One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01113541
Collaborator
(none)
13
10
1
7.1
1.3
0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to explore the impact of Ziprasidone HCl on the distribution of metabolic syndrome (MS) risk factors in a population of Bipolar patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ziprasidone HCL (oral)
Phase 3

Detailed Description

The trial was terminated prematurely on December 14, 2010, due to inability to recruit the planned number of subjects and shifting organizational priorities. The decision to terminate the trial was not based on any safety or efficacy concerns.

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A One-year, Phase III, Open-label, Non-comparative Trial of the Effect of Ziprasidone HCl on Metabolic Syndrome Risk Factors in Patients With Bipolar Disorder
Study Start Date :
Jul 1, 2010
Actual Primary Completion Date :
Feb 1, 2011
Actual Study Completion Date :
Feb 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active treatment (switch to oral Ziprasidone)

Drug: Ziprasidone HCL (oral)
Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40-160 mg total daily dose) for up to 1 year.
Other Names:
  • Zeldox, Geodon
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Who Achieved a Reduction From Baseline of at Least 1 Risk Factor for Metabolic Syndrome (MS) at Week 52 or Premature Discontinuation [Week 52 or Early Termination]

      MS risks factors: elevated (el) waist circumference: ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); el triglycerides: ≥1.7 millimoles per liter (mmol/L) (1≥50 milligrams per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; el fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and el systolic/diastolic blood pressure: systolic ≥130 millimeters of mercury (mmHg) and/or diastolic ≥85 mmHg. Responder = at least 1 less risk factor at endpoint than baseline.

    Secondary Outcome Measures

    1. Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) [Baseline, Week 52]

      MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.

    2. Metabolic Syndrome (MS) Prevalence [Baseline through Week 52]

      Percentage of participants at each visit defined as having metabolic syndrome (MS) based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel III. MS = 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.

    3. Change From Baseline in the Percentage of Participants With Each Individual Metabolic Syndrome (MS) Risk Factor [Baseline through Week 52]

      MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.

    4. Percentage of Participants With Individual Metabolic Syndrome (MS) Risk Factors [Baseline through Week 52]

      MS risks factors = elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.

    5. Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Waist Circumference [Baseline, Week 4, Week 12, Week 52]

      MS risk factor elevated waist circumference defined as ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]).

    6. Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Systolic/Diastolic Blood Pressure [Baseline, Week 4, Week 12, Week 52]

      MS risk factor elevated systolic/diastolic blood pressure defined as systolic blood pressure ≥130 millimeters of mercury (mm Hg) and/or diastolic blood pressure ≥85 mm Hg.

    7. Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Fasting Glucose [Baseline, Week 4, Week 12, Week 52]

      MS risk factor elevated fasting glucose defined as ≥5.6 millimoles per liter (mmol/L) (≥100 mg/dL).

    8. Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Reduced High-density Lipoprotein Cholesterol (HDL-C) [Baseline, Week 4, Week 12, Week 52]

      MS risk factor reduced HDL-C defined as <1.03 millimoles per liter (mmol/L) (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women.

    9. Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Triglycerides [Baseline, Week 4, Week 12, Week 52]

      MS risk factor elevated triglycerides defined as ≥1.7 millimoles per liter (mmol/L) (1≥50 mg/dL).

    10. Change From Baseline in Ten-year Coronary Heart Disease (CHD) Risk According to Framingham Scoring System [Baseline, Week 4, Week 52]

      Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range <0 to ≥25, higher score indicates higher 10 year risk (range <1% to ≥30% 10 year risk).

    11. Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels [Baseline, Week 52 or Early Termination]

    12. Change From Baseline in Weight [Baseline, Week 4, Week 12, Week 52 or Early Termination]

    13. Change From Baseline in Body Mass Index (BMI) [Baseline, Week 4, Week 12, Week 52 or Early Termination]

      Body mass index = weight in kilograms (kg) / height in meters (m)^2 .

    14. Change From Baseline in Glycosylated Hemoglobin (HbA1c) [Baseline, Week 52 or Early Termination]

    15. Change From Baseline in Insulin Levels [Baseline, Week 52 or Early Termination]

    16. Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF) [Baseline, Week 4, Week 52 or Early Termination]

      QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds.

