One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome

This study has been terminated.
(See Detailed Description)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00748566
First received: September 5, 2008
Last updated: April 29, 2013
Last verified: April 2013
Results First Received: April 29, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia and Disorders With Psychotic Features
Intervention: Drug: Ziprasidone HCL (oral)

  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
No text entered.

Reporting Groups
  Description
Ziprasidone Ziprasidone 40 milligram (mg) capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.

Participant Flow:   Overall Study
    Ziprasidone  
STARTED     172  
COMPLETED     60  
NOT COMPLETED     112  
Adverse Event                 49  
Death                 1  
Lack of Efficacy                 12  
Lost to Follow-up                 1  
Protocol Violation                 13  
Withdrawal by Subject                 22  
Study terminated by sponsor                 5  
Unspecified                 9  



  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
Ziprasidone Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.

Baseline Measures
    Ziprasidone  
Number of Participants  
[units: participants]
  172  
Age  
[units: years]
Mean ± Standard Deviation
  37.9  ± 12.2  
Gender  
[units: participants]
 
Female     52  
Male     120  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)   [ Time Frame: Endpoint (premature discontinuation or Week 52) ]

2.  Secondary:   Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52   [ Time Frame: Baseline, Week 4, 12, 28, 52 ]

3.  Secondary:   Percentage of Participants With Metabolic Syndrome (MS)   [ Time Frame: Baseline, Week 4, 12, 28, 52 ]

4.  Secondary:   Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52   [ Time Frame: Week 4, 12, 28, 52 ]

5.  Secondary:   Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS)   [ Time Frame: Baseline, Week 4, 12, 28, 52 ]

6.  Secondary:   Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52   [ Time Frame: Baseline, Week 4, 12, 28, 52 ]

7.  Secondary:   Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52   [ Time Frame: Baseline, Week 4, 12, 28, 52 ]

8.  Secondary:   Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52   [ Time Frame: Baseline, Week 4, 12, 28, 52 ]

9.  Secondary:   Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52   [ Time Frame: Baseline, Week 4, 12, 28, 52 ]

10.  Secondary:   Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52   [ Time Frame: Baseline, Week 4, 12, 28, 52 ]

11.  Secondary:   Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52   [ Time Frame: Baseline, Week 4, 12, 28, 52 ]

12.  Secondary:   Change From Baseline in Weight at Week 4,12, 28 and 52   [ Time Frame: Baseline, Week 4, 12, 28, 52 ]

13.  Secondary:   Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52   [ Time Frame: Baseline, Week 4, 12, 28, 52 ]

14.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52   [ Time Frame: Baseline, Week 4, 12, 28, 52 ]

15.  Secondary:   Change From Baseline in Insulin Level at Week 4, 12, 28 and 52   [ Time Frame: Baseline, Week 4, 12, 28, 52 ]

16.  Secondary:   Change From Baseline in the Physical Activity Index Score at Week 28 and 52   [ Time Frame: Baseline, Week 28, 52 ]

17.  Secondary:   Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52   [ Time Frame: Baseline, Week 4, 12, 28, 52 ]

18.  Secondary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52   [ Time Frame: Baseline, Week 12, 28, 52 ]

19.  Secondary:   Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52   [ Time Frame: Baseline, Week 12, 28, 52 ]

20.  Secondary:   Clinical Global Impression-Improvement (CGI-I) Scale Score   [ Time Frame: Endpoint (premature discontinuation or Week 52) ]

21.  Secondary:   Change From Baseline in Drug-Attitude Inventory–30-Item Scale (DAI-30) Score at Week 28 and 52   [ Time Frame: Baseline, Week 28, 52 ]

22.  Secondary:   Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52   [ Time Frame: Baseline, Week 28, 52 ]

23.  Secondary:   Change From Baseline in European Quality of Life (EuroQoL) – 5 Dimensions Index (EQ-I) Score at Week 28 and 52   [ Time Frame: Baseline, Week 28, 52 ]

24.  Secondary:   Changes From Baseline in European Quality of Life (EuroQoL) – 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52   [ Time Frame: Baseline, Week 28, 52 ]

25.  Secondary:   Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52   [ Time Frame: Baseline, Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52 ]


  Serious Adverse Events


  Other Adverse Events


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
The study was prematurely terminated by sponsor due to changes in organizational strategy and resources, not due to safety concerns.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00748566     History of Changes
Other Study ID Numbers: A1281173
Study First Received: September 5, 2008
Results First Received: April 29, 2013
Last Updated: April 29, 2013
Health Authority: Canada: Health Canada