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Trial record 13 of 28 for:    Developmental Disabilities | ( Map: Minnesota, United States )

Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)

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ClinicalTrials.gov Identifier: NCT00365859
Recruitment Status : Completed
First Posted : August 18, 2006
Results First Posted : January 25, 2010
Last Update Posted : December 2, 2013
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Autistic Disorder
Behavioral Symptoms
Intervention Drug: Aripiprazole
Enrollment 330
Recruitment Details  
Pre-assignment Details 109 participants were enrolled in the De Novo arm, 70 in the Rollover Placebo arm, and 174 in the Rollover Aripiprazole arm. 23 participants in the De Novo arm were considered "baseline failures," and did not enter the treatment phase.
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
Hide Arm/Group Description De novo participants (those who did not participate in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) assigned to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose. Participants who completed participation in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) on placebo treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose. Participants who completed participation in protocol CN138-178 [NCT00332241] or CN138-179 [NCT00337571] on aripiprazole treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose. Total of all reporting groups
Period Title: Overall Study
Started 86 70 174 330
Safety Population 86 70 174 330
Efficacy Population 84 [1] 69 [2] 169 [3] 322
Completed 55 37 107 199
Not Completed 31 33 67 131
[1]
1 patient was lost to follow-up and 1 not included due to moderate sedation (total=2)
[2]
1 not included due to increased alanine aminotransferase (ALT) prior to treatment with aripiprazole
[3]
3 lost to follow-up, 1 not included due to mild increased appetite, 1 to family emergency (total=5)
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
Hide Arm/Group Description As previously described in Participant Flow As previously described in Participant Flow As previously described in Participant Flow Total of all reporting groups
Overall Number of Baseline Participants 86 70 174 330
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 70 participants 174 participants 330 participants
6 to 12 years 69 56 138 263
13 to 17 years 17 14 36 67
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 70 participants 174 participants 330 participants
9.7  (3.13) 9.6  (2.95) 9.5  (3.00) 9.6  (3.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 70 participants 174 participants 330 participants
Female
16
  18.6%
8
  11.4%
19
  10.9%
43
  13.0%
Male
70
  81.4%
62
  88.6%
155
  89.1%
287
  87.0%
1.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs
Hide Description Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time Frame From Screening (up to 42 days prior to treatment start) through Week 52 (end of study) for SAEs; from Week 0 (Baseline) through Week 52 (End of Study) for AEs
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Safety Population
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
Hide Arm/Group Description:
As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 86 70 174 330
Measure Type: Number
Unit of Measure: Participants
Deaths 0 0 0 0
Treatment-Emergent SAEs 3 1 5 9
Treatment-Emergent AEs 75 63 148 286
Treatment-Emergent AEs Leading to Discontinuation 9 10 14 33
Treatment-Emergent EPS-Related AEs 16 6 26 48
2.Primary Outcome
Title Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52
Hide Description The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement.
Time Frame Baseline, Week 8, Week 26, Week 52
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Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
Hide Arm/Group Description:
As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 86 70 174 330
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=79, 63, 153, 295) 10.7  (1.40) 10.6  (1.17) 11.0  (2.11) 10.8  (1.77)
Change at Week 8 (n=77, 60, 145, 282) -0.3  (1.13) 0.1  (1.51) -0.4  (2.12) -0.2  (1.78)
Change at Week 26 (n=61, 47, 126, 234) -0.2  (1.59) 0.2  (1.42) -0.6  (1.96) -0.3  (1.79)
Change at Week 52 (n=48, 36, 91, 175) -0.6  (1.44) 0.3  (1.80) -0.5  (1.82) -0.3  (1.75)
Change at Endpoint (LOCF) (n=79, 63, 153, 295) -0.2  (1.70) 0.3  (1.59) -0.3  (2.06) -0.1  (1.89)
3.Primary Outcome
Title Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52
Hide Description The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.
Time Frame Baseline, Week 8, Week 26, Week 52
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Hide Analysis Population Description
Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
Hide Arm/Group Description:
As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 86 70 174 330
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=79, 67, 155, 301) 0.5  (1.90) 0.5  (1.02) 0.3  (1.23) 0.4  (1.40)
Change at Week 8 (n=78, 64, 149, 291) -0.3  (1.45) -0.1  (0.87) -0.1  (1.15) -0.2  (1.18)
Change at Week 26 (n=61, 49, 130, 240) -0.4  (1.37) -0.0  (1.30) -0.2  (1.26) -0.2  (1.30)
Change at Week 52 (n=48, 36, 93, 177) -0.4  (1.44) -0.0  (1.00) -0.1  (1.13) -0.2  (1.20)
Change at Endpoint (LOCF) (n=79, 67, 155, 301) -0.3  (1.33) 0.0  (1.44) -0.1  (1.32) -0.1  (1.35)
4.Primary Outcome
Title Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint
Hide Description The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.
Time Frame Baseline, Week 8, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
Hide Arm/Group Description:
As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 86 70 174 330
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=79, 64, 154, 297) 0.1  (0.57) 0.2  (0.54) 0.1  (0.41) 0.1  (0.49)
Change at Week 8 (n=78, 60, 149, 287) -0.1  (0.55) -0.1  (0.50) 0.0  (0.35) 0.0  (0.44)
Change at Week 26 (n=61, 47, 129, 237) -0.1  (0.64) -0.1  (0.48) 0.0  (0.41) 0.0  (0.50)
Change at Week 52 (n=48, 35, 93, 176) -0.1  (0.37) 0.0  (0.49) 0.1  (0.56) 0.0  (0.50)
Change at Endpoint (LOCF) (n=79, 64, 154, 297) 0.0  (0.67) 0.0  (0.52) 0.1  (0.58) 0.0  (0.59)
5.Primary Outcome
Title Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities
Hide Description Abnormal metabolic criterion values include the following: fasting serum glucose ≥115 mg/dL; non-fasting serum glucose ≥ 200 mg/dL; total cholesterol ≥240 mg/dL; LDL cholesterol ≥160 mg/dL; HDL cholesterol ≤30 mg/dL; triglycerides ≥120 mg/dL (females), ≥160 mg/dL (males)
Time Frame At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52
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Safety Sample
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
Hide Arm/Group Description:
As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 86 70 174 330
Measure Type: Number
Unit of Measure: Participants
Glucose, Fasting Serum 1 1 5 7
Glucose, Serum 0 0 0 0
Cholesterol, HDL Fasting 4 3 7 14
Cholesterol, HDL Non-Fasting 4 3 10 17
Cholesterol, HDL Random 7 6 16 29
Cholesterol, LDL Fasting 0 0 2 2
Cholesterol, LDL Non-Fasting 0 0 0 0
Cholesterol, LDL Random 0 0 2 2
Cholesterol, Total Fasting 1 0 1 2
Cholesterol, Total Non-Fasting 0 0 1 1
Cholesterol, Total Random 1 0 2 3
Triglycerides, Fasting 10 8 20 38
Triglycerides, Non-Fasting 15 12 33 60
Triglycerides, Random 22 20 47 89
6.Primary Outcome
Title Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities
Hide Description Abnormal hematology criterion values include the following: hematocrit (ages 6-17, males & females) ≤33%; hemoglobin (ages 6-17, males & females) <11.3 g/dL; leukocytes ≤2800 c/mm3 or ≥16000 c/mm3; eosinophils (ages 6-17, males & females) >17%; neutrophils <15%; platelet count ≤75,000 c/mm3 or ≥700,000 c/mm3
Time Frame At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
Hide Arm/Group Description:
As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 86 70 174 330
Measure Type: Number
Unit of Measure: Participants
Hematocrit 0 0 2 2
Hemoglobin 0 2 3 5
Leukocytes 2 0 3 5
Platelet Count 0 1 0 1
Eosinophils, relative 0 1 3 4
Neutrophils, relative 1 0 0 1
7.Primary Outcome
Title Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities
Hide Description Abnormal chemistry criterion values include the following: aspartate aminotransferase ≥3x upper limit of normal (ULN); alanine aminotransferase ≥3x ULN; alkaline phosphatase ≥3x ULN; lactate dehydrogenase ≥3x ULN; creatinine ≥2.0 mg/dL; uric acid, ≥10.5 mg/dL (male), ≥8.5 mg/dL (female); bilirubin (Total) ≥2.0 mg/dL; serum prolactin >ULN; creatine kinase ≥3x ULN; blood urea nitrogen ≥30 mg/dL; sodium ≤126 mEq/L or ≥156 mEq/L; potassium ≤2.5 mEq/L or ≥ 6.5 mEq/L; chloride ≤90 mEq/L or ≥118 mEq/L; calcium ≤8.2 mg/dL or ≥12 mg/dL
Time Frame At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
Hide Arm/Group Description:
As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 86 70 174 330
Measure Type: Number
Unit of Measure: Participants
Alanine Aminotransferase 3 2 5 10
Aspartate Aminotransferase 0 0 2 2
Alkaline Phosphatase 0 0 0 0
Prolactin 2 0 0 2
Lactate Dehydrogenase 0 0 0 0
Creatinine 0 0 0 0
Uric Acid 0 0 0 0
Bilirubin, Total 0 0 0 0
Creatine Kinase 2 4 7 13
Blood Urea Nitrogen 0 1 1 2
Sodium, Serum 0 0 0 0
Potassium, Serum 0 0 0 0
Chloride, Serum 0 0 0 0
Calcium, Total 0 0 0 0
8.Primary Outcome
Title Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities
Hide Description These abbreviations are used in the table of ECG measurements: supraventricular (SV), baseline (BL), 1 degree (1°), atrioventricular (A-V), intraventricular (IVT), symmetrical (SYM), corrected QT interval (QTc). QRS complex is a recording of a single heartbeat on ECG corresponding to the depolarization of the right and left ventricles. PR interval is measured from beginning of P wave to beginning of QRS complex. QT interval is a measure of time between start of Q wave and end of T wave in the heart's electrical cycle. ↑ = increase from baseline, ↓ = decrease from baseline, → = "to"
Time Frame At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
Hide Arm/Group Description:
As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 86 70 174 330
Measure Type: Number
Unit of Measure: Participants
Sinus Tachycardia (≥140 bpm & ↑ ≥15 bpm) 2 0 2 4
Sinus Bradycardia (≤50 bpm and ↓ ≥15 bpm) 0 0 0 0
SV Premature Beat (≥2per10sec & ↑ over BL) 0 0 0 0
Ventricular Premature Beat(≥1per10sec & ↑ over BL) 0 0 0 0
SV Tachycardia (not present → present) 0 0 0 0
Ventricular Tachycardia (not present → present) 0 0 0 0
Atrial Fibrillation (not present → present) 0 0 0 0
Atrial Flutter (not present → present) 0 0 0 0
1° A-V Block (PR ≥ 0.20 sec and ↑ ≥ 0.05 sec) 0 0 1 1
2° A-V block (not present → present) 0 0 0 0
3° A-V block (not present → present) 0 0 0 0
Left Bundle Branch Block (not present → present) 0 0 0 0
Right Bundle Branch Block (not present → present) 0 0 0 0
Pre-Excitation Syndrome (not present → present) 0 0 0 0
Other ITV Block (QRS ≥ 0.10 sec & ↑ 0.02 sec) 0 0 3 3
Old Infarction (not present-present at ≥12 weeks) 0 0 0 0
Acute/Subacute Infarction (not present → present) 0 0 0 0
Myocardial Ischemia (not present → present) 0 0 0 0
SYM T-Wave Inversion (not present → present) 0 0 0 0
QTcB interval (>475 msec & elevation 10% over BL) 1 0 2 3
QTcF interval (>475 msec & elevation 10% over BL) 1 0 0 1
Other Abnormality 3 3 6 12
9.Primary Outcome
Title Number of Potentially Clinically Relevant Vital Sign Abnormalities
Hide Description Clinically significantly abnormal vital signs met age-appropriate (heart rate cohorts: ages 5-14 & ages 15+; blood pressure cohorts: ages 6-12 & ages 13-17) criterion AND represented change from pretreatment value of at least the following magnitudes: systolic blood pressure (≥130 mmHg & ≥144 mmHg w/ increase of ≥20 mmHg) or (≤117 mmHg & ≤120 mmHg w/ decrease of ≥20 mmHg); diastolic blood pressure (≥86 mmHg & ≥92 mmHg w/ increase of ≥15 mmHg) or (≤75 mm Hg & ≤80 mmHg w/ decrease of ≥15 mmHg); heart rate (140 bpm and 120 bpm w/ increase of ≥15 bpm) or (50 bpm and 50 bpm w/ decrease of ≥15 bpm).