    17. Change From Baseline in Apolipoprotein B (ApoB) Levels [Baseline, Week 52 or Early Termination]

    18. Change From Baseline in Leptin [Baseline, Week 52 or Early Termination]

    19. Change From Baseline in Physical Activity Index [Baseline, Week 28, Week 52 or Early Termination]

      Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (≥21). Higher score = higher frequency and intensity of physical activity.

    20. Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score [Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination]

      Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).

    21. Change From Baseline in Young Mania Rating Scale (YMRS) [Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination]

      11-item scale that measures the severity of manic episodes from subject reported symptoms over previous 48 hours and clinical observation during interview. Four items (irritability, speech, thought content, disruptive-aggressive behaviour) are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining 7 items (elevated mood, increased motor activity-energy, sexual interest, sleep, language-thought disorder, appearance, insight) are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). YMRS total score range = 0 to 60.

    22. Change From Baseline in Clinical Global Impression - Severity (CGI-S) Subscale [Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination]

      CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.

    23. Clinical Global Impression - Improvement (CGI-I) Subscale Score [Week 52 or Early Termination]

      CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.

    24. Change From Baseline in Drug Attitude Inventory (DAI) [Week 28, Week 52 or Early Termination]

      DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline.

    25. Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) [Baseline, Week 28, Week 52 or Early Termination]

      0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning. 1 to 10 = persistent inability to maintain minimal personal hygiene; unable to function without harming self or others or without considerable external support; 91 to 100 = superior functioning in a wide range of activities.

    26. Change From Baseline in EuroQoL Index (EQ-I) [Baseline, Week 28, Week 52 or Early Termination]

      EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    27. Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score [Baseline, Week 28, Week 52 or Early Termination]

      EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.

    28. Change From Baseline in Impact of Weight on Quality of Life-Lite Version (IWQOL-Lite) Scale [Baseline, Week 28, Week 52 or Early Termination]

      31-item self report inventory to assess impact of weight on quality of life. Five subscales: physical functioning, self-esteem, sexual life, public distress, and work, with categories in each subscale scored 1 (no trouble or difficulty) to 5 (persistent trouble or difficulty). The rescaled IWQoL-Lite score is determined by the sum of scores on all 31 items and rescaling this sum to a 1 to 100 scoring with 0=the poorest and 100=the best quality of life.

    29. Number of Participants With Suicidal Tendencies (Columbian-Suicide Severity Rating Scale, [C-SSRS], Mapped to C-CASA [Columbia Classification Algorithm For Suicide Assessment]) [Baseline, Week 1 through Week 52 or Early Termination]

      C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subject must present at least 2 of the following risk factors of MS at screening: Elevated waist circumference: >102 cm in men and >88 cm in women; Elevated triglycerides (TGs): ≥1.7 mmol/L (≥150 mg/dL); Reduced HDL-Cholesterol: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; Elevated fasting glucose: ≥ 5.6 mmol/L.

    • According to the clinical judgment of the investigator, the risk factors for MS have developed in close temporal relationship to starting an antipsychotic medication.

    • Substitution to a less metabolically disruptive antipsychotic medication is considered

    Exclusion Criteria:
    • Subjects with contraindication(s) to the use of Ziprasidone according to Canadian prescribing information.

    • Subjects with a history of treatment resistance.

    • Subjects with any medical condition (e.g. pre-existing diabetes, pre-existing dyslipidemia, thyroid pathology) or taking any concomitant medication (e.g. topiramate or other weight loss-promoting agents, hypoglycemic agents, hypolipemic agents), that may confound the evaluation of the study drug.

