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Trial record 18 of 408 for:    ARIPIPRAZOLE

Oral Aripiprazole Open-Label Rollover Study

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: NCT01001702
Recruitment Status : Completed
First Posted : October 27, 2009
Results First Posted : September 27, 2013
Last Update Posted : September 27, 2013
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Aripiprazole
Enrollment 85
Recruitment Details  
Pre-assignment Details An open-label rollover study for participants who completed study 31-03-241 (NCT00102518). The withdrawal criteria for this open label rollover study was completion by 31 December 2012 (or if Month 72 occurred within 6 months of this date) or if there was commercial availability.
Arm/Group Title Oral Aripiprazole
Hide Arm/Group Description Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Period Title: Overall Study
Started 85
Completed 13
Not Completed 72
Reason Not Completed
Lost to Follow-up             7
Adverse Event             7
Sponsor Discontinued Study             4
Subject met Withdrawal Criteria             22
Investigator withdrew Subject             10
Withdrawal by Subject             19
Lack of Efficacy per Investigator             3
Arm/Group Title Oral Aripiprazole
Hide Arm/Group Description Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Overall Number of Baseline Participants 85
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 85 participants
16.29  (1.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants
Female
42
  49.4%
Male
43
  50.6%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths
Hide Description

An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject. Change in clinical relevance (severity increased) was entered as a new AE in the current trial. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (clinically significant) change from baseline for that individual subject.

An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention.

Additional information about Adverse Events can be found in the Adverse Event section.

Time Frame Up to 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study drug.
Arm/Group Title Oral Aripiprazole
Hide Arm/Group Description:
Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Overall Number of Participants Analyzed 85
Measure Type: Number
Unit of Measure: Participants
AEs 61
SAEs 11
Discontinuation due to AEs 7
Death 1
2.Secondary Outcome
Title Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score
Hide Description

The rater or investigator answered the following question:

"Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices included: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. A negative change from Baseline indicated improvement

Time Frame Baseline, Last Visit (Up to 72 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with baseline assessment and at least one post-baseline measurement for analysis.
Arm/Group Title Oral Aripiprazole
Hide Arm/Group Description:
Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Overall Number of Participants Analyzed 84
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-0.26  (1.07)
3.Secondary Outcome
Title Number of Participants With Clinical Significant Laboratory Tests
Hide Description

Blood was collected for Fasting clinical laboratory tests (serum chemistry and hematology) at Baseline, Months 12, 24, 36, 48, 60, and 72 and were analyzed at a central laboratory.

Clinically significant values are defined as the following:

Bilirubin, total ≥ 2.0 mg/dL. Creatine phosphokinase > 500 U/L for participants 13-17 years or 3 times the upper limit of normal for participants ≥ 18 years [Reference Range (0 to 190 IU/L (females) and 0 to 235 IU/L (males)].

Eosinophils ≥ 10 %. Hematocrit < 30 % for participants 13-17 years old or ≥ 18 year old participants female ≤ 32 % and a 3 point decrease from baseline or male ≤ 37 % and a 3 point decrease from baseline.

Hemoglobin female ≤ 9.5 g/dL or male ≤ 11.5 g/dL. Prolactin > 1 times the upper limit of normal [Reference range: 2 to 18 ng/mL (males) and 3 to 30 ng/mL (females)].

Time Frame Baseline, Up to 72 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with at least one post-baseline numeric result for the given laboratory test are included in the analysis.
Arm/Group Title Oral Aripiprazole
Hide Arm/Group Description:
Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Overall Number of Participants Analyzed 79
Measure Type: Number
Unit of Measure: Participants
Bilirubin, total (mg/dL) 7
Creatine phosphokinase (CPK), total (IU/L) 6
Eosinophils (%) 5
Hematocrit (%) 5
Hemoglobin (g/dL) 3
Prolactin (ng/mL) 3
4.Secondary Outcome
Title Number of Participants With Clinically Significant Heart Rate
Hide Description Heart rate was measured at Baseline and at each visit supine (lying on the back) and standing. A heart rate increase is an increase of ≥ 15 beats per minute (bpm) compared to Baseline. A heart rate decrease is a decrease of ≥ 15 bpm compared to Baseline.
Time Frame Baseline, Up to 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.
Arm/Group Title Oral Aripiprazole
Hide Arm/Group Description:
Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Overall Number of Participants Analyzed 84
Measure Type: Number
Unit of Measure: Participants
Supine Heart Rate Increase 0
Supine Heart Rate Decrease 0
Standing Heart Rate Increase 1
Standing Heart Rate Decrease 0
5.Secondary Outcome
Title Number of Participants With Clinically Significant Blood Pressure
Hide Description

Systolic and Diastolic blood pressure was measured at Baseline and at all visits supine (lying on the back) and standing.

Systolic increase was an increase of ≥ 20 mm Hg compared to Baseline and systolic decrease was a decrease of ≥ 20 mm Hg compared to Baseline.

A diastolic increase was an increase of ≥ 15 mm Hg compared to Baseline and a diastolic decrease was a decrease of ≥ 15 mm Hg compared to Baseline.

