26-week open-label extension study evaluating the safety and tolerability of flexible doses of oral ziprasidone in adolescent subjects with schizophrenia. - NA

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-005502-23-SE
• Date of registration: 19/12/2005
• Prospective Registration: Yes
• Primary sponsor: Pfizer AB
• Public title: 26-week open-label extension study evaluating the safety and tolerability of flexible doses of oral ziprasidone in adolescent subjects with schizophrenia. - NA
• Scientific title: 26-week open-label extension study evaluating the safety and tolerability of flexible doses of oral ziprasidone in adolescent subjects with schizophrenia. - NA
• Date of first enrolment: 04/05/2006
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005502-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1. The subject and the authorized legal representative must understand the nature of the study and be able to comply with protocol requirements. The representative must sign an Informed Consent Document and the subject must provide Written Assent.
2. The subjects must have received study medication in Study A1281134. In general, subjects should have completed at least 3 weeks of double-blind treatment before entering this open-label extension. However, subjects who have insufficient treatment response and have reached their maximum tolerated dose may enroll in the open-label extension as early as 1 week after the end of their titration.
3. In the investigator’s opinion, the subject must be likely to continue to benefit from antipsychotic therapy and must have been free from any clinically significant safety concerns during the preceding double-blind study (ie, in the opinion of the investigator, the benefits that the subject is likely to derive from continued participation must outweigh the risks).
4. Females of childbearing potential may be included provided that they are not pregnant, not nursing, and are practicing effective contraception and meet all of the following criteria:
a. Are instructed and agree to avoid pregnancy during the study.
b. Have a negative serum pregnancy test (ß-hCG) at the baseline visit.
c. Use one of the following birth control methods:
· an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g. Norplant), transdermal hormonal contraceptive (e.g. Ortho-Evra), or an injectable contraceptive (e.g. Depo-Provera) for at least one month prior to entering the study and will continue its use throughout the study; or
· a barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study; or
· abstinence during the preceding double-blind study and intention to abstain from sexual activity throughout this extension study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Subjects who experienced a serious adverse event considered related to study medication during the preceding double-blind trial.
2. Subjects who experienced cardiac arrhythmias, conduction abnormalities, or QTc prolongation (confirmed and persisting QTcF =460 msec or increase from baseline of QTcF = 60 msec) during the preceding study (subjects with an increase in QTcF of = 60 msec but with QTcF = 400 msec will be reviewed on a case-by-case basis by the sponsor for possible inclusion in the study).
3. Subjects requiring any medications not allowed by the Concomitant Medication Table (see “Concomitant Medications”, below).
4. Subjects who require treatment with drugs that are known to consistently prolong the QT interval (see Concomitant Medication Table).
5. Subjects with a rating of 7 on the single Suicidal Ideation item (item #13) from the CDRS-R, or who are otherwise judged by the investigator as being at imminent risk of suicide.
6. Subjects who are judged by the investigator as being at imminent risk of homicide during the study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Schizophrenia
MedDRA version: 8.0 Level: LLT Classification code 10039626

Intervention(s)

Trade Name: Zeldox
Product Name: Zeldox
Product Code: NA
Pharmaceutical Form: Capsule*
INN or Proposed INN: Ziprasidone Hydrochloride (approved INN)
CAS Number: 138982-67-9
Current Sponsor code: CP-88,059-1
Other descriptive name: (5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2Hindol-2-one)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Zeldox
Product Name: Zeldox
Product Code: NA
Pharmaceutical Form: Capsule*
INN or Proposed INN: Ziprasidone Hydrochloride (approved INN)
CAS Number: 138982-67-9
Current Sponsor code: CP-88,059-1
Other descriptive name: (5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2Hindol-2-one)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Zeldox
Product Name: Zeldox
Product Code: NA
Pharmaceutical Form: Capsule*
INN or Proposed INN: Ziprasidone Hydrochloride (approved INN)
CAS Number: 138982-67-9
Current Sponsor code: CP-88,059-1
Other descriptive name: (5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2Hindol-2-one)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Zeldox
Product Name: Zeldox
Product Code: NA
Pharmaceutical Form: Capsule*
INN or Proposed INN: Ziprasidone Hydrochloride (approved INN)
CAS Number: 138982-67-9
Current Sponsor code: CP-88,059-1
Other descriptive name: (5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2Hindol-2-one)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Capsule*
Route of administration o

Primary Outcome(s)

Main Objective: To assess the safety and tolerability of oral ziprasidone (40-80 mg BID) during long-term, open-label administration in adolescent subjects with schizophrenia.

Primary end point(s): long term safety

Secondary Objective:

Secondary ID(s)

A1281135