Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Ziprasidone

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final visit) or ZIP-NY-98035 and with QTc <= 500 msec. Exclusion Criteria: All other patients who do not fit the inclusion criteria as stated above.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A1

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)

CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.

Change From Baseline in CGI-I at End of Study (up to 5 Years)

CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Change from baseline is score at observation minus score at baseline.

Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)

CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assessed investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).

Change From Baseline in CGI-S at End of Study (up to 5 Years)

CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline.

Secondary Outcome Measures

Number of Participants With Scores on Patient Preference Scale (PPS)

Patient rated satisfaction scale with responses: Much better, I prefer this medication, Slightly better, About the same, Slightly worse, and Much worse, I much preferred my previous medication.

Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years)

DAI, a 10-item scale to assess how the attitude of schizophrenia patients toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicated a positive subjective response (compliant), whilst a negative score indicated non-compliance. Change: score at observation minus score at baseline.

Full Information

NCT ID

NCT00174447

First Posted

September 12, 2005

Last Updated

March 2, 2021

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00174447

Brief Title

Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031

Official Title

Open Extension Study Evaluating The Long Term Efficacy , Safety And Tolerability Of Oral Ziprasidone In The Treatment Of Patients Who Have Successfully Completed The Previous Ziprasidone Study A1281031

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

October 2001 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (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

Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Ziprasidone

Intervention Description

Dosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid

Primary Outcome Measure Information:

Title

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)

Description

CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.

Time Frame

Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]

Title

Change From Baseline in CGI-I at End of Study (up to 5 Years)

Description

CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Change from baseline is score at observation minus score at baseline.

Time Frame

Baseline, up to 5 years (End of Study [LOCF])

Title

Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)

Description

CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assessed investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).

Time Frame

Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]

Title

Change From Baseline in CGI-S at End of Study (up to 5 Years)

Description

CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline.

Time Frame

Baseline, up to 5 years (End of Study [LOCF])

Secondary Outcome Measure Information:

Title

Number of Participants With Scores on Patient Preference Scale (PPS)

Description

Patient rated satisfaction scale with responses: Much better, I prefer this medication, Slightly better, About the same, Slightly worse, and Much worse, I much preferred my previous medication.

Time Frame

Baseline, up to 5 years (End of Study)

Title

Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years)

Description

DAI, a 10-item scale to assess how the attitude of schizophrenia patients toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicated a positive subjective response (compliant), whilst a negative score indicated non-compliance. Change: score at observation minus score at baseline.

Time Frame

Baseline, up to 5 years (End of Study)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final visit) or ZIP-NY-98035 and with QTc <= 500 msec. Exclusion Criteria: All other patients who do not fit the inclusion criteria as stated above.

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

Avignon

ZIP/Postal Code

84000

Country

France

Facility Name

Pfizer Investigational Site

City

DOLE Saint YLIE

ZIP/Postal Code

39108

Country

France

Facility Name

Pfizer Investigational Site

City

Lievin

ZIP/Postal Code

62800

Country

France

Facility Name

Pfizer Investigational Site

City

LYON cedex

ZIP/Postal Code

69373

Country

France

Facility Name

Pfizer Investigational Site

City

Montfavet

ZIP/Postal Code

84143

Country

France

Facility Name

Pfizer Investigational Site

City

Orvault

ZIP/Postal Code

44700

Country

France

Facility Name

Pfizer Investigational Site

City

Rennes

ZIP/Postal Code

35000

Country

France

Facility Name

Pfizer Investigational Site

City

Saint Egreve Cedex

ZIP/Postal Code

38521

Country

France

Facility Name

Pfizer Investigational Site

City

Saint Remy

ZIP/Postal Code

70160

Country

France

Facility Name

Pfizer Investigational Site

City

Strasbourg

ZIP/Postal Code

67100

Country

France

Facility Name

Pfizer Investigational Site

City

TOULON cedex

ZIP/Postal Code

83056

Country

France

Facility Name

Pfizer Investigational Site

City

Toulouse

ZIP/Postal Code

31000

Country

France

Facility Name

Pfizer Investigational Site

City

Toulouse

ZIP/Postal Code

31200

Country

France

Facility Name

Pfizer Investigational Site

City

Versailles

ZIP/Postal Code

78000

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

21796719

Citation

Geier JL, Karayal ON, Lewis M, Camm JA, Keane M, Kremer CM, Kolluri S, Reynolds R, Eng S, Strom BL. Methodological challenges in the coding and adjudication of sudden deaths in a large simple trial with observational follow-up: the ziprasidone observational study of cardiac outcomes (ZODIAC). Pharmacoepidemiol Drug Saf. 2011 Nov;20(11):1192-8. doi: 10.1002/pds.2185. Epub 2011 Jul 27.

Results Reference

derived

PubMed Identifier

18312045

Citation

Strom BL, Faich GA, Reynolds RF, Eng SM, D'Agostino RB, Ruskin JN, Kane JM. The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC): design and baseline subject characteristics. J Clin Psychiatry. 2008 Jan;69(1):114-21. doi: 10.4088/jcp.v69n0115.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281060&StudyName=Extension%20Study%20of%20Patients%20Successfully%20Treated%20by%20Ziprasidone%20in%20Study%20A1281031%20

Description

To obtain contact information for a study center near you, click here.

Schizophrenia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial