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A Study to Evaluate Participants Satisfaction, Quality of Life and Effectiveness of Flexible-Dose of Paliperidone Extended Release (ER) in Participants With Schizophrenia, Previously Treated With Risperidone

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ClinicalTrials.gov Identifier: NCT01010776
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : November 20, 2013
Last Update Posted : November 20, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Farmaceutica Ltda.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Paliperidone Extended Release (ER)
Enrollment 223
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
Period Title: Main Phase
Started 223
Treated 218
Completed 174
Not Completed 49
Reason Not Completed
Withdrawal by Subject             14
Lack of Efficacy             8
Adverse Event             7
Lost to Follow-up             6
Non-compliance to study medication             5
Selection failure             2
Inform consent withdrawal             1
Not specified             1
Did not received study medication             5
Period Title: In-Between Main Phase & Extension Phase
Started 174
Completed 159
Not Completed 15
Reason Not Completed
Extension phase was optional             15
Period Title: Extension Phase
Started 159
Completed 156
Not Completed 3
Reason Not Completed
Not specified             3
Arm/Group Title Paliperidone ER - Main Phase Plus Extension Phase
Hide Arm/Group Description Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Baseline Participants 218
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 218 participants
37.87  (11.01)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 218 participants
18-21 years 14
22-29 years 50
30-39 years 51
40-49 years 67
50-60 years 35
61-69 years 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants
Female
79
  36.2%
Male
139
  63.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 218 participants
White/Caucasian 120
Black 52
Oriental 3
Mulatto 9
Brown 34
Positive and Negative Syndrome Scale (PANSS) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 218 participants
94.49  (12.38)
[1]
Measure Description: The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Positive and Negative PANSS Subscales Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 218 participants
Positive PANSS Subscale Score 27.37  (6.48)
Negative PANSS Subscale Score 19.76  (5.79)
[1]
Measure Description: The PANSS positive subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS negative subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Personal and Social Performance (PSP) Scale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 218 participants
44.39  (13.11)
[1]
Measure Description: The PSP assesses the degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.
Pittsburg Sleep Quality Index (PSQI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 218 participants
6.7  (4.1)
[1]
Measure Description: The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.
1.Primary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase
Hide Description The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat for effectiveness (ITTe) population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Last Observation Carried Forward (LOCF) method was used.
Arm/Group Title Paliperidone Extended Release (ER) - Main Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 213
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-22.9  (20.1)
2.Primary Outcome
Title Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase
Hide Description The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.
Arm/Group Title Paliperidone (ER) - Main Phase Plus Extension Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 159
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 93.25  (11.6)
Change at Week 52 -26.4  (17.5)
3.Secondary Outcome
Title Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase
Hide Description Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.
Arm/Group Title Paliperidone ER-Main Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 213
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
60.1
(53.2 to 66.7)
4.Secondary Outcome
Title Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase
Hide Description Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.
Arm/Group Title Paliperidone ER-Main Phase Plus Extension Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 159
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
71.1
(63.4 to 78.0)
5.Secondary Outcome
Title Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase
Hide Description The PANSS positive subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS negative subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Time Frame Baseline, Week 4, 8, 13 and 26
Hide Outcome Measure Data
Hide Analysis Population Description
The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'N' specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.
Arm/Group Title Paliperidone ER-Main Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 203
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 4: PANSS positive subscale (n=201) -3.6  (4.8)
Change at Week 4: PANSS negative subscale (n=201) -3.6  (4.8)
Change at Week 8: PANSS positive subscale (n=191) -5.0  (5.8)
Change at Week 8: PANSS negative subscale (n=191) -5.0  (5.8)
Change at Week 13: PANSS positive subscale (n=182) -5.9  (5.8)
Change at Week 13: PANSS negative subscale (n=182) -5.9  (5.8)
Change at Week 26: PANSS positive subscale (n=203) -5.9  (6.2)
Change at Week 26: PANSS negative subscale (n=203) -5.9  (6.2)
6.Secondary Outcome
Title Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
Hide Description The PANSS Positive Subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Time Frame Baseline, Week 4, 8, 13, 26, 39 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.
Arm/Group Title Paliperidone ER-Main Phase Plus Extension Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 159
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline: PANSS positive subscale (n=159) 26.65  (6.20)
Baseline: PANSS negative subscale (n=159) 19.25  (5.86)
Change at Week 4: PANSS positive subscale (n=159) -3.4  (4.4)
Change at Week 4: PANSS negative subscale (n=159) -3.4  (4.4)
Change at Week 8: PANSS positive subscale (n=159) -5.4  (5.1)
Change at Week 8: PANSS negative subscale (n=159) -5.4  (5.1)
Change at Week 13: PANSS positive subscale (n=159) -5.9  (5.7)
Change at Week 13: PANSS negative subscale (n=159) -5.9  (5.7)
Change at Week 26: PANSS positive subscale (n=159) -6.8  (5.5)
Change at Week 26: PANSS negative subscale (n=159) -6.8  (5.5)
Change at Week 39: PANSS positive subcale (n=152) -7.3  (5.9)
Change at Week 39: PANSS negative subscale (n=152) -7.3  (5.9)
Change at Week 52: PANSS positive subscale (n=154) -7.5  (6.1)
Change at Week 52: PANSS negative subscale (n=154) -7.5  (6.1)
7.Secondary Outcome
Title Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase
Hide Description The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.
Time Frame Baseline, Week 4, 8, 13 and 26
Hide Outcome Measure Data
Hide Analysis Population Description
The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.
Arm/Group Title Paliperidone ER-Main Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 204
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 4 (n=201) 5.7  (11.7)
Change at Week 8 (n=191) 8.3  (12.8)
Change at Week 13 (n=182) 9.9  (14.8)
Change at Week 26 (n=204) 10.4  (14.9)
8.Secondary Outcome
Title Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
Hide Description The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.
Time Frame Baseline, Week 4, 8, 13, 26, 39 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.
Arm/Group Title Paliperidone ER-Main Phase Plus Extension Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 159
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=159) 45.17  (12.84)
Change at Week 4 (n=159) 5.3  (9.6)
Change at Week 8 (n=159) 9.0  (12.6)
Change at Week 13 (n=159) 9.7  (14.4)
Change at Week 26 (n=159) 12.0  (12.7)
Change at Week 39 (n=151) 12.6  (14.2)
Change at Week 52 (n=155) 14.6  (14.9)
9.Secondary Outcome
Title Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase
Hide Description The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.
Time Frame Baseline, Week 4, 8, 13 and 26
Hide Outcome Measure Data
Hide Analysis Population Description
The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.
Arm/Group Title Paliperidone ER-Main Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 198
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=198) 6.7  (4.1)
Change at Week 4 (n=174) -1.0  (3.5)
Change at Week 8 (n=162) -1.2  (3.5)
Change at Week 13 (n=156) -1.5  (3.3)
Change at Week 26 (n=174) -1.4  (3.7)
10.Secondary Outcome
Title Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
Hide Description The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.
Time Frame Baseline, Week 4, 8, 13, 26, 39 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.
Arm/Group Title Paliperidone ER-Main Phase Plus Extension Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 148
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=148) 6.4  (4.1)
Change at Week 4 (n=140) -1.0  (3.6)
Change at Week 8 (n=136) -1.3  (3.2)
Change at Week 13 (137) -1.5  (3.2)
Change at Week 26 (n=135) -1.4  (3.5)
Change at Week 39 (n=133) -1.9  (3.9)
Change at Week 52 (n=133) -1.9  (3.4)
11.Secondary Outcome
Title Number of Participants With Clinical Global Impression–Severity (CGI-S) Score - Main Phase
Hide Description The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1="Normal, not at all ill" and a rating of 7 ="Among the most extremely ill participants". Higher scores indicate worsening.
Time Frame Baseline, Week 4, 8, 13 and 26
Hide Outcome Measure Data
Hide Analysis Population Description
The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.
Arm/Group Title Paliperidone ER-Main Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 213
Measure Type: Number
Unit of Measure: Participants
Baseline: Borderline (n=213) 2
Baseline: Slightly ill (n=213) 4
Baseline: Moderately ill (n=213) 52
Baseline: Markedly ill (n=213) 114
Baseline: Severely ill (n=213) 40
Baseline: Extremely ill (n=213) 1
Week 4: Borderline (n=201) 4
Week 4: Slightly ill (n=201) 25
Week 4: Moderately ill (n=201) 87
Week 4: Markedly ill (n=201) 61
Week 4: Severely ill (n=201) 24
Week 8: Borderline (n=191) 5
Week 8: Slightly ill (n=191) 35
Week 8: Moderately ill (n=191) 80
Week 8: Markedly ill (n=191) 56
Week 8: Severely ill (n=191) 15
Week 8: extremely ill (n=191) 0
Week 13: Normal, without any disease (n=182) 2
Week 13: Borderline (n=182) 7
Week 13: Slightly ill (n=182) 41
Week 13: Moderately ill (n=182) 73
Week 13: Markedly ill (n=182) 47
Week 13: Severly ill (n=182) 12
Week 26: Normal without any disease (n=204) 3
Week 26: Borderline (n=204) 16
Week 26: Slightly ill (n=204) 48
Week 26: Moderately ill (n=204) 70
Week 26: Markedely ill (n=204) 48
Week 26: Severely ill (n=204) 19
12.Secondary Outcome
Title Number of Participants With Clinical Global Impression–Severity (CGI-S) Score - Extension Phase
Hide Description The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1="Normal, not at all ill" and a rating of 7 ="Among the most extremely ill participants". Higher scores indicate worsening.
Time Frame Week 39 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.
Arm/Group Title Paliperidone ER - Extension Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally, once daily for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 155
Measure Type: Number
Unit of Measure: Participants
Week 39: Normal without any disease (n=152) 2
Week 39: Borderline (n=152) 22
Week 39: Slightly ill (n=152) 41
Week 39: Moderately ill (n=152) 55
Week 39: Markedely ill (n=152) 22
Week 39: Severely ill (n=152) 10
Week 52: Borderline (n=155) 23
Week 52: Slightly ill (n=155) 37
Week 52: Moderately ill (n=155) 58
Week 52: Markedely ill (n=155) 24
Week 52: Severely ill (n=155) 10
13.Secondary Outcome
Title Percentage of Participants With Treatment Satisfaction - Main Phase
Hide Description Participant’s response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.
Time Frame Baseline, Week 4, 8, 13 and 26
Hide Outcome Measure Data
Hide Analysis Population Description
The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.
Arm/Group Title Paliperidone ER - Main Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 213
Measure Type: Number
Unit of Measure: Percentage of Participants
Baseline: Very good (n=213) 11.7
Baseline: Good (n=213) 38.5
Baseline: Moderate (n=213) 34.3
Baseline: Bad (n=213) 12.7
Baseline: Very bad (n=213) 2.8
Week 4: Very good (n=200) 29.5
Week 4: Good (n=200) 52.5
Week 4: Moderate (n=200) 16.5
Week 4: Bad (n=200) 1.0
Week 4: Very bad (n=200) 0.5
Week 8: Very good (n=190) 33.7
Week 8: Good (n=190) 48.9
Week 8: Moderate (n=190) 13.7
Week 8: Bad (n=190) 3.7
Week 13: Very good (n=182) 37.4
Week 13: Good (n=182) 46.2
Week 13: Moderate (n=182) 12.1
Week 13: Bad (n=182) 3.8
Week 13: Very bad (n=182) 0.5
Week 26: Very good (n=204) 36.3
Week 26: Good (n=204) 46.1
Week 26: Moderate (n=204) 10.8
Week 26: Bad (n=204) 4.4
Week 26: Very bad (n=204) 2.5
14.Secondary Outcome
Title Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase
Hide Description Participant’s response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.
Time Frame Baseline, Week 4, 8, 13, 26, 39 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.
Arm/Group Title Paliperidone ER-Main Phase Plus Extension Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 159
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline: Very good (n=159) 13.2
Baseline: Good (n=159) 40.9
Baseline: Moderate (n=159) 32.1
Baseline: Bad (n=159) 11.3
Baseline: Very bad (n=159) 2.5
Week 4: Very good (n=159) 31.4
Week 4: Good (n=159) 54.1
Week 4: Moderate (n=159) 13.8
Week 4: Very bad (n=159) 0.6
Week 8: Very good (n=159) 37.1
Week 8: Moderate (n=159) 11.3
Week 8: Bad (n=159) 3.1
Week 13: Very good (n=159) 39.0
Week 13: Good (n=159) 46.5
Week 13: Moderate (n=159) 10.1
Week 13: Bad (n=159) 3.8
Week 13: Very bad (n=159) 0.6
Week 26: Very good (n=159) 41.5
Week 26: Good (n=159) 50.9
Week 26: Moderate (n=159) 6.9
Week 26: Very bad (n=159) 0.6
Week 39: Very good (n=152) 38.8
Week 39: Good (n=152) 51.3
Week 39: Moderate (n=152) 7.2
Week 39: Bad (n=152) 2.0
Week 39: Very bad (n=152) 0.7
Week 52: Very good (n=155) 41.3
Week 52: Good (n=155) 43.2
Week 52: Moderate (n=155) 12.9
Week 52: Bad (n=155) 2.6
15.Secondary Outcome
Title 36-Item Short-Form Health Survey (SF-36) Score - Main Phase
Hide Description The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure.
Arm/Group Title Paliperidone ER- Main Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 190
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline: Physical component summary 47.9  (8.8)
Baseline: Mental component summary 35.9  (8.5)
Week 26: Physical component summary 48.4  (7.6)
Week 26: Mental component summary 38.3  (8.0)
16.Secondary Outcome
Title 36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase
Hide Description The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure.
Arm/Group Title Paliperidone ER-Main Phase Plus Extension Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline: Physical component summary 48.7  (8.6)
Baseline: Mental component summary 35.7  (8.5)
Week 52: Physical component summary 48.8  (7.6)
Week 52: Mental component summary 38.5  (8.4)
17.Other Pre-specified Outcome
Title Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase
Hide Description An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.
Time Frame Baseline, Week 4, 8, 13 and 26
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all the participants that received at least one dose of study medication and provided any post-baseline information. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.
Arm/Group Title Paliperidone ER - Main Phase
Hide Arm/Group Description:
Single oral dose of paliperidone ER tablet within the range of 3 to 12 mg once a day was administered for 26 weeks. Dosage was adjusted as per the investigator’s discretion.
Overall Number of Participants Analyzed 215
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=215) 1.30  (1.99)
Change at Week 4 (n=201) -0.40  (1.23)
Change at Week 8 (n=189) -0.45  (1.47)
Change at Week 13 (n=182) -0.63  (1.76)
Change at Week 26 (n=201) -0.6  (1.71)
18.Other Pre-specified Outcome
Title Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
Hide Description An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.
Time Frame Baseline, Week 4, 8, 13, 26, 39 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.
Arm/Group Title Paliperidone ER-Main Plus Extension Phase
Hide Arm/Group Description:
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
Overall Number of Participants Analyzed 159
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=159) 1.41  (2.14)
Change at Week 4 (n=159) -0.51  (1.31)
Change at Week 8 (n=159) -0.49  (1.56)
Change at Week 13 (n=159) -0.68  (1.85)
Change at Week 26 (n=158) -0.77  (1.87)
Change at Week 39 (n=151) -0.81  (1.97)
Change at Week 52 (n=154) -0.75  (1.94)
Time Frame Baseline up to Week 52
Adverse Event Reporting Description The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.
 
Arm/Group Title Paliperidone ER - Main Phase Paliperidone ER - Extension Phase
Hide Arm/Group Description Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion. Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
All-Cause Mortality
Paliperidone ER - Main Phase Paliperidone ER - Extension Phase
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone ER - Main Phase Paliperidone ER - Extension Phase
Affected / at Risk (%) Affected / at Risk (%)
Total   14/215 (6.51%)   3/159 (1.89%) 
Metabolism and nutrition disorders     
Hypokalemia * 1  1/215 (0.47%)  0/159 (0.00%) 
Hyponatremia * 1  1/215 (0.47%)  0/159 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy NOS * 1  0/215 (0.00%)  1/159 (0.63%) 
Psychiatric disorders     
Depressed mood * 1  1/215 (0.47%)  0/159 (0.00%) 
Psychomotor agitation * 1  1/215 (0.47%)  0/159 (0.00%) 
Psychotic disorder NOS * 1  5/215 (2.33%)  0/159 (0.00%) 
Schizophrenia NOS * 1  2/215 (0.93%)  1/159 (0.63%) 
Suicidal ideation * 1  1/215 (0.47%)  0/159 (0.00%) 
Somatoform disorder * 1  1/215 (0.47%)  0/159 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Nasal septum deviation * 1  0/215 (0.00%)  1/159 (0.63%) 
Skin and subcutaneous tissue disorders     
Skin lesion NOS * 1  1/215 (0.47%)  0/159 (0.00%) 
Surgical and medical procedures     
Hospitalization * 1  2/215 (0.93%)  0/159 (0.00%) 
Cholecystectomy * 1  0/215 (0.00%)  1/159 (0.63%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Paliperidone ER - Main Phase Paliperidone ER - Extension Phase
Affected / at Risk (%) Affected / at Risk (%)
Total   144/215 (66.98%)   70/159 (44.03%) 
Cardiac disorders     
Tachycardia NOS * 1  1/215 (0.47%)  0/159 (0.00%) 
Ear and labyrinth disorders     
Vertigo * 1  1/215 (0.47%)  0/159 (0.00%) 
Eye disorders     
Eye pain * 1  1/215 (0.47%)  0/159 (0.00%) 
Eye movement disorder NOS * 1  1/215 (0.47%)  0/159 (0.00%) 
Gastrointestinal disorders     
Nausea * 1  5/215 (2.33%)  1/159 (0.63%) 
Abdominal pain upper * 1  3/215 (1.40%)  1/159 (0.63%) 
Vomiting NOS * 1  2/215 (0.93%)  1/159 (0.63%) 
Salivary hypersecretion * 1  3/215 (1.40%)  0/159 (0.00%) 
Constipation * 1  1/215 (0.47%)  1/159 (0.63%) 
Toothache * 1  1/215 (0.47%)  0/159 (0.00%) 
Gastritis NOS * 1  0/215 (0.00%)  1/159 (0.63%) 
Food poisoning NOS * 1  1/215 (0.47%)  0/159 (0.00%) 
Aptyalism * 1  1/215 (0.47%)  0/159 (0.00%) 
General disorders     
Malaise * 1  3/215 (1.40%)  0/159 (0.00%) 
Pain NOS * 1  1/215 (0.47%)  1/159 (0.63%) 
Influenza like illness * 1  2/215 (0.93%)  0/159 (0.00%) 
Asthenia * 1  1/215 (0.47%)  1/159 (0.63%) 
Feeling abnormal * 1  1/215 (0.47%)  0/159 (0.00%) 
Fatigue * 1  1/215 (0.47%)  0/159 (0.00%) 
Chest pain * 1  1/215 (0.47%)  0/159 (0.00%) 
Pyrexia * 1  0/215 (0.00%)  1/159 (0.63%) 
Immune system disorders     
Hypersensitivity NOS * 1  1/215 (0.47%)  0/159 (0.00%) 
Infections and infestations     
Nasopharyngitis * 1  1/215 (0.47%)  1/159 (0.63%) 
Infected sebaceous cyst * 1  1/215 (0.47%)  0/159 (0.00%) 
Sinusitis NOS * 1  0/215 (0.00%)  1/159 (0.63%) 
Urinary tract infection * 1  1/215 (0.47%)  0/159 (0.00%) 
Respiratory tract infection * 1  0/215 (0.00%)  1/159 (0.63%) 
Breast abscess * 1  0/215 (0.00%)  1/159 (0.63%) 
Injury, poisoning and procedural complications     
Lower limb fracture NOS * 1  1/215 (0.47%)  0/159 (0.00%) 
Investigations     
Weight increased * 1  23/215 (10.70%)  20/159 (12.58%) 
Weight decreased * 1  5/215 (2.33%)  5/159 (3.14%) 
Blood triglycerides increased * 1  2/215 (0.93%)  2/159 (1.26%) 
Blood prolactin increased * 1  0/215 (0.00%)  2/159 (1.26%) 
Metabolism and nutrition disorders     
Dyslipidemia * 1  2/215 (0.93%)  2/159 (1.26%) 
Diabetes mellitus NOS * 1  2/215 (0.93%)  2/159 (1.26%) 
Appetite decreased NOS * 1  3/215 (1.40%)  0/159 (0.00%) 
Appetite increased NOS * 1  2/215 (0.93%)  0/159 (0.00%) 
Anorexia * 1  1/215 (0.47%)  1/159 (0.63%) 
Hyponatremia * 1  1/215 (0.47%)  0/159 (0.00%) 
Hypokalemia * 1  1/215 (0.47%)  0/159 (0.00%) 
Hypertriglyceridemia * 1  0/215 (0.00%)  1/159 (0.63%) 
Hyperglycemia NOS * 1  0/215 (0.00%)  1/159 (0.63%) 
Fluid retention * 1  1/215 (0.47%)  0/159 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/215 (0.47%)  1/159 (0.63%) 
Muscle rigidity * 1  2/215 (0.93%)  0/159 (0.00%) 
Arthralgia * 1  1/215 (0.47%)  0/159 (0.00%) 
Pain in extremity * 1  1/215 (0.47%)  0/159 (0.00%) 
Skin lesion NOS * 1  1/215 (0.47%)  0/159 (0.00%) 
Acne NOS * 1  1/215 (0.47%)  0/159 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Mycosis fungoides NOS * 1  1/215 (0.47%)  0/159 (0.00%) 
Nervous system disorders     
Somnolence * 1  13/215 (6.05%)  4/159 (2.52%) 
Headache * 1  13/215 (6.05%)  4/159 (2.52%) 
Akathisia * 1  8/215 (3.72%)  5/159 (3.14%) 
Psychomotor hyperactivity * 1  8/215 (3.72%)  0/159 (0.00%) 
Tremor * 1  6/215 (2.79%)  0/159 (0.00%) 
Parkinsonism * 1  6/215 (2.79%)  0/159 (0.00%) 
Dizziness * 1  6/215 (2.79%)  0/159 (0.00%) 
Dystonia * 1  4/215 (1.86%)  0/159 (0.00%) 
Extrapyramidal disorder * 1  2/215 (0.93%)  1/159 (0.63%) 
Sedation * 1  3/215 (1.40%)  0/159 (0.00%) 
Aphonia * 1  1/215 (0.47%)  1/159 (0.63%) 
Ageusia * 1  1/215 (0.47%)  1/159 (0.63%) 
Speech disorder * 1  2/215 (0.93%)  0/159 (0.00%) 
Hypokinesia * 1  1/215 (0.47%)  0/159 (0.00%) 
Grand mal convulsion * 1  0/215 (0.00%)  1/159 (0.63%) 
Repetitive speech * 1  1/215 (0.47%)  0/159 (0.00%) 
Psychiatric disorders     
Insomnia * 1  32/215 (14.88%)  14/159 (8.81%) 
Anxiety * 1  23/215 (10.70%)  4/159 (2.52%) 
Depression * 1  8/215 (3.72%)  7/159 (4.40%) 
Agitation * 1  12/215 (5.58%)  0/159 (0.00%) 