    • Body mass index ≥ 40 at baseline.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Foothills Medical Centre, Department of Psychiatry Calgary Alberta Canada T2N 2T9
    2 Mental Health Centre for Research and Education Calgary Alberta Canada T2N 2T9
    3 Dr. Alexander McIntyre Inc. Penticton British Columbia Canada V2A 4M4
    4 Country Club Plaza Winnipeg Manitoba Canada R3K 2E2
    5 Edgeland Medical, Dr. Alla Kirshner Medical Corporation Winnipeg Manitoba Canada R3P 0N5
    6 Capital, Health Authority, QE II Health Sciences Centre, Mood Disorder Clinic Halifax Nova Scotia Canada B3H 2E2
    7 Office of Dr. A. K. Munshi Sydney Nova Scotia Canada B1S 2E8
    8 Centre de recherche Fernand-Seguin de l'hopital Louis H. Lafontaine Montreal Quebec Canada H1N 3V2
    9 Clinique St-Leonard Montreal Quebec Canada H1P 3K2
    10 Diex Research Sherbrooke Inc. Sherbrooke Quebec Canada J1H 1Z1

    Sponsors and Collaborators

    • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
    ClinicalTrials.gov Identifier:
    NCT01113541
    Other Study ID Numbers:
    • A1281190
    First Posted:
    Apr 30, 2010
    Last Update Posted:
    Mar 3, 2021
    Last Verified:
    Mar 1, 2021
    Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Twenty-seven participants were screened for the study and 13 participants were assigned to study drug and treated.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Period Title: Overall Study
    STARTED 13
    COMPLETED 0
    NOT COMPLETED 13

    Baseline Characteristics

    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Overall Participants 13
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    46.5
    (10.7)
    Sex: Female, Male (Count of Participants)
    Female
    9
    69.2%
    Male
    4
    30.8%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Who Achieved a Reduction From Baseline of at Least 1 Risk Factor for Metabolic Syndrome (MS) at Week 52 or Premature Discontinuation
    Description MS risks factors: elevated (el) waist circumference: ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); el triglycerides: ≥1.7 millimoles per liter (mmol/L) (1≥50 milligrams per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; el fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and el systolic/diastolic blood pressure: systolic ≥130 millimeters of mercury (mmHg) and/or diastolic ≥85 mmHg. Responder = at least 1 less risk factor at endpoint than baseline.
    Time Frame Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    Per protocol population: all subjects in the intent-to-treat population who remained in the study for at least 28 weeks. N = number of participants with analyzable data at observation.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 10
    Number [percentage of participants]
    50.00
    384.6%
    2. Secondary Outcome
    Title Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS)
    Description MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    PP and Intent-to-treat (ITT) population; ITT population = all participants enrolled in the study who received at least 1 dose of study medication and who had baseline and at least 1 post-baseline MS measurement. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    3. Secondary Outcome
    Title Metabolic Syndrome (MS) Prevalence
    Description Percentage of participants at each visit defined as having metabolic syndrome (MS) based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel III. MS = 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.
    Time Frame Baseline through Week 52

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    4. Secondary Outcome
    Title Change From Baseline in the Percentage of Participants With Each Individual Metabolic Syndrome (MS) Risk Factor
    Description MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.
    Time Frame Baseline through Week 52

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    5. Secondary Outcome
    Title Percentage of Participants With Individual Metabolic Syndrome (MS) Risk Factors
    Description MS risks factors = elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.
    Time Frame Baseline through Week 52

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    6. Secondary Outcome
    Title Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Waist Circumference
    Description MS risk factor elevated waist circumference defined as ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]).
    Time Frame Baseline, Week 4, Week 12, Week 52

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    7. Secondary Outcome
    Title Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Systolic/Diastolic Blood Pressure
    Description MS risk factor elevated systolic/diastolic blood pressure defined as systolic blood pressure ≥130 millimeters of mercury (mm Hg) and/or diastolic blood pressure ≥85 mm Hg.
    Time Frame Baseline, Week 4, Week 12, Week 52

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    8. Secondary Outcome
    Title Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Fasting Glucose
    Description MS risk factor elevated fasting glucose defined as ≥5.6 millimoles per liter (mmol/L) (≥100 mg/dL).
    Time Frame Baseline, Week 4, Week 12, Week 52

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    9. Secondary Outcome
    Title Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Reduced High-density Lipoprotein Cholesterol (HDL-C)
    Description MS risk factor reduced HDL-C defined as <1.03 millimoles per liter (mmol/L) (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women.
    Time Frame Baseline, Week 4, Week 12, Week 52

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    10. Secondary Outcome
    Title Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Triglycerides
    Description MS risk factor elevated triglycerides defined as ≥1.7 millimoles per liter (mmol/L) (1≥50 mg/dL).
    Time Frame Baseline, Week 4, Week 12, Week 52

