Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2006-003475-13
    Sponsor's Protocol Code Number:A1281148
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-11-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGreece - EOF
    A.2EudraCT number2006-003475-13
    A.3Full title of the trial
    A SIXTEEN-WEEK, MULTI-CENTER, OPEN-LABEL STUDY EVALUATING THE SAFETY, TOLERABILITY, AND EFFICACY OF SWITCHING FROM QUETIAPINE TO ZIPRASIDONE IN SUBJECTS DIAGNOSED WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA1281148
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Hellas AE
    B.1.3.4CountryGreece
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name GEODON 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Hellas AE
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZiprasidone Hydrochloride
    D.3.9.1CAS number 146939-27-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name GEODON 60 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Hellas AE
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZiprasidone Hydrochloride
    D.3.9.1CAS number 146939-27-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Schizophrenia and Schizoaffective Disorder
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10039635
    E.1.2Term Schizophrenia schizoaffective
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate change in weight as a result of switching to ziprasidone, in subjects who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate the effect on additional safety parameters (glucose and lipid metabolism) and efficacy parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
    General Inclusion Criteria
    1. Males or females, between 18 and 55 years of age, at the time of consent
    2. Be a female who is not of child-bearing potential (i.e. surgically sterile or postmenopausal for at least one year), or be non-pregnant and be established on an acceptable method of birth control or be one who abstains from sex. Female subjects must meet all of the following criteria:
    a. Agree to avoid pregnancy during the study and
    b. Have a negative serum pregnancy test (β-HCG) at screening and
    c. Use one of the birth control methods listed below for the duration of the trial. Preferred methods of birth control include:
    • An oral contraceptive agent, implantable contraceptive (e.g., Norplant) or an injectable contraceptive (e.g., Depo Provera) for at least one month prior to entering the study or prior to having sexual relations during the study and will continue its use throughout the study, or
    • An intrauterine device, or
    • Partner has had a vasectomy at least 3 months prior to study start
    Also Allowed:
    • A double-barrier method of a diaphragm with spermicide, plus a latex condom, or
    • Agree to abstain from sex for the duration of the trial.
    Note: complete abstinence will be considered on a case-by-case basis, but must first be reviewed and approved by the Sponsor-designated physician
    3. Subjects must be capable of reading at or above a 6th grade level
    4. Subjects must be willing and able to comply with study treatments, scheduled visits, and laboratory tests.
    5. Prior to participation in any study procedures, subjects must provide informed consent which is signed, dated, and witnessed, indicating that they have been informed of all pertinent benefits and risks of study participation and study procedures.
    Psychiatric Inclusion Criteria
    6. Subjects must have a primary diagnosis of schizophrenia, any subtype (295.xx), or schizoaffective disorder as defined in DSM-IV-TR™
    7. Subjects must have been treated as outpatients with oral doses of quetiapine in the range of 150-750 mg/day for a minimum of three months; subjects in day hospitals and supervised living situations will be allowed to participate
    8. Subjects must have achieved only a partial response to treatment with quetiapine, or have experienced troublesome side effects (sedation, weight gain, etc.) attributed to treatment with quetiapine
    Medical Inclusion Criteria
    1. Subjects must have normal vital signs, physical examination, ECG, and laboratory findings except for minor deviations determined and documented to be clinically insignificant by the investigator or a sub-investigator who is a medical doctor.
    2. Subjects must have a urine drug screen negative for illicit drugs; at the discretion of the investigator, subjects positive for cannabinoids or benzodiazepines may be admitted upon sponsor approval.
    E.4Principal exclusion criteria
    General Exclusion Criteria
    1. Subjects who are unable to provide informed consent
    2. Subjects who have a history of repeated non-compliance with treatment
    3. Subjects with contraindications according to the local prescribing information of Ziprasidone
    Psychiatric Exclusion Criteria
    1. Subjects who meet criteria for a DSM-IV-TR™ Axis I diagnosis other than schizophrenia or schizoaffective disorder, including psychoactive substance abuse or dependence within one year of study entry
    2. Subjects who are known to have ingested phencyclidine within 60 days of study entry
    3. Subjects who have been treated with antiepileptic drugs such as valproate, diphenylhydantoin, or carbamazepine within 30 days of study entry, even if used for augmentation of antipsychotic drugs
    4. Subjects who have been treated within 30 days of study entry with any psychoactive medication other than quetiapine, p.r.n. benzodiazepine, p.r.n. diphenhydramine, p.r.n. hypnotic, or antiparkinsonian medication (benztropine, trihexiphenidyl, or amantadine)
    5. Subjects with a history of suicide attempt who develop significant depression, acute suicidal ideation, or who attempt suicide during the study, will be discontinued from the study and provided with treatment (or an appropriate referral) by the investigator.
