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Oral Aripiprazole Open-Label Rollover Study

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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.

Tracking Information
First Submitted Date  ICMJE October 22, 2009
First Posted Date  ICMJE October 27, 2009
Results First Submitted Date  ICMJE July 29, 2013
Results First Posted Date  ICMJE September 27, 2013
Last Update Posted Date September 27, 2013
Study Start Date  ICMJE April 2006
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2013)
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths [ Time Frame: Up to 72 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2009)
  • Frequency and severity of adverse events [ Time Frame: 3 years ]
  • Severity of serious adverse events (including adverse events related to laboratory abnormalities) [ Time Frame: 3 years ]
  • Rates of discontinuation from study due to adverse events [ Time Frame: 3 years ]
Change History Complete list of historical versions of study NCT01001702 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2013)
  • Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score [ Time Frame: Baseline, Last Visit (Up to 72 Months) ]
    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
  • Number of Participants With Clinical Significant Laboratory Tests [ Time Frame: Baseline, Up to 72 Months ]
    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)].
  • Number of Participants With Clinically Significant Heart Rate [ Time Frame: Baseline, Up to 72 months ]
    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.
  • Number of Participants With Clinically Significant Blood Pressure [ Time Frame: Baseline, Up to 72 months ]
    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.
  • Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations [ Time Frame: Baseline, Up to 72 months ]
    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.
  • Number of Participants Showing Significant Weight Gain or Loss [ Time Frame: Baseline, Up to 72 months ]
    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.
  • Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline, Up to 72 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2009)
Mean change from baseline of vital signs parameters and laboratory tests [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Aripiprazole Open-Label Rollover Study
Official Title  ICMJE An Open- Label Rollover Study for Subjects With Schizophrenia Completing ABILIFY® (Aripiprazole) Clinical Study 31-03-241
Brief Summary The purpose of this study is to test the long-term safety and tolerability of oral aripiprazole in adolescent patients with schizophrenia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: Aripiprazole
Flexible dose between 5 mg and 30 mg Aripiprazole tablets.
Other Name: ABILIFY®
Study Arms  ICMJE Experimental: Oral Aripiprazole
Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Intervention: Drug: Aripiprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2009)
85
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with a confirmed Axis I Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia who must have completed Otsuka study 31-03-241 (NCT00102518) treatment of adolescent subjects with schizophrenia

Exclusion Criteria:

  • Patients with a co-morbid serious, uncontrolled systemic illness
  • Patients with a significant risk of committing suicide
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Croatia,   India,   Russian Federation,   Serbia,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01001702
Other Study ID Numbers  ICMJE 31-05-243
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor  ICMJE Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP