)  0
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: Patrick Martin, MD
Organization: Shire Pharmaceutical
EMail: pmartin@shire.com
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01235338     History of Changes
Other Study ID Numbers: SPD489-117
First Submitted: November 2, 2010
First Posted: November 5, 2010
Results First Submitted: November 4, 2011
Results First Posted: December 8, 2011
Last Update Posted: April 4, 2013