Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia
Open Extension Study Evaluating the Safety and Tolerability of Oral Ziprasidone in the Treatment of Subjects Who Have Successfully Completed a Previous Ziprasidone Study
1 other identifier
interventional
344
1 country
87
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started Mar 2002
Longer than P75 for phase_3 schizophrenia
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 29, 2005
CompletedFirst Posted
Study publicly available on registry
August 31, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
July 14, 2010
CompletedMarch 3, 2021
March 1, 2021
7.3 years
August 29, 2005
June 15, 2010
March 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline up to 72 months
Interventions
20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (87)
Pfizer Investigational Site
Sora, Frosinone, 03039, Italy
Pfizer Investigational Site
Parma, PR, 43100, Italy
Pfizer Investigational Site
Acri, CS, 87041, Italy
Pfizer Investigational Site
Arezzo, 52100, Italy
Pfizer Investigational Site
Arona (No), 28041, Italy
Pfizer Investigational Site
Bassano del Grappa, 36061, Italy
Pfizer Investigational Site
Bisceglie (BA), 70052, Italy
Pfizer Investigational Site
Bologna, 40100, Italy
Pfizer Investigational Site
Bologna, 40122, Italy
Pfizer Investigational Site
Bolzano, 39100, Italy
Pfizer Investigational Site
Brindisi, 72100, Italy
Pfizer Investigational Site
Cagliari, 09100, Italy
Pfizer Investigational Site
Casalecchio Di Reno BO, 40033, Italy
Pfizer Investigational Site
Caserta, 81100, Italy
Pfizer Investigational Site
Catania, 95127, Italy
Pfizer Investigational Site
Cefalu' (Pa), 90015, Italy
Pfizer Investigational Site
Cesena FO, 47023, Italy
Pfizer Investigational Site
Chiari (Bs), 25032, Italy
Pfizer Investigational Site
Cremona, 26100, Italy
Pfizer Investigational Site
Crotone, 88900, Italy
Pfizer Investigational Site
Cuneo, 12100, Italy
Pfizer Investigational Site
Dolo (Ve), 30030, Italy
Pfizer Investigational Site
Empoli, 50053, Italy
Pfizer Investigational Site
Enna, 94100, Italy
Pfizer Investigational Site
Fano (PS), 61032, Italy
Pfizer Investigational Site
Formia (LT), 04023, Italy
Pfizer Investigational Site
Frattaminore (NA), 80020, Italy
Pfizer Investigational Site
Genova, 16132, Italy
Pfizer Investigational Site
Genova, 16149, Italy
Pfizer Investigational Site
Genova, 16165, Italy
Pfizer Investigational Site
Genzano (RM), 00045, Italy
Pfizer Investigational Site
Giarre, CT, 95014, Italy
Pfizer Investigational Site
Guardiagrele (CH), 66016, Italy
Pfizer Investigational Site
Lamezia Terme, 88046, Italy
Pfizer Investigational Site
Lecce, 73100, Italy
Pfizer Investigational Site
Livorno, 57100, Italy
Pfizer Investigational Site
L’Aquila, 67100, Italy
Pfizer Investigational Site
Matera, 75100, Italy
Pfizer Investigational Site
Melzo (MI), 26066, Italy
Pfizer Investigational Site
Merano (BZ), 39012, Italy
Pfizer Investigational Site
Milan, 20100, Italy
Pfizer Investigational Site
Milan, 20122, Italy
Pfizer Investigational Site
Milan, 20142, Italy
Pfizer Investigational Site
Montebelluna (TV), 31044, Italy
Pfizer Investigational Site
Montecchio Maggiore (VI), 36075, Italy
Pfizer Investigational Site
Montevarchi (AR), 52025, Italy
Pfizer Investigational Site
Monza MI, 20052, Italy
Pfizer Investigational Site
Napoli, 80136, Italy
Pfizer Investigational Site
Nocera Inferiore, SA, 84014, Italy
Pfizer Investigational Site
Noto, 96017, Italy
Pfizer Investigational Site
Novi Ligure, AL, Italy
Pfizer Investigational Site
Orbassano, to, 10043, Italy
Pfizer Investigational Site
Padua, 35128, Italy
Pfizer Investigational Site
Palermo, 90100, Italy
Pfizer Investigational Site
Palermo, 90127, Italy
Pfizer Investigational Site
Palermo, 90145, Italy
Pfizer Investigational Site
Partinico (Pa), 90047, Italy
Pfizer Investigational Site
Passirana Di Rho (Mi), 20017, Italy
Pfizer Investigational Site
Pavia, 27100, Italy
Pfizer Investigational Site
Perugia, 06127, Italy
Pfizer Investigational Site
Pisa, 56126, Italy
Pfizer Investigational Site
Pordenone, 33170, Italy
Pfizer Investigational Site
Portogruaro (Ve), 30026, Italy
Pfizer Investigational Site
Puglianello (BN), 82030, Italy
Pfizer Investigational Site
Ragusa, 97100, Italy
Pfizer Investigational Site
Reggio Calabria, 89100, Italy
Pfizer Investigational Site
Rivoli, to, 10098, Italy
Pfizer Investigational Site
Roma, 00133, Italy
Pfizer Investigational Site
Roma, 00144, Italy
Pfizer Investigational Site
Roma, 00149, Italy
Pfizer Investigational Site
Roma, 00152, Italy
Pfizer Investigational Site
Salerno, 84100, Italy
Pfizer Investigational Site
San Benedetto Del Tronto, AP, 63039, Italy
Pfizer Investigational Site
San Giorgio Di Piano BO, 40016, Italy
Pfizer Investigational Site
San Marco in Lamis FG, 71014, Italy
Pfizer Investigational Site
Sant'Arsenio (SA), 84037, Italy
Pfizer Investigational Site
Sassari, 07100, Italy
Pfizer Investigational Site
Senigallia, AN, 60019, Italy
Pfizer Investigational Site
Spoleto (PG), Italy
Pfizer Investigational Site
Taranto, 74100, Italy
Pfizer Investigational Site
Tivoli (RM), 00019, Italy
Pfizer Investigational Site
Torino, 10147, Italy
Pfizer Investigational Site
Torino, 10154, Italy
Pfizer Investigational Site
Treviso, 31100, Italy
Pfizer Investigational Site
Udine, 33100, Italy
Pfizer Investigational Site
Verona, 37063, Italy
Pfizer Investigational Site
Viareggio, 55049, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2005
First Posted
August 31, 2005
Study Start
March 1, 2002
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
March 3, 2021
Results First Posted
July 14, 2010
Record last verified: 2021-03