Time Frame At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)
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Safety Sample
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
Hide Arm/Group Description:
As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 86 70 174 330
Measure Type: Number
Unit of Measure: Participants
Supine Systolic Blood Pressure Increase 5 2 18 25
Supine Systolic Blood Pressure Decrease 14 15 27 56
Standing Systolic Blood Pressure Increase 6 7 13 26
Standing Systolic Blood Pressure Decrease 16 22 25 63
Sitting Systolic Blood Pressure Increase 3 1 6 10
Sitting Systolic Blood Pressure Decrease 11 8 13 32
Supine Diastolic Blood Pressure Increase 6 5 11 22
Supine Diastolic Blood Pressure Decrease 15 19 38 72
Standing Diastolic Blood Pressure Increase 3 8 17 28
Standing Diastolic Blood Pressure Decrease 22 20 36 78
Sitting Diastolic Blood Pressure Increase 2 2 1 5
Sitting Diastolic Blood Pressure Decrease 14 8 9 31
Supine Heart Rate Increase 1 1 2 4
Supine Heart Rate Decrease 0 0 0 0
Standing Heart Rate Increase 5 3 4 12
Standing Heart Rate Decrease 0 0 1 1
Sitting Heart Rate Increase 1 0 1 2
Sitting Heart Rate Decrease 0 0 0 0
10.Primary Outcome
Title Mean Change From Baseline in Patient Weight
Hide Description [Not Specified]
Time Frame At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
Hide Arm/Group Description:
As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 86 70 174 330
Mean (Standard Deviation)
Unit of Measure: kg
Baseline (n=84, 69, 169, 322) 42.5  (23.17) 45.1  (20.37) 45.4  (21.79) 44.6  (21.83)
Change at Week 1 (n=78, 58, 149, 285) 0.2  (0.76) -0.1  (1.06) 0.4  (0.94) 0.3  (0.94)
Change at Week 2 (n=81, 67, 165, 313) 0.2  (0.99) 0.0  (1.47) 0.8  (1.15) 0.5  (1.23)
Change at Week 4 (n=80, 67, 165, 312) 0.8  (1.26) 0.5  (1.60) 1.2  (1.43) 1.0  (1.45)
Change at Week 8 (n=77, 65, 149, 291) 1.6  (1.99) 1.5  (2.29) 1.9  (2.09) 1.8  (2.11)
Change at Week 14 (n=71, 55, 142, 268) 3.3  (2.81) 2.8  (2.79) 3.1  (2.80) 3.1  (2.80)
Change at Week 20 (n=66, 50, 136, 252) 4.0  (3.39) 3.3  (4.73) 4.2  (3.34) 4.0  (3.67)
Change at Week 26 (n=61, 49, 130, 240) 5.0  (4.41) 4.7  (4.36) 4.9  (3.99) 4.9  (4.16)
Change at Week 34 (n=60, 46, 123, 229) 6.0  (5.80) 5.8  (4.90) 6.1  (4.68) 6.0  (5.02)
Change at Week 42 (n=58, 43, 115, 216) 7.0  (6.46) 6.4  (5.90) 7.1  (5.11) 6.9  (5.64)
Change at Week 52 (n=48, 36, 94, 178) 8.7  (6.77) 7.7  (6.44) 7.9  (5.90) 8.1  (6.23)
Change at Endpoint (LOCF) (n=84, 69, 169, 322) 6.3  (6.71) 5.5  (5.50) 6.6  (5.72) 6.3  (5.94)
11.Primary Outcome
Title Mean Change From Baseline by Time Period in Body Weight Z-Score
Hide Description The Z-Score indicates how many standard deviations a person is from the population norm values. The body weight z-scores are designed to take into account the amount of weight gain that would be expected due to normal growth in children and adolescents. The body weight z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual weight measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record).
Time Frame At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)
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Hide Analysis Population Description
Safety Sample. Subjects included in the period evaluation had a baseline and at least 1 measurement within the time period that was assessed. Patients are only counted once in each time period but can appear in multiple time periods. For those with multiple records in 1 time period, only the last record in that period is included in calculations.
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
Hide Arm/Group Description:
As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 86 70 174 330
Mean (Standard Deviation)
Unit of Measure: Standard Deviations away from Population
Baseline (n=84, 70, 169, 323) 0.47  (1.687) 0.95  (1.112) 0.98  (1.392) 0.84  (1.434)
<= 3 Months (n=84, 70, 169, 323) 0.13  (0.283) 0.10  (0.204) 0.09  (0.300) 0.10  (0.277)
3-6 Months (n=73, 56, 145, 274) 0.24  (0.433) 0.26  (0.331) 0.20  (0.327) 0.22  (0.359)
6-9 Months (n=63, 49, 131, 243) 0.31  (0.570) 0.28  (0.367) 0.23  (0.407) 0.26  (0.448)
>9 Months (n=59, 44, 115, 218) 0.33  (0.580) 0.23  (0.399) 0.24  (0.465) 0.26  (0.486)
12.Primary Outcome
Title Mean Change From Baseline in Patient Body Mass Index (BMI)
Hide Description The body mass index (BMI) is a statistical measurement which compares a person's weight and height. Though it does not actually measure the percentage of body fat, it is used to estimate a healthy body weight based on subject height.
Time Frame At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)
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Safety Sample: Endpoint - Last Observation Carried Forward (LOCF)
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
Hide Arm/Group Description:
As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 86 70 174 330
Mean (Standard Deviation)
Unit of Measure: kg/m2
Baseline (n=84, 69, 169, 322) 20.1  (6.31) 21.0  (5.15) 21.6  (6.38) 21.1  (6.13)
Change at Endpoint (LOCF) (n=84, 69, 169, 322) 1.7  (2.56) 1.4  (2.07) 1.8  (2.51) 1.7  (2.43)
13.Primary Outcome
Title Mean Change From Baseline By Time Period in BMI Z-Score
Hide Description The Z-Score indicates how many standard deviations a person is from the population norm values. The BMI z-scores are designed to take into account the BMI that would be expected due to normal growth in children and adolescents. The BMI z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual BMI measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record).
Time Frame At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)
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Safety Sample. Subjects included in the period evaluation had a baseline and at least 1 measurement within the time period that was assessed. Patients are only counted once in each time period but can appear in multiple time periods. For those with multiple records in 1 time period, only the last record in that period is included in calculations.
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
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As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 86 70 174 330
Mean (Standard Deviation)
Unit of Measure: Standard Deviations away from Population
Baseline (n=84, 70, 169, 323) 0.44  (1.591) 0.98  (0.997) 1.01  (1.236) 0.86  (1.313)
<=3 Months (n=84, 70, 169, 323) 0.17  (0.436) 0.12  (0.268) 0.09  (0.500) 0.12  (0.443)
3-6 Months (n=73, 56, 145, 274) 0.29  (0.625) 0.28  (0.388) 0.18  (0.549) 0.23  (0.543)
6-9 Months (n=62, 49, 129, 240) 0.36  (0.647) 0.24  (0.438) 0.18  (0.643) 0.24  (0.611)
>9 Months (n=59, 44, 115, 218) 0.33  (0.768) 0.15  (0.476) 0.14  (0.775) 0.19  (0.725)
14.Secondary Outcome
Title Mean Change From Baseline in Clinical Global Impression (CGI)-Severity Score at Week 52 (Endpoint, LOCF)
Hide Description CGI scale is a global evaluation of improvement over time. CGI-Severity (CGI-S) is a clinician-rated assessment that evaluates the severity of a patient's condition on a 7-point scale ranging from 1 (no symptoms) to 7 (very severe symptoms). CGI-Severity score is from 1 to 7. A negative change score signifies improvement.