Psychotic disorder NOS * 1  7/215 (3.26%)  0/159 (0.00%) 
Libido decreased * 1  3/215 (1.40%)  2/159 (1.26%) 
Schizophrenia NOS * 1  4/215 (1.86%)  0/159 (0.00%) 
Psychomotor retardation * 1  2/215 (0.93%)  1/159 (0.63%) 
Nervousness * 1  2/215 (0.93%)  1/159 (0.63%) 
Aggression * 1  2/215 (0.93%)  1/159 (0.63%) 
Logorrhea * 1  2/215 (0.93%)  0/159 (0.00%) 
Obsessive thoughts * 1  1/215 (0.47%)  1/159 (0.63%) 
Impulsive behavior NOS * 1  1/215 (0.47%)  1/159 (0.63%) 
Hostility * 1  1/215 (0.47%)  1/159 (0.63%) 
Hallucination NOS * 1  2/215 (0.93%)  0/159 (0.00%) 
Depressive symptom * 1  1/215 (0.47%)  1/159 (0.63%) 
Depressed mood * 1  2/215 (0.93%)  0/159 (0.00%) 
Confusional state * 1  2/215 (0.93%)  0/159 (0.00%) 
Sleep disorder NOS * 1  1/215 (0.47%)  0/159 (0.00%) 
Restlessness * 1  1/215 (0.47%)  0/159 (0.00%) 
Psychomotor agitation * 1  1/215 (0.47%)  0/159 (0.00%) 
Nightmare * 1  1/215 (0.47%)  0/159 (0.00%) 
Hallucination, auditory * 1  1/215 (0.47%)  0/159 (0.00%) 
Suicidal ideation * 1  1/215 (0.47%)  0/159 (0.00%) 
Reproductive system and breast disorders     
Erectile dysfunction NOS * 1  2/215 (0.93%)  2/159 (1.26%) 
Ejaculation failure * 1  1/215 (0.47%)  1/159 (0.63%) 
Breast discharge * 1  0/215 (0.00%)  1/159 (0.63%) 
Galactorrhea * 1  2/215 (0.93%)  3/159 (1.89%) 
Respiratory, thoracic and mediastinal disorders     
Snoring * 1  1/215 (0.47%)  0/159 (0.00%) 
Productive cough * 1  1/215 (0.47%)  0/159 (0.00%) 
Nasal septum deviation * 1  0/215 (0.00%)  1/159 (0.63%) 
Hiccups * 1  1/215 (0.47%)  0/159 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  2/215 (0.93%)  1/159 (0.63%) 
Surgical and medical procedures     
Hospitalization * 1  3/215 (1.40%)  0/159 (0.00%) 
Cholecystectomy * 1  0/215 (0.00%)  1/159 (0.63%) 
Vascular disorders     
Hypertension NOS * 1  4/215 (1.86%)  3/159 (1.89%) 
Hypertensive crisis * 1  1/215 (0.47%)  1/159 (0.63%) 
Orthostatic hypotension * 1  0/215 (0.00%)  1/159 (0.63%) 
Pallor * 1  1/215 (0.47%)  0/159 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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 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 from the time submitted to the sponsor for review. The Sponsor can require changes to the communication and can extend the embargo.
Results Point of Contact
Name/Title: Medical Group Manager
Organization: Jan-Cil Brazil
Phone: 55 11 3030-2770
Responsible Party: Janssen-Cilag Farmaceutica Ltda.
ClinicalTrials.gov Identifier: NCT01010776     History of Changes
Other Study ID Numbers: CR013744
R076477SCH4011 ( Other Identifier: Janssen-Cilag Farmaceutica Ltda. )
First Submitted: November 5, 2009
First Posted: November 10, 2009
Results First Submitted: April 15, 2013
Results First Posted: November 20, 2013
Last Update Posted: November 20, 2013