Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00174447
• Collaborator: (none)
• Enrollment: 43
• Locations: 14
• Arm: 1
• Duration (Months): 84
• Patients Per Site: 3.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Ziprasidone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Oct 1, 2001
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A1	Drug: Ziprasidone; 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

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) [Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]]

   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.

2. Change From Baseline in CGI-I at End of Study (up to 5 Years) [Baseline, up to 5 years (End of Study [LOCF])]

   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.

3. Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) [Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]]

   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).

4. Change From Baseline in CGI-S at End of Study (up to 5 Years) [Baseline, up to 5 years (End of Study [LOCF])]

   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

1. Number of Participants With Scores on Patient Preference Scale (PPS) [Baseline, up to 5 years (End of Study)]

   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.

2. Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years) [Baseline, up to 5 years (End of Study)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Avignon		France	84000
2	Pfizer Investigational Site	DOLE Saint YLIE		France	39108
3	Pfizer Investigational Site	Lievin		France	62800
4	Pfizer Investigational Site	LYON cedex		France	69373
5	Pfizer Investigational Site	Montfavet		France	84143
6	Pfizer Investigational Site	Orvault		France	44700
7	Pfizer Investigational Site	Rennes		France	35000
8	Pfizer Investigational Site	Saint Egreve Cedex		France	38521
9	Pfizer Investigational Site	Saint Remy		France	70160
10	Pfizer Investigational Site	Strasbourg		France	67100
11	Pfizer Investigational Site	TOULON cedex		France	83056
12	Pfizer Investigational Site	Toulouse		France	31000
13	Pfizer Investigational Site	Toulouse		France	31200
14	Pfizer Investigational Site	Versailles		France	78000

Sponsors and Collaborators

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

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00174447
• Other Study ID Numbers: A1281060
• First Posted: Sep 15, 2005
• Last Update Posted: Mar 24, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Schizophrenia; Ziprasidone

Study Results

Participant Flow

Arm/Group Title	Ziprasidone
Arm/Group Description	Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
Period Title: Overall Study
STARTED	43
COMPLETED	5
NOT COMPLETED	38

Baseline Characteristics

Arm/Group Title	Ziprasidone
Arm/Group Description	Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
Overall Participants	43
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.1 (13.3)
Sex: Female, Male (Count of Participants)
Female	23 53.5%
Male	20 46.5%

Outcome Measures

1. Primary Outcome

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]

Outcome Measure Data

Analysis Population Description

Intention to treat (ITT), all patients who received at least one dose of study medication and who have at least one post baseline efficacy evaluation. Imputation at Last Observation Carried Forward (LOCF).

Arm/Group Title	Ziprasidone
Arm/Group Description	Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
Measure Participants	43
Baseline (n=43): very much improved	13 30.2%
Baseline (n=43): much improved	30 69.8%
3 months (n=35): very much improved	10 23.3%
3 months (n=35): much improved	20 46.5%
3 months (n=35): minimally improved	2 4.7%
3 months (n=35): no change	3 7%
6 months (n=34): very much improved	11 25.6%
6 months (n=34): much improved	18 41.9%
6 months (n=34): minimally improved	2 4.7%
6 months (n=34): no change	2 4.7%
6 months (n=34): minimally worsened	1 2.3%
1 year (n=27): very much improved	7 16.3%
1 year (n=27): much improved	16 37.2%
1 year (n=27): minimally improved	1 2.3%
1 year (n=27): no change	3 7%
3 years (n=10): very much improved	2 4.7%
3 years (n=10): much improved	5 11.6%
3 years (n=10): no change	2 4.7%
3 years (n=10): minimally worsened	1 2.3%
5 years (n=7): very much improved	2 4.7%
5 years (n=7): much improved	4 9.3%
5 years (n=7): minimally improved	1 2.3%
End of Study [LOCF] (n=43): very much improved	5 11.6%
End of Study [LOCF] (n=43): much improved	17 39.5%
End of Study [LOCF] (n=43): minimally improved	5 11.6%
End of Study [LOCF] (n=43): no change	6 14%
End of Study [LOCF] (n=43): minimally worsened	4 9.3%
End of Study [LOCF] (n=43): much worsened	6 14%

2. Primary Outcome

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])

Outcome Measure Data

Analysis Population Description

ITT. LOCF.

Arm/Group Title	Ziprasidone
Arm/Group Description	Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
Measure Participants	43
Mean (Standard Deviation) [score on a scale]	1.4 (1.6)

3. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Ziprasidone
Arm/Group Description	Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
Measure Participants	43
Baseline (n=43): much better	28 65.1%
Baseline (n=43): slightly better	13 30.2%
Baseline (n=43): about the same	2 4.7%
End of study (n=28): much better	4 9.3%
End of study (n=28): slightly better	8 18.6%
End of study (n=28): about the same	8 18.6%
End of study (n=28): slightly worse	3 7%
End of study (n=28): much worse	5 11.6%

4. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

ITT. n= number of participants with analyzable data.

Arm/Group Title	Ziprasidone
Arm/Group Description	Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
Measure Participants	24
Mean (Standard Deviation) [score on a scale]	-3.3 (4.6)

5. Primary Outcome

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]

Outcome Measure Data

Analysis Population Description

ITT. LOCF.

Arm/Group Title	Ziprasidone
Arm/Group Description	Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
Measure Participants	43
Baseline (n=43): normal, not ill at all	4 9.3%
Baseline (n=43): borderline	20 46.5%
Baseline (n=43): mildly ill	14 32.6%
Baseline (n=43): moderately ill	4 9.3%
Baseline (n=43): markedly ill	1 2.3%
3 months (n=35): normal, not ill at all	6 14%
3 months (n=35): borderline	13 30.2%
3 months (n=35): mildly ill	10 23.3%
3 months (n=35): moderately ill	6 14%
6 months (n=34): normal, not ill at all	8 18.6%
6 months (n=34): borderline	10 23.3%
6 months (n=34): mildly ill	11 25.6%
6 months (n=34): moderately ill	5 11.6%
1 year (n=27): normal, not ill at all	6 14%
1 year (n=27): borderline	10 23.3%
1 year (n=27): mildly ill	9 20.9%
1 year (n=27): moderately ill	2 4.7%
3 years (n=10): normal, not ill at all	1 2.3%
3 years (n=10): borderline	5 11.6%
3 years (n=10): mildly ill	2 4.7%
3 years (n=10): moderately ill	2 4.7%
5 years (n=7): normal, not ill at all	1 2.3%
5 years (n=7): borderline	4 9.3%
5 years (n=7): mildly ill	2 4.7%
End of Study [LOCF] (n=43): normal, not ill at all	4 9.3%
End of Study [LOCF] (n=43): borderline	9 20.9%
End of Study [LOCF] (n=43): mildly ill	9 20.9%
End of Study [LOCF] (n=43): moderately ill	10 23.3%
End of Study [LOCF] (n=43):markedly ill	8 18.6%
End of Study [LOCF] (n=43): severely ill	3 7%

6. Primary Outcome

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])

Outcome Measure Data

Analysis Population Description

ITT. LOCF.

Arm/Group Title	Ziprasidone
Arm/Group Description	Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
Measure Participants	43
Mean (Standard Deviation) [score on a scale]	0.9 (1.5)

Adverse Events

Arm/Group Title	Ziprasidone
Arm/Group Description	Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
All Cause Mortality
	Ziprasidone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ziprasidone
	Affected / at Risk (%)	# Events
Total	13/43 (30.2%)
Gastrointestinal disorders
Faecal incontinence	1/43 (2.3%)
Metabolism and nutrition disorders
Type 2 diabetes mellitus	1/43 (2.3%)
Nervous system disorders
Memory impairment	1/43 (2.3%)
Psychiatric disorders
Schizophrenia	4/43 (9.3%)
Anxiety	2/43 (4.7%)
Depression	1/43 (2.3%)
Drug abuse	1/43 (2.3%)
Insomnia	1/43 (2.3%)
Panic attack	1/43 (2.3%)
Psychotic disorder	1/43 (2.3%)
Schizoaffective disorder	1/43 (2.3%)
Sleep disorder	1/43 (2.3%)
Renal and urinary disorders
Urinary incontinence	2/43 (4.7%)
Other (Not Including Serious) Adverse Events
	Ziprasidone
	Affected / at Risk (%)	# Events
Total	36/43 (83.7%)
Cardiac disorders
Tachycardia	1/43 (2.3%)
Ear and labyrinth disorders
Vertigo	3/43 (7%)
Deafness unilateral	1/43 (2.3%)
Eye disorders
Myopia	1/43 (2.3%)
Visual disturbance	1/43 (2.3%)
Gastrointestinal disorders
Nausea	3/43 (7%)
Diarrhoea	2/43 (4.7%)
Gastric ulcer	2/43 (4.7%)
Abdominal pain	1/43 (2.3%)
Abdominal pain upper	1/43 (2.3%)
Gastrooesophageal reflux disease	1/43 (2.3%)
Tongue disorder	1/43 (2.3%)
Vomiting	1/43 (2.3%)
General disorders
Asthenia	3/43 (7%)
Chest discomfort	1/43 (2.3%)
Infections and infestations
Influenza	2/43 (4.7%)
Nasopharyngitis	2/43 (4.7%)
Bronchitis	1/43 (2.3%)
Folliculitis	1/43 (2.3%)
Gastroenteritis	1/43 (2.3%)
Pharyngitis	1/43 (2.3%)
Injury, poisoning and procedural complications
Drug dispensing error	3/43 (7%)
Facial bones fracture	1/43 (2.3%)
Joint sprain	1/43 (2.3%)
Investigations
Weight decreased	5/43 (11.6%)
Weight increased	4/43 (9.3%)
Metabolism and nutrition disorders
Hypoglycaemic unconsciousness	1/43 (2.3%)
Iron deficiency	1/43 (2.3%)
Musculoskeletal and connective tissue disorders
Tendonitis	1/43 (2.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Langerhans' cell granulomatosis	1/43 (2.3%)
Nervous system disorders
Headache	4/43 (9.3%)
Extrapyramidal disorder	2/43 (4.7%)
Parkinsonism	2/43 (4.7%)
Sensory disturbance	2/43 (4.7%)
Akathisia	1/43 (2.3%)
Dyskinesia	1/43 (2.3%)
Somnolence	1/43 (2.3%)
Tremor	1/43 (2.3%)
Psychiatric disorders
Anxiety	10/43 (23.3%)
Schizophrenia	6/43 (14%)
Insomnia	7/43 (16.3%)
Depression	5/43 (11.6%)
Depressed mood	5/43 (11.6%)
Panic attack	2/43 (4.7%)
Sleep disorder	2/43 (4.7%)
Hallucination	2/43 (4.7%)
Schizoaffective disorder	1/43 (2.3%)
Abulia	1/43 (2.3%)
Alcoholism	1/43 (2.3%)
Libido decreased	1/43 (2.3%)
Libido increased	1/43 (2.3%)
Middle insomnia	1/43 (2.3%)
Psychomotor retardation	1/43 (2.3%)
Reactive psychosis	1/43 (2.3%)
Stress	1/43 (2.3%)
Reproductive system and breast disorders
Breast cyst	1/43 (2.3%)
Erectile dysfunction	1/43 (2.3%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/43 (2.3%)
Dyspnoea	1/43 (2.3%)
Skin and subcutaneous tissue disorders
Hyperhidrosis	1/43 (2.3%)
Vascular disorders
Hypotension	4/43 (9.3%)
Hot flush	1/43 (2.3%)
Hypertension	1/43 (2.3%)
Orthostatic hypotension	1/43 (2.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.