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    11. Secondary Outcome
    Title Change From Baseline in Ten-year Coronary Heart Disease (CHD) Risk According to Framingham Scoring System
    Description Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range <0 to ≥25, higher score indicates higher 10 year risk (range <1% to ≥30% 10 year risk).
    Time Frame Baseline, Week 4, Week 52

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    12. Secondary Outcome
    Title Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels
    Description
    Time Frame Baseline, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Median was reported due to small sample size and risk of skewing.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 10
    Total cholesterol: Baseline
    206.0
    Total cholesterol: Change at Last Observation
    -20.0
    LDL cholesterol: Baseline
    131.0
    LDL cholesterol: Change at Last Observation
    -8.0
    13. Secondary Outcome
    Title Change From Baseline in Weight
    Description
    Time Frame Baseline, Week 4, Week 12, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT; n = number of participants with evaluable data at observation.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 13
    Baseline (n=13)
    93.5
    (23.12)
    Value at Week 4 (n=9)
    92.9
    (21.99)
    Value at Week 12 (n=5)
    97.3
    (25.37)
    Value at Week 52 (n=10)
    87.5
    (24.50)
    14. Secondary Outcome
    Title Change From Baseline in Body Mass Index (BMI)
    Description Body mass index = weight in kilograms (kg) / height in meters (m)^2 .
    Time Frame Baseline, Week 4, Week 12, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results for BMI not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    15. Secondary Outcome
    Title Change From Baseline in Glycosylated Hemoglobin (HbA1c)
    Description
    Time Frame Baseline, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Median was reported due to small sample size and risk of skewing. Last observation = last observation while on study drug or during the lag.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 10
    Baseline
    5.5
    Median change
    -0.2
    16. Secondary Outcome
    Title Change From Baseline in Insulin Levels
    Description
    Time Frame Baseline, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Insulin levels not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    17. Secondary Outcome
    Title Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF)
    Description QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds.
    Time Frame Baseline, Week 4, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT; n = number of participants with analyzable data at observation.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 13
    Baseline (n=13)
    421.0
    (12.16)
    Week 4 (n=9)
    434.0
    (13.61)
    Week 52 or or Early Termination (n=9)
    428.8
    (14.65)
    18. Secondary Outcome
    Title Change From Baseline in Apolipoprotein B (ApoB) Levels
    Description
    Time Frame Baseline, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    19. Secondary Outcome
    Title Change From Baseline in Leptin
    Description
    Time Frame Baseline, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    20. Secondary Outcome
    Title Change From Baseline in Physical Activity Index
    Description Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (≥21). Higher score = higher frequency and intensity of physical activity.
    Time Frame Baseline, Week 28, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    21. Secondary Outcome
    Title Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score
    Description Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
    Time Frame Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    22. Secondary Outcome
    Title Change From Baseline in Young Mania Rating Scale (YMRS)
    Description 11-item scale that measures the severity of manic episodes from subject reported symptoms over previous 48 hours and clinical observation during interview. Four items (irritability, speech, thought content, disruptive-aggressive behaviour) are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining 7 items (elevated mood, increased motor activity-energy, sexual interest, sleep, language-thought disorder, appearance, insight) are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). YMRS total score range = 0 to 60.
    Time Frame Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    23. Secondary Outcome
    Title Change From Baseline in Clinical Global Impression - Severity (CGI-S) Subscale
    Description CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
    Time Frame Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    24. Secondary Outcome
    Title Clinical Global Impression - Improvement (CGI-I) Subscale Score
    Description CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
    Time Frame Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    25. Secondary Outcome
    Title Change From Baseline in Drug Attitude Inventory (DAI)
    Description DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline.
    Time Frame Week 28, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    26. Secondary Outcome
    Title Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS)
    Description 0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning. 1 to 10 = persistent inability to maintain minimal personal hygiene; unable to function without harming self or others or without considerable external support; 91 to 100 = superior functioning in a wide range of activities.
    Time Frame Baseline, Week 28, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    27. Secondary Outcome
    Title Change From Baseline in EuroQoL Index (EQ-I)
    Description EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
    Time Frame Baseline, Week 28, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    28. Secondary Outcome
    Title Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score
    Description EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
    Time Frame Baseline, Week 28, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    29. Secondary Outcome
    Title Change From Baseline in Impact of Weight on Quality of Life-Lite Version (IWQOL-Lite) Scale
    Description 31-item self report inventory to assess impact of weight on quality of life. Five subscales: physical functioning, self-esteem, sexual life, public distress, and work, with categories in each subscale scored 1 (no trouble or difficulty) to 5 (persistent trouble or difficulty). The rescaled IWQoL-Lite score is determined by the sum of scores on all 31 items and rescaling this sum to a 1 to 100 scoring with 0=the poorest and 100=the best quality of life.
    Time Frame Baseline, Week 28, Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0
    30. Secondary Outcome
    Title Number of Participants With Suicidal Tendencies (Columbian-Suicide Severity Rating Scale, [C-SSRS], Mapped to C-CASA [Columbia Classification Algorithm For Suicide Assessment])
    Description C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.
    Time Frame Baseline, Week 1 through Week 52 or Early Termination

    Outcome Measure Data

    Analysis Population Description
    PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    Measure Participants 0

    Adverse Events

    Time Frame
    Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Arm/Group Title Ziprasidone
    Arm/Group Description Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
    All Cause Mortality
    Ziprasidone
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Ziprasidone
    Affected / at Risk (%) # Events
    Total 1/13 (7.7%)
    Nervous system disorders
    Akathisia 1/13 (7.7%)
    Other (Not Including Serious) Adverse Events
    Ziprasidone
    Affected / at Risk (%) # Events
    Total 13/13 (100%)
    Ear and labyrinth disorders
    Vertigo 1/13 (7.7%)
    Gastrointestinal disorders
    Constipation 1/13 (7.7%)
    Nausea 5/13 (38.5%)
    General disorders
    Non-cardiac chest pain 1/13 (7.7%)
    Thirst 1/13 (7.7%)
    Infections and infestations
    Upper respiratory infection 1/13 (7.7%)
    Injury, poisoning and procedural complications
    Contusion 1/13 (7.7%)
    Investigations
    Blood cholesterol increased 1/13 (7.7%)
    Blood prolactin increased 1/13 (7.7%)
    High density lipoprotein decreased 1/13 (7.7%)
    Low density lipoprotein increased 1/13 (7.7%)
    Protein urine present 1/13 (7.7%)
    Musculoskeletal and connective tissue disorders
    Back pain 1/13 (7.7%)
    Neck pain 1/13 (7.7%)
    Pain in jaw 1/13 (7.7%)
    Nervous system disorders
    Akathisia 3/13 (23.1%)
    Disturbance in attention 1/13 (7.7%)
    Dizziness 2/13 (15.4%)
    Headache 5/13 (38.5%)
    Memory impairment 1/13 (7.7%)
    Sedation 1/13 (7.7%)
    Somnolence 4/13 (30.8%)
    Tension headache 1/13 (7.7%)
    Psychiatric disorders
    Agitation 2/13 (15.4%)
    Confusional state 1/13 (7.7%)
    Depression 2/13 (15.4%)
    Emotional disorder 1/13 (7.7%)
    Flat affect 1/13 (7.7%)
    Hypomania 1/13 (7.7%)
    Insomnia 6/13 (46.2%)
    Mania 1/13 (7.7%)
    Suicidal ideation 1/13 (7.7%)
    Terminal insomnia 1/13 (7.7%)
    Reproductive system and breast disorders
    Menstruation irregular 1/13 (7.7%)
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhea 1/13 (7.7%)
    Wheezing 1/13 (7.7%)
    Skin and subcutaneous tissue disorders
    Rash 1/13 (7.7%)
    Vascular disorders
    Hypertension 1/13 (7.7%)

    Limitations/Caveats

    This study was terminated due to slow enrollment and changes in organizational strategy and resources; most of the planned analyses in the statistical analysis plan were not performed.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer, Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
    ClinicalTrials.gov Identifier:
    NCT01113541
    Other Study ID Numbers:
    • A1281190
    First Posted:
    Apr 30, 2010
    Last Update Posted:
    Mar 3, 2021
    Last Verified:
    Mar 1, 2021