Trial Outcomes & Findings for Aripiprazole Open-Label, Safety and Tolerability Study (NCT NCT00102518)
NCT ID: NCT00102518
Last Updated: 2012-08-31
Results Overview
Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
325 participants
Primary outcome timeframe
Baseline and Week 23
Results posted on
2012-08-31
Participant Flow
Participants were recruited from 157 centers in Argentina, Bulgaria, Croatia, India, Jamaica, Mexico, Romania, Russia, Serbia, South Africa, South Korea, Ukraine, and the United States between September 2004 and February 2007. A total of 325 subjects were screened for enrollment and all 325 subjects were enrolled.
All participants had previously completed NCT00102063 (OPDC 31-03-239, adolescents with schizophrenia) or had withdrawn from the double-blind extension phase of NCT00110461 (OPDC 31-03-240, children and adolescents with bipolar 1 disorder), both clinical studies of aripiprazole.
Participant milestones
| Measure |
NCT00102063 and NCT00110461 Subjects
All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
|
|---|---|
|
Overall Study
STARTED
|
325
|
|
Overall Study
COMPLETED
|
238
|
|
Overall Study
NOT COMPLETED
|
87
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aripiprazole Open-Label, Safety and Tolerability Study
Baseline characteristics by cohort
| Measure |
NCT00102063 and NCT00110461 Subjects
n=325 Participants
All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
|
|---|---|
|
Age Continuous
|
15.02 years
STANDARD_DEVIATION 1.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
185 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
281 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
206 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Height
|
164.09 cm
STANDARD_DEVIATION 11.22 • n=5 Participants
|
|
Weight
|
63.19 kg
STANDARD_DEVIATION 17.86 • n=5 Participants
|
|
Body Mass Index (BMI)
|
23.25 kg/m^2
STANDARD_DEVIATION 5.21 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 23Population: All enrolled subjects.
Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity.
Outcome measures
| Measure |
NCT00102063 and NCT00110461 Subjects
n=325 Participants
All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
|
|---|---|
|
Percentage of Subjects Experiencing SAEs
|
6.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26Change from baseline to the last scheduled post-baseline evaluation in PANSS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26). This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome.
Outcome measures
| Measure |
NCT00102063 and NCT00110461 Subjects
n=234 Participants
All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
|
|---|---|
|
Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score
|
-7.5 points
Standard Deviation 17.89
|
SECONDARY outcome
Timeframe: Baseline and Week 26Change from baseline to last scheduled post-baseline evaluation in YMRS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26). The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).
Outcome measures
| Measure |
NCT00102063 and NCT00110461 Subjects
n=82 Participants
All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
|
|---|---|
|
Change in Young Mania Rating Scale (Y-MRS) Total Score
|
-7.74 points
Standard Deviation 11.73
|
Adverse Events
NCT00102063 and NCT00110461 Subjects
Serious events: 20 serious events
Other events: 230 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NCT00102063 and NCT00110461 Subjects
n=325 participants at risk
All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
|
|---|---|
|
Infections and infestations
Bronchitis acute
|
0.31%
1/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Infections and infestations
Hepatitis A
|
0.31%
1/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Injury, poisoning and procedural complications
Electrocution
|
0.31%
1/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.31%
1/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Psychiatric disorders
Acute psychosis
|
0.31%
1/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Psychiatric disorders
Aggression
|
0.92%
3/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Psychiatric disorders
Bipolar disorder
|
0.92%
3/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Psychiatric disorders
Depression
|
0.31%
1/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Psychiatric disorders
Hallucination, auditory
|
0.31%
1/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Psychiatric disorders
Homicidal ideation
|
0.31%
1/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Psychiatric disorders
Impulsive behavior
|
0.31%
1/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Psychiatric disorders
Intentional self injury
|
0.31%
1/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Psychiatric disorders
Psychotic disorder
|
0.62%
2/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Psychiatric disorders
Schizophrenia
|
1.2%
4/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Psychiatric disorders
Suicidal ideation
|
0.31%
1/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
Other adverse events
| Measure |
NCT00102063 and NCT00110461 Subjects
n=325 participants at risk
All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
7.7%
25/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Gastrointestinal disorders
Vomiting
|
5.5%
18/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
18/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Investigations
Weight increased
|
7.7%
25/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Metabolism and nutrition disorders
Increased appetite
|
4.6%
15/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Nervous system disorders
Akathisia
|
8.3%
27/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Nervous system disorders
Extrapyramidal disorder
|
14.8%
48/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Nervous system disorders
Headache
|
9.5%
31/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Nervous system disorders
Somnolence
|
12.9%
42/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Nervous system disorders
Tremor
|
5.8%
19/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
|
Psychiatric disorders
Insomnia
|
8.0%
26/325 • Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
|
Additional Information
Margaretta Nyilas
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: 609-452-5673
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place