Time Frame Baseline, Up to 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.
Arm/Group Title Oral Aripiprazole
Hide Arm/Group Description:
Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Overall Number of Participants Analyzed 84
Measure Type: Number
Unit of Measure: Participants
Supine Systolic Blood Pressure Increase 4
Supine Systolic Blood Pressure Decrease 3
Standing Systolic Blood Pressure Increase 5
Standing Systolic Blood Pressure Decrease 2
Supine Diastolic Blood Pressure Increase 5
Supine Diastolic Blood Pressure Decrease 0
Standing Diastolic Blood Pressure Increase 5
Standing Diastolic Blood Pressure Decrease 0
6.Secondary Outcome
Title Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations
Hide Description

A 12-lead ECG was recorded at Baseline, Months 6, 12, 24, 36, 48, 60 and 72. Three readings taken 5 minutes were read by a central ECG reading service and averaged.

Clinically significant ECGs were defined as:

Sinus Bradycardia: ≤ 50 beats per minute (bpm), decrease of ≥ 15 bpm from Baseline.

Supraventricular premature beat: ≥ 2 per 10 seconds, increase from Baseline. Ventricular premature beat: ≥ 1 per 10 seconds, increase from Baseline. Right bundle branch block: present. Other intraventricular block: QRS ≥ 0.10 seconds for age 13-17 years or QRS ≥ 0.11 seconds for age ≥ 18 years, an increase of ≥ 0.02 seconds from Baseline.

Symmetrical T-wave inversion: present. QTcB (QT interval corrected Bazett’s formula), QTcF (QT interval corrected Fridericia’s formula), QTcN (QT corrected FDA Neuropharmacology Division formula), QTcE (QT corrected fractional exponent correction method: ≥ 420 msec for age 13-17 years or ≥ 450 msec for age ≥ 18 years, ≥ 10 % increase from Baseline.

Time Frame Baseline, Up to 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with at least one post-baseline numeric result for the given parameter.
Arm/Group Title Oral Aripiprazole
Hide Arm/Group Description:
Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Overall Number of Participants Analyzed 82
Measure Type: Number
Unit of Measure: Participants
Sinus bradycardia 7
Supraventricular premature beat 6
Ventricular premature beat 1
Right bundle branch block 1
Other intraventricular block 5
Symmetrical T-wave inversion 1
QTcB 9
QTcF 4
QTcN 6
QTcE 5
7.Secondary Outcome
Title Number of Participants Showing Significant Weight Gain or Loss
Hide Description Weight was measured at Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72. A clinically significant weight gain was defined as a ≥ 7 % increase from Baseline. A clinically significant Weight loss was defined as a ≥ 7% decrease from Baseline.
Time Frame Baseline, Up to 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.
Arm/Group Title Oral Aripiprazole
Hide Arm/Group Description:
Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Overall Number of Participants Analyzed 82
Measure Type: Number
Unit of Measure: Participants
Weight Gain 37
Weight Loss 4
8.Secondary Outcome
Title Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description The C-SSRS consisted of a baseline evaluation (completed at the first scheduled visit upon approval of protocol Amendment 3) that assessed the lifetime experience of the participant with suicide events and suicidal ideation and a post-baseline evaluation at each visit that focused on suicidality since the last trial visit. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). The number of participants experiencing suicidal ideation or suicidal behavior is reported.
Time Frame Baseline, Up to 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available assessment.
Arm/Group Title Oral Aripiprazole
Hide Arm/Group Description:
Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Aripiprazole
Hide Arm/Group Description Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
All-Cause Mortality
Oral Aripiprazole
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oral Aripiprazole
Affected / at Risk (%)
Total   11/85 (12.94%) 
Infections and infestations   
Pneumonia bacterial  1  1/85 (1.18%) 
Injury, poisoning and procedural complications   
Ligament rupture  1  1/85 (1.18%) 
Nervous system disorders   
Psychomotor hyperactivity  1  1/85 (1.18%) 
Psychiatric disorders   
Aggression  1  1/85 (1.18%) 
Impulsive behaviour  1  1/85 (1.18%) 
Psychotic disorder  1  1/85 (1.18%) 
Schizophrenia  1  2/85 (2.35%) 
Suicide attempt  1  3/85 (3.53%) 
Social circumstances   
Social stay hospitalisation  1  1/85 (1.18%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oral Aripiprazole
Affected / at Risk (%)
Total   45/85 (52.94%) 
Gastrointestinal disorders   
Nausea  1  5/85 (5.88%) 
Vomiting  1  7/85 (8.24%) 
General disorders   
Pain  1  7/85 (8.24%) 
Pyrexia  1  8/85 (9.41%) 
Infections and infestations   
Influenza  1  9/85 (10.59%) 
Nasopharyngitis  1  6/85 (7.06%) 
Investigations   
Weight increased  1  9/85 (10.59%) 
Metabolism and nutrition disorders   
Decreased appetite  1  5/85 (5.88%) 
Nervous system disorders   
Headache  1  13/85 (15.29%) 
Somnolence  1  5/85 (5.88%) 
Psychiatric disorders   
Anxiety  1  5/85 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/85 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Affair
Organization: Otsuka Pharmaceutical Development and Commercialization
Phone: 800 562-3974
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01001702     History of Changes
Other Study ID Numbers: 31-05-243
First Submitted: October 22, 2009
First Posted: October 27, 2009
Results First Submitted: July 29, 2013
Results First Posted: September 27, 2013
Last Update Posted: September 27, 2013