Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031

NCT00174447 | Completed Phase 3 Results

• 1 other identifier: A1281060
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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.

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

• 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).

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

• 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.

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

Secondary Outcomes (2)

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

  Baseline, up to 5 years (End of Study)

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

  Baseline, up to 5 years (End of Study)

Study Arms (1)

A1

EXPERIMENTAL

Drug: Ziprasidone

Interventions

Ziprasidone DRUG

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

A1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final visit) or ZIP-NY-98035 and with QTc \<= 500 msec.

Sponsors & Collaborators

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

Study Sites (14)

Pfizer Investigational Site

Avignon, 84000, France

Location

Pfizer Investigational Site

DOLE Saint YLIE, 39108, France

Location

Pfizer Investigational Site

Liévin, 62800, France

Location

Pfizer Investigational Site

Lyon, 69373, France

Location

Pfizer Investigational Site

Montfavet, 84143, France

Location

Pfizer Investigational Site

Orvault, 44700, France

Location

Pfizer Investigational Site

Rennes, 35000, France

Location

Pfizer Investigational Site

Saint-Égrève, 38521, France

Location

Pfizer Investigational Site

Saint-Rémy, 70160, France

Location

Pfizer Investigational Site

Strasbourg, 67100, France

Location

Pfizer Investigational Site

Toulon, 83056, France

Location

Pfizer Investigational Site

Toulouse, 31000, France

Location

Pfizer Investigational Site

Toulouse, 31200, France

Location

Pfizer Investigational Site

Versailles, 78000, France

Location

Related Publications (2)

• 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.

  PMID: 21796719 DERIVED

• 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.

  PMID: 18312045 DERIVED

Related Links

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

MeSH Terms

Conditions

Schizophrenia

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

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: September 12, 2005
• First Posted: September 15, 2005
• Study Start: October 1, 2001
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 24, 2021
• Results First Posted: November 17, 2009

Record last verified: 2021-03

Locations

FR (14)