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A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT00645099
First received: March 24, 2008
Last updated: April 24, 2014
Last verified: April 2014
Results First Received: April 7, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: olanzapine
Drug: paliperidone ER

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three subjects of the 462 enrolled did not receive study medication and were excluded from analysis: 2 subjects were randomized by mistake by the investigator and 1 subject withdrew consent before first intake of study medication. The ITT population consisted of 459 subjects who took at least one dose of study medication.

Reporting Groups
  Description
Paliperidone Extended Release (ER) 6-mg or 9-mg tablet once daily flexible dosing for 6 months
Olanzapine 10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months

Participant Flow:   Overall Study
    Paliperidone Extended Release (ER)   Olanzapine
STARTED   239   220 
COMPLETED   168   178 
NOT COMPLETED   71   42 
Lack of Efficacy                15                6 
Withdrawal by Subject                30                22 
Lost to Follow-up                6                4 
Adverse Event                11                5 
Other                9                5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Paliperidone ER 6-mg or 9-mg tablet once daily flexible dosing for 6 months
Olanzapine 10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
Total Total of all reporting groups

Baseline Measures
   Paliperidone ER   Olanzapine   Total 
Overall Participants Analyzed 
[Units: Participants]
 239   220   459 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.8  (11.1)   37.5  (11.4)   38.2  (11.2) 
Gender 
[Units: Participants]
     
Female   106   87   193 
Male   133   133   266 
Body Mass Index (BMI) 
[Units: Kg/m²]
Mean (Standard Deviation)
 26.9  (6.31)   27.0  (5.73)   26.9  (6.03) 
Waist 
[Units: Cm]
Mean (Standard Deviation)
 92.2  (14.4)   93.3  (15.6)   92.7  (14.9) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 75.9  (17.0)   77.9  (16.5)   76.9  (16.8) 


  Outcome Measures
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1.  Primary:   Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio)   [ Time Frame: Baseline to End Point (up to 6 months) ]

2.  Secondary:   Change From Baseline to End Point in Triglycerides   [ Time Frame: Baseline to End Point (up to 6 months) ]

3.  Secondary:   Change From Baseline to End Point in High Density Lipoprotein   [ Time Frame: Baseline to End Point (up to 6 months) ]

4.  Secondary:   Change From Baseline to End Point in Total Cholesterol   [ Time Frame: Baseline to End Point (up to 6 months) ]

5.  Secondary:   Change From Baseline to End Point in Low Density Lipoprotein Cholesterol (Friedwald QT)   [ Time Frame: Baseline to End Point (up to 6 months) ]

6.  Secondary:   Change From Baseline to End Point in Converted Insulin   [ Time Frame: Baseline to End Point (up to 6 months) ]

7.  Secondary:   Change From Baseline to End Point in Fasting Glucose   [ Time Frame: Baseline to End Point (up to 6 months) ]

8.  Secondary:   Change From Baseline to End Point in Homeostatic Model Assessment of Beta-cell Function (HOMA-%B)   [ Time Frame: Baseline to End Point (up to 6 months) ]

9.  Secondary:   Change From Baseline to End Point in Homeastatic Model Assessment of Insulin Resistance (HOMA-IR)   [ Time Frame: Baseline to End Point (up to 6 months) ]

10.  Secondary:   Number of Patients Meeting the Criteria for Type 2 Diabetes Mellitus During Follow-up   [ Time Frame: 6 months ]

11.  Secondary:   Number of Patients With Onset of Impaired Glucose Tolerance   [ Time Frame: Baseline to End Point (up to 6 months) ]

12.  Secondary:   Number of Patients With Impaired Fasting Glucose   [ Time Frame: Baseline to End Point (up to 6 months) ]

13.  Secondary:   Change From Baseline at End Point of the Insulinogenic Index   [ Time Frame: Baseline to End Point (up to 6 months) ]

14.  Secondary:   Change From Baseline at End Point of Mari-Type Analysis of Glucose Sensitivity for Insulin   [ Time Frame: Baseline to End Point (up to 6 months) ]

15.  Secondary:   Change From Baseline at End Point in Body Weight   [ Time Frame: Baseline to End Point (up to 6 months) ]

16.  Secondary:   Change From Baseline at End Point in Body Mass Index (BMI)   [ Time Frame: Baseline to End Point (up to 6 months) ]

17.  Secondary:   Change From Baseline at End Point in Waist Circumference   [ Time Frame: Baseline to End Point (up to 6 months) ]

18.  Secondary:   Number of Patients First Meeting the NCEP/ATP III Criteria for Metabolic Syndrome During Follow-up   [ Time Frame: 6 months ]

19.  Secondary:   Change From Baseline to End Point in Total Positive and Negative Syndrome Scale Score (PANSS)   [ Time Frame: Baseline to End Point (up to 6 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Open-label design


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: EMEA Therapeutic Area Leader CNS
Organization: Janssen-Cilag Germany
phone: +492137955153



Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT00645099     History of Changes
Other Study ID Numbers: CR013189
R076477SCH3020
Study First Received: March 24, 2008
Results First Received: April 7, 2010
Last Updated: April 24, 2014
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
Spain: Comité Ético de Investigación Clínica