Trial Outcomes & Findings for Cardiovascular Study of Lisdexamfetamine in Healthy and Hypertensive Attention Deficit Hyperactivity Disorder Adults (NCT NCT00753012)
NCT ID: NCT00753012
Last Updated: 2012-09-24
Results Overview
Size of the heart's left ventricle chamber (Left Ventricular End Diastolic Dimension; LVEDD) following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
3-6 months
Results posted on
2012-09-24
Participant Flow
Participant milestones
| Measure |
Normotensive Adults With ADHD
Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
|
Primary Hypertensive Adults With ADHD
Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of \<135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
9
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
Reasons for withdrawal
| Measure |
Normotensive Adults With ADHD
Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
|
Primary Hypertensive Adults With ADHD
Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of \<135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
|
|---|---|---|
|
Overall Study
Ineligible, abnormal cardiac histo
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Confounded endpoint data
|
1
|
0
|
Baseline Characteristics
Cardiovascular Study of Lisdexamfetamine in Healthy and Hypertensive Attention Deficit Hyperactivity Disorder Adults
Baseline characteristics by cohort
| Measure |
Normotensive Adults With ADHD
n=15 Participants
Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
|
Primary Hypertensive Adults With ADHD
n=9 Participants
Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of \<135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
34.80 years
STANDARD_DEVIATION 11.59 • n=5 Participants
|
51.33 years
STANDARD_DEVIATION 7.87 • n=7 Participants
|
41.00 years
STANDARD_DEVIATION 13.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
9 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3-6 monthsPopulation: 14 subjects completed endpoint TTE; one HTN subject missed the scheduled endpoint TTE appointment.
Size of the heart's left ventricle chamber (Left Ventricular End Diastolic Dimension; LVEDD) following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE)
Outcome measures
| Measure |
Normotensive Adults With ADHD
n=7 Participants
|
Primary Hypertensive Adults With ADHD
n=7 Participants
Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of \<135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
|
|---|---|---|
|
Left Ventricle Size
|
44.42 mm
Standard Deviation 7.07
|
43.57 mm
Standard Deviation 6.13
|
PRIMARY outcome
Timeframe: 3-6 monthsLeft ventricle diastolic function index, following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE)
Outcome measures
| Measure |
Normotensive Adults With ADHD
n=7 Participants
|
Primary Hypertensive Adults With ADHD
n=7 Participants
Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of \<135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
|
|---|---|---|
|
Cardiac Function Index (E/A Ratio)
|
1.38 cm/sec/cm/sec
Standard Deviation 0.48
|
1.36 cm/sec/cm/sec
Standard Deviation 0.84
|
PRIMARY outcome
Timeframe: 3-6 monthsDiastolic blood pressure (DBP) at maximum exertion following 3-6 months of stimulant medication, according to cardiopulmonary exercise testing (CPET)
Outcome measures
| Measure |
Normotensive Adults With ADHD
n=7 Participants
|
Primary Hypertensive Adults With ADHD
n=8 Participants
Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of \<135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
|
|---|---|---|
|
Blood Pressure at Maximum Exertion
|
80.43 mmHg
Standard Deviation 11.97
|
85.00 mmHg
Standard Deviation 8.07
|
Adverse Events
Normotensive Adults With ADHD
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Primary Hypertensive Adults With ADHD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Normotensive Adults With ADHD
n=14 participants at risk
Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
|
Primary Hypertensive Adults With ADHD
n=8 participants at risk
Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of \<135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
|
|---|---|---|
|
Psychiatric disorders
anxiety
|
14.3%
2/14 • Number of events 23
|
37.5%
3/8 • Number of events 39
|
|
General disorders
back pain
|
14.3%
2/14 • Number of events 7
|
0.00%
0/8
|
|
Eye disorders
blind spot
|
0.00%
0/14
|
12.5%
1/8 • Number of events 14
|
|
Eye disorders
blurred vision
|
7.1%
1/14 • Number of events 3
|
0.00%
0/8
|
|
General disorders
cold symptoms
|
35.7%
5/14 • Number of events 18
|
12.5%
1/8 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
congestion
|
28.6%
4/14 • Number of events 12
|
12.5%
1/8 • Number of events 16
|
|
Gastrointestinal disorders
constipation
|
7.1%
1/14 • Number of events 23
|
12.5%
1/8 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/14
|
12.5%
1/8 • Number of events 6
|
|
Psychiatric disorders
depressed mood
|
7.1%
1/14 • Number of events 1
|
12.5%
1/8 • Number of events 30
|
|
Reproductive system and breast disorders
difficulty achieving erection
|
7.1%
1/14 • Number of events 43
|
0.00%
0/8
|
|
General disorders
dry mouth
|
42.9%
6/14 • Number of events 78
|
50.0%
4/8 • Number of events 164
|
|
Skin and subcutaneous tissue disorders
dry skin
|
0.00%
0/14
|
12.5%
1/8 • Number of events 7
|
|
Psychiatric disorders
feelings of self-consciousness
|
7.1%
1/14 • Number of events 7
|
0.00%
0/8
|
|
General disorders
fever
|
0.00%
0/14
|
12.5%
1/8 • Number of events 12
|
|
Psychiatric disorders
feeling flustered
|
0.00%
0/14
|
12.5%
1/8 • Number of events 7
|
|
General disorders
foot pain
|
0.00%
0/14
|
12.5%
1/8 • Number of events 11
|
|
Gastrointestinal disorders
GI upset
|
7.1%
1/14 • Number of events 1
|
0.00%
0/8
|
|
General disorders
hand tremor
|
7.1%
1/14 • Number of events 3
|
0.00%
0/8
|
|
General disorders
headache
|
57.1%
8/14 • Number of events 22
|
25.0%
2/8 • Number of events 6
|
|
General disorders
heartburn
|
7.1%
1/14 • Number of events 3
|
25.0%
2/8 • Number of events 6
|
|
General disorders
increased energy
|
7.1%
1/14 • Number of events 5
|
25.0%
2/8 • Number of events 60
|
|
General disorders
insomnia
|
21.4%
3/14 • Number of events 8
|
75.0%
6/8 • Number of events 19
|
|
Psychiatric disorders
irritability
|
14.3%
2/14 • Number of events 11
|
12.5%
1/8 • Number of events 1
|
|
General disorders
jaw tension
|
14.3%
2/14 • Number of events 18
|
25.0%
2/8 • Number of events 132
|
|
General disorders
jittery
|
35.7%
5/14 • Number of events 27
|
12.5%
1/8 • Number of events 14
|
|
General disorders
lightheadedness
|
7.1%
1/14 • Number of events 2
|
12.5%
1/8 • Number of events 2
|
|
General disorders
lip swelling
|
0.00%
0/14
|
12.5%
1/8 • Number of events 2
|
|
Metabolism and nutrition disorders
low appetite
|
35.7%
5/14 • Number of events 111
|
12.5%
1/8 • Number of events 2
|
|
General disorders
low energy
|
14.3%
2/14 • Number of events 5
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
muscle aches
|
21.4%
3/14 • Number of events 70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
muscle tension
|
14.3%
2/14 • Number of events 21
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
muscle twitch
|
14.3%
2/14 • Number of events 7
|
0.00%
0/8
|
|
General disorders
nausea
|
0.00%
0/14
|
37.5%
3/8 • Number of events 11
|
|
General disorders
numbness
|
0.00%
0/14
|
12.5%
1/8 • Number of events 1
|
|
General disorders
racing
|
7.1%
1/14 • Number of events 14
|
25.0%
2/8 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
sinus pain
|
0.00%
0/14
|
12.5%
1/8 • Number of events 7
|
|
General disorders
tension
|
0.00%
0/14
|
12.5%
1/8 • Number of events 3
|
|
General disorders
tightness in the hand
|
7.1%
1/14 • Number of events 1
|
0.00%
0/8
|
|
Renal and urinary disorders
urinary tract infection
|
7.1%
1/14 • Number of events 2
|
0.00%
0/8
|
|
Infections and infestations
viral illness
|
7.1%
1/14 • Number of events 14
|
0.00%
0/8
|
|
Gastrointestinal disorders
vomiting
|
14.3%
2/14 • Number of events 4
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place