Time Frame Week 0 (Baseline), Week 52 (Endpoint, LOCF)
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Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations.
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As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 84 69 169 322
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 4.8  (0.99) 4.2  (0.99) 3.9  (1.05) 4.2  (1.08)
Change at Endpoint (LOCF) -0.8  (0.85) -0.4  (1.06) -0.0  (1.01) -0.3  (1.04)
15.Secondary Outcome
Title CGI-Improvement Score at Week 52 (Endpoint, LOCF)
Hide Description CGI scale is a global evaluation of improvement over time. CGI-Improvement (CGI-I) is a clinician rated assessment that evaluates improvement relative to symptoms at baseline on a a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). CGI-I Score is from 1 to 7. A lower score signifies larger improvement.
Time Frame Week 52 (Endpoint, LOCF)
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Efficacy Sample. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations.
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
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As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 84 69 169 322
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.7  (1.30) 2.4  (1.24) 2.5  (1.20) 2.5  (1.23)
16.Secondary Outcome
Title Mean Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Score at Week 52 (Endpoint, LOCF)
Hide Description The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Irritability Subscale Score is from 0 to 45. A negative change signifies improvement
Time Frame Week 0 (Baseline), Week 52 (Endpoint, LOCF)
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Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
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As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 80 68 166 314
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 23.2  (8.88) 21.5  (9.82) 15.0  (9.20) 18.5  (9.96)
Change at Endpoint (LOCF) -6.5  (11.12) -6.1  (11.25) 0.7  (9.72) -2.6  (10.98)
17.Secondary Outcome
Title Mean Change From Baseline in ABC Hyperactivity Subscale Score at Week 52 (Endpoint, LOCF)
Hide Description The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Hyperactivity Subscale Score is from 0 to 48. A negative change score signifies improvement.
Time Frame Week 0 (Baseline), Week 52 (Endpoint, LOCF)
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Efficacy Sample, LOCF.The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
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As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 80 68 166 314
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 28.4  (10.87) 25.8  (13.18) 18.4  (12.03) 22.5  (12.79)
Change at Endpoint (LOCF) -10.0  (10.55) -8.3  (10.85) 0.3  (11.18) -4.2  (11.92)
18.Secondary Outcome
Title Change From Baseline in ABC Stereotypy Subscale Score at Week 52 (Endpoint, LOCF)
Hide Description The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Stereotypy Subscale Score is from 0 to 21. A negative change score signifies improvement.
Time Frame Week 0 (Baseline), Week 52 (Endpoint, LOCF)
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Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
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As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 80 68 166 314
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 8.1  (5.18) 8.1  (5.57) 6.4  (5.46) 7.2  (5.46)
Change at Endpoint (LOCF) -2.5  (4.67) -1.9  (4.46) 0.1  (4.58) -1.0  (4.71)
19.Secondary Outcome
Title Mean Change From Baseline in ABC Social Withdrawal Scale At Week 52 (Endpoint, LOCF)
Hide Description The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Social Withdrawal Subscale Score is from 0 to 48. A negative change score signifies improvement.
Time Frame Week 0 (Baseline), Week 52 (Endpoint, LOCF)
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Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
Hide Arm/Group Description:
As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 80 68 166 314
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 14.6  (8.62) 11.3  (9.24) 10.4  (8.86) 11.7  (9.03)
Change at Endpoint (LOCF) -5.4  (9.07) -3.0  (6.96) -1.8  (6.09) -3.0  (7.28)
20.Secondary Outcome
Title Mean Change From Baseline in ABC Inappropriate Speech Subscale Score at Week 52 (Endpoint, LOCF)
Hide Description The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Inappropriate Speech Subscale score is from 1 to 12. A negative change score signifies improvement.
Time Frame Week 0 (Baseline), Week 52 (Endpoint, LOCF)
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Efficacy Sample, LOCF
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
Hide Arm/Group Description:
As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 86 70 174 330
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 5.8  (3.15) 5.7  (4.23) 4.2  (3.61) 4.9  (3.72)
Change at Endpoint (LOCF) -1.9  (2.66) -1.8  (2.94) -0.3  (2.50) -1.0  (2.75)
21.Secondary Outcome
Title Change From Baseline in Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Score at Week 52 (Endpoint, LOCF)
Hide Description CY-BOCS is a 10-item, clinician-rated scale designed to measure the severity of obsessive-compulsive symptoms in patients below the age of 18. The scale contains 5 items pertaining to obsessions (which were not used in this trial) and 5 items pertaining to compulsions, which rated each symptom domain in terms of time spent, interference with functioning, distress, resistance, and control. Each item was rated on a 5-point scale, from 0 (no symptoms or minimum severity) to 4 (extreme symptoms or maximum severity). CY-BOCS Score is from 0 to 20. A negative change score signifies improvement.
Time Frame Week 0 (Baseline), Week 52 (Endpoint, LOCF)
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Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 96 patients did not have post-baseline evaluations for CY-BOCS, and were excluded from the efficacy analyses.
Arm/Group Title De Novo Rollover Placebo Rollover Aripiprazole Total
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As previously described in Participant Flow
As previously described in Participant Flow
As previously described in Participant Flow
Total of all reporting groups
Overall Number of Participants Analyzed 62 49 115 226
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 12.6  (4.60) 12.1  (3.96) 10.4  (3.87) 11.4  (4.20)
Change at Endpoint (LOCF) -2.0  (3.68) -2.4  (5.06) 0.2  (3.81) -0.9  (4.23)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
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All-Cause Mortality
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Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
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Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/86 (3.49%)   5/174 (2.87%)   1/70 (1.43%) 
Gastrointestinal disorders       
DYSPHAGIA  1  0/86 (0.00%)  1/174 (0.57%)  0/70 (0.00%) 
Hepatobiliary disorders       
CHOLECYSTITIS  1  0/86 (0.00%)  1/174 (0.57%)  0/70 (0.00%) 
CHOLELITHIASIS  1  0/86 (0.00%)  1/174 (0.57%)  0/70 (0.00%) 
Infections and infestations       
SINUSITIS  1  0/86 (0.00%)  1/174 (0.57%)  0/70 (0.00%) 
SKIN INFECTION  1  1/86 (1.16%)  0/174 (0.00%)  0/70 (0.00%) 
OTITIS MEDIA ACUTE  1  0/86 (0.00%)  1/174 (0.57%)  0/70 (0.00%) 
PHARYNGOTONSILLITIS  1  0/86 (0.00%)  1/174 (0.57%)  0/70 (0.00%) 
Nervous system disorders       
CONVULSION  1  0/86 (0.00%)  0/174 (0.00%)  1/70 (1.43%) 
Psychiatric disorders       
AGGRESSION  1  1/86 (1.16%)  1/174 (0.57%)  0/70 (0.00%) 
SUICIDAL IDEATION  1  1/86 (1.16%)  0/174 (0.00%)  0/70 (0.00%) 
IMPULSIVE BEHAVIOUR  1  0/86 (0.00%)  1/174 (0.57%)  0/70 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
ASTHMA  1  0/86 (0.00%)  1/174 (0.57%)  0/70 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   73/86 (84.88%)   136/174 (78.16%)   61/70 (87.14%) 
Gastrointestinal disorders       
NAUSEA  1  3/86 (3.49%)  2/174 (1.15%)  4/70 (5.71%) 
VOMITING  1  17/86 (19.77%)  34/174 (19.54%)  11/70 (15.71%) 
DIARRHOEA  1  7/86 (8.14%)  15/174 (8.62%)  8/70 (11.43%) 
CONSTIPATION  1  6/86 (6.98%)  7/174 (4.02%)  4/70 (5.71%) 
General disorders       
FATIGUE  1  7/86 (8.14%)  9/174 (5.17%)  7/70 (10.00%) 
PYREXIA  1  6/86 (6.98%)  23/174 (13.22%)  10/70 (14.29%) 
IRRITABILITY  1  4/86 (4.65%)  10/174 (5.75%)  1/70 (1.43%) 
Infections and infestations       
SINUSITIS  1  7/86 (8.14%)  10/174 (5.75%)  2/70 (2.86%) 
EAR INFECTION  1  3/86 (3.49%)  15/174 (8.62%)  2/70 (2.86%) 
NASOPHARYNGITIS  1  12/86 (13.95%)  22/174 (12.64%)  10/70 (14.29%) 
GASTROENTERITIS VIRAL  1  5/86 (5.81%)  8/174 (4.60%)  1/70 (1.43%) 
UPPER RESPIRATORY TRACT INFECTION  1  11/86 (12.79%)  16/174 (9.20%)  11/70 (15.71%) 
Investigations       
WEIGHT INCREASED  1  20/86 (23.26%)  40/174 (22.99%)  16/70 (22.86%) 
Metabolism and nutrition disorders       
DECREASED APPETITE  1  6/86 (6.98%)  7/174 (4.02%)  2/70 (2.86%) 
INCREASED APPETITE  1  16/86 (18.60%)  19/174 (10.92%)  8/70 (11.43%) 
Nervous system disorders       
DROOLING  1  3/86 (3.49%)  16/174 (9.20%)  3/70 (4.29%) 
HEADACHE  1  7/86 (8.14%)  18/174 (10.34%)  7/70 (10.00%) 
LETHARGY  1  7/86 (8.14%)  2/174 (1.15%)  1/70 (1.43%) 
SEDATION  1  8/86 (9.30%)  9/174 (5.17%)  10/70 (14.29%) 
DYSKINESIA  1  5/86 (5.81%)  3/174 (1.72%)  0/70 (0.00%) 
SOMNOLENCE  1  4/86 (4.65%)  3/174 (1.72%)  6/70 (8.57%) 
Psychiatric disorders       
TIC  1  0/86 (0.00%)  2/174 (1.15%)  6/70 (8.57%) 
ANXIETY  1  3/86 (3.49%)  10/174 (5.75%)  0/70 (0.00%) 
INSOMNIA  1  8/86 (9.30%)  17/174 (9.77%)  8/70 (11.43%) 
AGITATION  1  8/86 (9.30%)  11/174 (6.32%)  2/70 (2.86%) 
AGGRESSION  1  8/86 (9.30%)  15/174 (8.62%)  6/70 (8.57%) 
Renal and urinary disorders       
ENURESIS  1  5/86 (5.81%)  6/174 (3.45%)  4/70 (5.71%) 
Respiratory, thoracic and mediastinal disorders       
COUGH  1  10/86 (11.63%)  15/174 (8.62%)  6/70 (8.57%) 
EPISTAXIS  1  8/86 (9.30%)  10/174 (5.75%)  3/70 (4.29%) 
NASAL CONGESTION  1  10/86 (11.63%)  10/174 (5.75%)  0/70 (0.00%) 
RESPIRATORY TRACT CONGESTION  1  1/86 (1.16%)  2/174 (1.15%)  4/70 (5.71%) 
Skin and subcutaneous tissue disorders       
RASH  1  5/86 (5.81%)  7/174 (4.02%)  3/70 (4.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
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Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
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Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00365859     History of Changes
Other Study ID Numbers: CN138-180
First Submitted: August 15, 2006
First Posted: August 18, 2006
Results First Submitted: December 17, 2009
Results First Posted: January 25, 2010
Last Update Posted: December 2, 2013