    6. Subjects judged by the investigator based on history, mental status exam, or investigator judgment as being at significant risk of self-injurious/suicidal or violent/homicidal behavior
    7. Subjects with a history of treatment resistance, defined as the presence of severe symptoms despite adequate trials with more than two other typical or atypical antipsychotics. Subjects who have failed to respond to quetiapine, or those who discontinued treatment primarily as a result of being unable to tolerate side effects (e.g., having seizures, agranulocytosis, excessive weight gain) may be included.
    8. Subjects who are receiving quetiapine at a dose of less than 150 mg/day, or any dose for less than 3 months.
    9. Subjects who have received depot antipsychotic medication within 30 days of enrollment. Subjects that received depot neuroleptic treatment may be included as long as the subject terminated treatment with the depot antipsychotic medication and has been treated with quetiapine for at least 3 months prior to Screening.
    10. Subjects who have ever been discontinued from ziprasidone treatment due to lack of efficacy or significant adverse event(s).
    Medical Exclusion Criteria
    1. Females who are pregnant, breast feeding, or lactating at screening.
    2. Females of childbearing potential who are unwilling or unable to use adequate contraception to prevent pregnancy during the program.
    3. Subjects who have a history of chronic hepatitis
    4. Subjects with a known history of Acquired Immune Deficiency Syndrome (AIDS), or who have previously tested seropositive for human immunodeficiency virus (HIV) antibody or antigen.
    5. Subjects who have used any other investigational drug for 3 months preceding or at any time during the study
    6. Subjects who have used, or are schedule to receive, any concomitant medications not allowed by the Concomitant Medication Table
    7. Subjects with any medical condition, medication, or dietary habit that may confound the evaluation of the study drug
    8. Subjects with any unstable or untreated medical illness.
    9. Subjects who have a medical condition that would interfere with assessments of efficacy or safety, or expose them to an increased risk of significant adverse events, including but not limited to cardiovascular, neurologic, endocrine, hepatic, respiratory, renal, or hematologic disease per investigator judgment.
    10. Subjects with a history of seizures (except febrile seizures of childhood), epilepsy, or a history of a clinically significant EEG.
    11. Subjects with thyroid pathology, or any thyroid hormone test abnormality (including but not limited to hypothyroidism or hyperthyroidism), unless the subject has been stabilized on medications for the past 3 months. The entry into the study of subjects who have minor thyroid hormone test abnormalities must first be discussed with the Sponsor-designated physician.
    12. Subjects with a QTc interval >500 msec (Bazett correction) at the screening or baseline visit; or subjects with a known history of prolongation of QTc interval (including congenital long QT syndrome), acute myocardial infarction (within the past six months), or uncompensated heart failure.
    13. Subjects with bradycardia, hypokalemia, hypomagnesemia, or concomitant use of other QTc prolonging drugs, or any other circumstance that could contribute to QTc prolongation.
    14. Subjects with a history of mild, moderate, or severe hepatic insufficiency.
    (15-18 excluded due to size limitation)
    E.5 End points
    E.5.1Primary end point(s)
    Unless otherwise specified, endpoints are calculated as the change in a parameter between Baseline and Week 16.
    The primary endpoint of the study is the change in weight (kg) at Week 16.
    Secondary safety endpoints consist of the following:
    • Fasting lipid profile (total cholesterol)
    • HDL, LDL and Triglycerides
    • Hb A1c
    • Fasting glucose and insulin
    • Waist and hip circumference
    • Abnormal Involuntary Movement Scale (AIMS)
    • Spontaneously reported adverse events during the study
    • Subjects reporting any adverse event during the study
    • Subjects reporting a mild, moderate, or severe adverse event during the study
    • Subjects discontinuing due to an adverse event during the study
    • Subjects who develop clinically significant abnormalities in blood chemistries, hematologies, or ECG parameters during the study
    Secondary efficacy endpoints consist of the following:
    • Positive and Negative Symptoms of Schizophrenia (PANSS) total score and
    positive and negative subscale scores
    • Clinical Global Impression, Improvement Scale (CGI-I) change from Clinical Global
    Impression, Severity Scale (CGI-S)
    • Calgary Depression Scale for Schizophrenia (CDSS)
    • Schizophrenia Cognition Rating Scale (SCoRS)
    • Global Assessment of Function Scale (GAF)
    • Treatment Satisfaction Questionnaire for Medication (TQSM)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of Trial is defined as the time at which it is deemed that sufficient subjects have been recruited and completed the trial as stated in the regulatory application. Poor recruitment (recruiting less than the anticipated number in the CTA) by a Member State is not a reason for premature termination but is considered a normal conclusion to the trial in that Member State.
    End of Trial in all participating countries is defined as Last Subject Last Visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 250
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-31
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 04:15:22 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA