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Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Ziprasidone
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Open-label extension Ziprasidone study in Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects who have successfully completed a ziprasidone clinical study Patients not hospitalised in an acute psychiatric service Written, informed consent to participation. Female patients of at risk of pregnancy must avoid to remain pregnant; an adequate method of contraception (intrauterine device, implanted contraceptive, oral contraceptive or condom) must be initiated or continued Exclusion Criteria: Psychiatric: Subjects at immediate risk of committing harm to self or others Subjects requiring concurrent treatment with non-study antipsychotic agents Subjects requiring treatment with antidepressants or mood stabilizers General: Subjects with a history of clinically significant and/or currently relevant hematological, renal (including single kidney), hepatic, gastrointestinal, endocrine (except for current adequately treated hypo- or hyperthyroidism), pulmonary (excluding chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease), dermatological, oncological, or neurological disease, excluding tardive dyskinesia but including all forms of epilepsy (febrile convulsions in childhood acceptable). The only subjects with known prior malignant disease who are eligible are those with cured prior skin cancer (excluding melanoma). Controlled Type II diabetes (glucose < 180 mg/100 ml at screening and baseline with dietary or oral hypoglycemic treatment) will not be considered a significant medical illness and would not exclude a subject from the study Acute or chronic heart disease Clinically significant ECG abnormalities Subjects with QTc >= 500 msec (subjects with QTc >= 450 msec and < 500 msec should be discussed with the cardiologist who is responsible for all of the centers involved) Concomitant treatment with medications that prolong QTc interval (please review prescribing information of other treatments) Subjects with serum K+ or Mg++ outside the normal range Subject with any confirmed laboratory values that deviate from the upper or lower limits of normal prior to study entry, except for clinically insignificant deviations as determined by investigator Known serological evidence of HIV, or acute or chronic hepatitis (with transaminase levels higher than three times upper limit) Pregnant or lactating women Subjects who intend to donate blood or blood products during the 4 weeks prior to the study, during the study or in the 30 days after the study ends Subjects unable or unlikely to follow the study protocol Subjects with a history of neuroleptic malignant syndrome developing from the administration of antipsychotic compounds Known hypersensitivity to ziprasidone or lactose

Sites / Locations

  • Pfizer Investigational Site
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Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.

Secondary Outcome Measures

Full Information

First Posted
August 29, 2005
Last Updated
March 2, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00139737
Brief Title
Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia
Official Title
Open Extension Study Evaluating the Safety and Tolerability of Oral Ziprasidone in the Treatment of Subjects Who Have Successfully Completed a Previous Ziprasidone Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To provide treatment to eligible subjects who have successfully completed one of the following phase III ziprasidone studies, A1281028, A1281044, A1281045 (NCT00136994) or A1281088 (NCT00143351).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Open-label extension Ziprasidone study in Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
344 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Other Intervention Name(s)
Geodon, Zeldox
Intervention Description
20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.
Time Frame
Baseline up to 72 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who have successfully completed a ziprasidone clinical study Patients not hospitalised in an acute psychiatric service Written, informed consent to participation. Female patients of at risk of pregnancy must avoid to remain pregnant; an adequate method of contraception (intrauterine device, implanted contraceptive, oral contraceptive or condom) must be initiated or continued Exclusion Criteria: Psychiatric: Subjects at immediate risk of committing harm to self or others Subjects requiring concurrent treatment with non-study antipsychotic agents Subjects requiring treatment with antidepressants or mood stabilizers General: Subjects with a history of clinically significant and/or currently relevant hematological, renal (including single kidney), hepatic, gastrointestinal, endocrine (except for current adequately treated hypo- or hyperthyroidism), pulmonary (excluding chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease), dermatological, oncological, or neurological disease, excluding tardive dyskinesia but including all forms of epilepsy (febrile convulsions in childhood acceptable). The only subjects with known prior malignant disease who are eligible are those with cured prior skin cancer (excluding melanoma). Controlled Type II diabetes (glucose < 180 mg/100 ml at screening and baseline with dietary or oral hypoglycemic treatment) will not be considered a significant medical illness and would not exclude a subject from the study Acute or chronic heart disease Clinically significant ECG abnormalities Subjects with QTc >= 500 msec (subjects with QTc >= 450 msec and < 500 msec should be discussed with the cardiologist who is responsible for all of the centers involved) Concomitant treatment with medications that prolong QTc interval (please review prescribing information of other treatments) Subjects with serum K+ or Mg++ outside the normal range Subject with any confirmed laboratory values that deviate from the upper or lower limits of normal prior to study entry, except for clinically insignificant deviations as determined by investigator Known serological evidence of HIV, or acute or chronic hepatitis (with transaminase levels higher than three times upper limit) Pregnant or lactating women Subjects who intend to donate blood or blood products during the 4 weeks prior to the study, during the study or in the 30 days after the study ends Subjects unable or unlikely to follow the study protocol Subjects with a history of neuroleptic malignant syndrome developing from the administration of antipsychotic compounds Known hypersensitivity to ziprasidone or lactose
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Sora
State/Province
Frosinone
ZIP/Postal Code
03039
Country
Italy
Facility Name
Pfizer Investigational Site
City
Parma
State/Province
PR
ZIP/Postal Code
43100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Acri, CS
ZIP/Postal Code
87041
Country
Italy
Facility Name
Pfizer Investigational Site
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Arona (No)
ZIP/Postal Code
28041
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bassano del Grappa
ZIP/Postal Code
36061
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bisceglie (BA)
ZIP/Postal Code
70052
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40122
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bolzano
ZIP/Postal Code
39100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Brindisi
ZIP/Postal Code
72100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Cagliari
ZIP/Postal Code
09100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Casalecchio Di Reno BO
ZIP/Postal Code
40033
Country
Italy
Facility Name
Pfizer Investigational Site
City
Caserta
ZIP/Postal Code
81100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Catania
ZIP/Postal Code
95127
Country
Italy
Facility Name
Pfizer Investigational Site
City
Cefalu' (Pa)
ZIP/Postal Code
90015
Country
Italy
Facility Name
Pfizer Investigational Site
City
Cesena FO
ZIP/Postal Code
47023
Country
Italy
Facility Name
Pfizer Investigational Site
City
Chiari (Bs)
ZIP/Postal Code
25032
Country
Italy
Facility Name
Pfizer Investigational Site
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Crotone
ZIP/Postal Code
88900
Country
Italy
Facility Name
Pfizer Investigational Site
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Dolo (Ve)
ZIP/Postal Code
30030
Country
Italy
Facility Name
Pfizer Investigational Site
City
Empoli
ZIP/Postal Code
50053
Country
Italy
Facility Name
Pfizer Investigational Site
City
Enna
ZIP/Postal Code
94100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Fano (PS)
ZIP/Postal Code
61032
Country
Italy
Facility Name
Pfizer Investigational Site
City
Formia (LT)
ZIP/Postal Code
04023
Country
Italy
Facility Name
Pfizer Investigational Site
City
Frattaminore (NA)
ZIP/Postal Code
80020
Country
Italy
Facility Name
Pfizer Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Pfizer Investigational Site
City
Genova
ZIP/Postal Code
16149
Country
Italy
Facility Name
Pfizer Investigational Site
City
Genova
ZIP/Postal Code
16165
Country
Italy
Facility Name
Pfizer Investigational Site
City
Genzano (RM)
ZIP/Postal Code
00045
Country
Italy
Facility Name
Pfizer Investigational Site
City
Giarre, CT
ZIP/Postal Code
95014
Country
Italy
Facility Name
Pfizer Investigational Site
City
Guardiagrele (CH)
ZIP/Postal Code
66016
Country
Italy
Facility Name
Pfizer Investigational Site
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Lamezia Terme
ZIP/Postal Code
88046
Country
Italy
Facility Name
Pfizer Investigational Site
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Livorno
ZIP/Postal Code
57100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Matera
ZIP/Postal Code
75100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Melzo (MI)
ZIP/Postal Code
26066
Country
Italy
Facility Name
Pfizer Investigational Site
City
Merano (BZ)
ZIP/Postal Code
39012
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Pfizer Investigational Site
City
Montebelluna (TV)
ZIP/Postal Code
31044
Country
Italy
Facility Name
Pfizer Investigational Site
City
Montecchio Maggiore (VI)
ZIP/Postal Code
36075
Country
Italy
Facility Name
Pfizer Investigational Site
City
Montevarchi (AR)
ZIP/Postal Code
52025
Country
Italy
Facility Name
Pfizer Investigational Site
City
Monza MI
ZIP/Postal Code
20052
Country
Italy
Facility Name
Pfizer Investigational Site
City
Napoli
ZIP/Postal Code
80136
Country
Italy
Facility Name
Pfizer Investigational Site
City
Nocera Inferiore, SA
ZIP/Postal Code
84014
Country
Italy
Facility Name
Pfizer Investigational Site
City
Noto
ZIP/Postal Code
96017
Country
Italy
Facility Name
Pfizer Investigational Site
City
Novi Ligure, AL
Country
Italy
Facility Name
Pfizer Investigational Site
City
Orbassano, TO
ZIP/Postal Code
10043
Country
Italy
Facility Name
Pfizer Investigational Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Pfizer Investigational Site
City
Palermo
ZIP/Postal Code
90100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Pfizer Investigational Site
City
Palermo
ZIP/Postal Code
90145
Country
Italy
Facility Name
Pfizer Investigational Site
City
Partinico (Pa)
ZIP/Postal Code
90047
Country
Italy
Facility Name
Pfizer Investigational Site
City
Passirana Di Rho (Mi)
ZIP/Postal Code
20017
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Perugia
ZIP/Postal Code
06127
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Facility Name
Pfizer Investigational Site
City
Portogruaro (Ve)
ZIP/Postal Code
30026
Country
Italy
Facility Name
Pfizer Investigational Site
City
Puglianello (BN)
ZIP/Postal Code
82030
Country
Italy
Facility Name
Pfizer Investigational Site
City
Ragusa
ZIP/Postal Code
97100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Reggio Calabria
ZIP/Postal Code
89100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Rivoli, TO
ZIP/Postal Code
10098
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00149
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Pfizer Investigational Site
City
Salerno
ZIP/Postal Code
84100
Country
Italy
Facility Name
Pfizer Investigational Site
City
San Benedetto Del Tronto, AP
ZIP/Postal Code
63039
Country
Italy
Facility Name
Pfizer Investigational Site
City
San Giorgio Di Piano BO
ZIP/Postal Code
40016
Country
Italy
Facility Name
Pfizer Investigational Site
City
San Marco In Lamis FG
ZIP/Postal Code
71014
Country
Italy
Facility Name
Pfizer Investigational Site
City
Sant'Arsenio (SA)
ZIP/Postal Code
84037
Country
Italy
Facility Name
Pfizer Investigational Site
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Senigallia, AN
ZIP/Postal Code
60019
Country
Italy
Facility Name
Pfizer Investigational Site
City
Spoleto (PG)
Country
Italy
Facility Name
Pfizer Investigational Site
City
Taranto
ZIP/Postal Code
74100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Tivoli (RM)
ZIP/Postal Code
00019
Country
Italy
Facility Name
Pfizer Investigational Site
City
Torino
ZIP/Postal Code
10147
Country
Italy
Facility Name
Pfizer Investigational Site
City
Torino
ZIP/Postal Code
10154
Country
Italy
Facility Name
Pfizer Investigational Site
City
Treviso
ZIP/Postal Code
31100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Verona
ZIP/Postal Code
37063
Country
Italy
Facility Name
Pfizer Investigational Site
City
Viareggio
ZIP/Postal Code
55049
Country
Italy

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281061&StudyName=Extension%20Study%3A%20Evaluating%20the%20Safety%20of%20Oral%20Ziprasidone%20in%20the%20Treatment%20of%20Subjects%20with%20Schizophrenia
Description
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Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia

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