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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00139737
First received: August 29, 2005
Last updated: August 2, 2010
Last verified: August 2010
  Purpose

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).


Condition Intervention Phase
Schizophrenia
Drug: Ziprasidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 72 months ] [ Designated as safety issue: Yes ]
    All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.


Enrollment: 344
Study Start Date: March 2002
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ziprasidone
    20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.
    Other Name: Geodon, Zeldox
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139737

  Hide Study Locations
Locations
Italy
Pfizer Investigational Site
Sora, Frosinone, Italy, 03039
Pfizer Investigational Site
Parma, PR, Italy, 43100
Pfizer Investigational Site
Acri, CS, Italy, 87041
Pfizer Investigational Site
Arezzo, Italy, 52100
Pfizer Investigational Site
Arona (No), Italy, 28041
Pfizer Investigational Site
Bassano del Grappa, Italy, 36061
Pfizer Investigational Site
Bisceglie (ba), Italy, 70052
Pfizer Investigational Site
Bologna, Italy, 40122
Pfizer Investigational Site
Bologna, Italy, 40100
Pfizer Investigational Site
Bolzano, Italy, 39100
Pfizer Investigational Site
Brindisi, Italy, 72100
Pfizer Investigational Site
Cagliari, Italy, 09100
Pfizer Investigational Site
Casalecchio Di Reno BO, Italy, 40033
Pfizer Investigational Site
Caserta, Italy, 81100
Pfizer Investigational Site
Catania, Italy, 95127
Pfizer Investigational Site
Cefalu' (Pa), Italy, 90015
Pfizer Investigational Site
Cesena FO, Italy, 47023
Pfizer Investigational Site
Chiari (Bs), Italy, 25032
Pfizer Investigational Site
Cremona, Italy, 26100
Pfizer Investigational Site
Crotone, Italy, 88900
Pfizer Investigational Site
Cuneo, Italy, 12100
Pfizer Investigational Site
Dolo (Ve), Italy, 30030
Pfizer Investigational Site
Empoli, Italy, 50053
Pfizer Investigational Site
Enna, Italy, 94100
Pfizer Investigational Site
Fano (PS), Italy, 61032
Pfizer Investigational Site
Formia (LT), Italy, 04023
Pfizer Investigational Site
Frattaminore (NA), Italy, 80020
Pfizer Investigational Site
Genova, Italy, 16165
Pfizer Investigational Site
Genova, Italy, 16149
Pfizer Investigational Site
Genova, Italy, 16132
Pfizer Investigational Site
Genzano (rm), Italy, 00045
Pfizer Investigational Site
Giarre, CT, Italy, 95014
Pfizer Investigational Site
Guardiagrele (ch), Italy, 66016
Pfizer Investigational Site
L'Aquila, Italy, 67100
Pfizer Investigational Site
Lamezia Terme, Italy, 88046
Pfizer Investigational Site
Lecce, Italy, 73100
Pfizer Investigational Site
Livorno, Italy, 57100
Pfizer Investigational Site
Matera, Italy, 75100
Pfizer Investigational Site
Melzo (MI), Italy, 26066
Pfizer Investigational Site
Merano (bz), Italy, 39012
Pfizer Investigational Site
Milano, Italy, 20100
Pfizer Investigational Site
Milano, Italy, 20122
Pfizer Investigational Site
Milano, Italy, 20142
Pfizer Investigational Site
Montebelluna (tv), Italy, 31044
Pfizer Investigational Site
Montecchio Maggiore (vi), Italy, 36075
Pfizer Investigational Site
Montevarchi (ar), Italy, 52025
Pfizer Investigational Site
Monza MI, Italy, 20052
Pfizer Investigational Site
Napoli, Italy, 80136
Pfizer Investigational Site
Nocera Inferiore, SA, Italy, 84014
Pfizer Investigational Site
Noto, Italy, 96017
Pfizer Investigational Site
Novi Ligure, AL, Italy
Pfizer Investigational Site
Orbassano, TO, Italy, 10043
Pfizer Investigational Site
Padova, Italy, 35128
Pfizer Investigational Site
Palermo, Italy, 90100
Pfizer Investigational Site
Palermo, Italy, 90127
Pfizer Investigational Site
Palermo, Italy, 90145
Pfizer Investigational Site
Partinico (Pa), Italy, 90047
Pfizer Investigational Site
Passirana Di Rho (Mi), Italy, 20017
Pfizer Investigational Site
Pavia, Italy, 27100
Pfizer Investigational Site
Perugia, Italy, 06127
Pfizer Investigational Site
Pisa, Italy, 56126
Pfizer Investigational Site
Pordenone, Italy, 33170
Pfizer Investigational Site
Portogruaro (Ve), Italy, 30026
Pfizer Investigational Site
Puglianello (BN), Italy, 82030
Pfizer Investigational Site
Ragusa, Italy, 97100
Pfizer Investigational Site
Reggio Calabria, Italy, 89100
Pfizer Investigational Site
Rivoli, TO, Italy, 10098
Pfizer Investigational Site
Roma, Italy, 00144
Pfizer Investigational Site
Roma, Italy, 00149
Pfizer Investigational Site
Roma, Italy, 00152
Pfizer Investigational Site
Roma, Italy, 00133
Pfizer Investigational Site
Salerno, Italy, 84100
Pfizer Investigational Site
San Benedetto del Tronto, AP, Italy, 63039
Pfizer Investigational Site
San Giorgio di Piano BO, Italy, 40016
Pfizer Investigational Site
San Marco In Lamis FG, Italy, 71014
Pfizer Investigational Site
Sant'Arsenio (SA), Italy, 84037
Pfizer Investigational Site
Sassari, Italy, 07100
Pfizer Investigational Site
Senigallia, AN, Italy, 60019
Pfizer Investigational Site
Spoleto (pg), Italy
Pfizer Investigational Site
Taranto, Italy, 74100
Pfizer Investigational Site
Tivoli (RM), Italy, 00019
Pfizer Investigational Site
Torino, Italy, 10147
Pfizer Investigational Site
Torino, Italy, 10154
Pfizer Investigational Site
Treviso, Italy, 31100
Pfizer Investigational Site
Udine, Italy, 33100
Pfizer Investigational Site
Verona, Italy, 37063
Pfizer Investigational Site
Viareggio, Italy, 55049
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00139737     History of Changes
Other Study ID Numbers: A1281061
Study First Received: August 29, 2005
Results First Received: June 15, 2010
Last Updated: August 2, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by Pfizer:
Open-label extension Ziprasidone study in Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Ziprasidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 20, 2014