Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00139737
• Collaborator: (none)
• Enrollment: 344
• Locations: 87
• Duration (Months): 87
• Patients Per Site: 4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

To provide treatment to eligible subjects who have successfully completed one of the following phase III ziprasidone studies, A1281028, A1281044, A1281045 (NCT00136994) or A1281088 (NCT00143351).

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 344 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open Extension Study Evaluating the Safety and Tolerability of Oral Ziprasidone in the Treatment of Subjects Who Have Successfully Completed a Previous Ziprasidone Study
• Study Start Date: Mar 1, 2002
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to 72 months]

   All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects who have successfully completed a ziprasidone clinical study

• Patients not hospitalised in an acute psychiatric service

• Written, informed consent to participation.

• Female patients of at risk of pregnancy must avoid to remain pregnant; an adequate method of contraception (intrauterine device, implanted contraceptive, oral contraceptive or condom) must be initiated or continued

Exclusion Criteria:

Psychiatric:

• Subjects at immediate risk of committing harm to self or others

• Subjects requiring concurrent treatment with non-study antipsychotic agents

• Subjects requiring treatment with antidepressants or mood stabilizers

• General:

• Subjects with a history of clinically significant and/or currently relevant hematological, renal (including single kidney), hepatic, gastrointestinal, endocrine (except for current adequately treated hypo- or hyperthyroidism), pulmonary (excluding chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease), dermatological, oncological, or neurological disease, excluding tardive dyskinesia but including all forms of epilepsy (febrile convulsions in childhood acceptable). The only subjects with known prior malignant disease who are eligible are those with cured prior skin cancer (excluding melanoma). Controlled Type II diabetes (glucose < 180 mg/100 ml at screening and baseline with dietary or oral hypoglycemic treatment) will not be considered a significant medical illness and would not exclude a subject from the study

• Acute or chronic heart disease

• Clinically significant ECG abnormalities

• Subjects with QTc >= 500 msec (subjects with QTc >= 450 msec and < 500 msec should be discussed with the cardiologist who is responsible for all of the centers involved)

• Concomitant treatment with medications that prolong QTc interval (please review prescribing information of other treatments)

• Subjects with serum K+ or Mg++ outside the normal range

• Subject with any confirmed laboratory values that deviate from the upper or lower limits of normal prior to study entry, except for clinically insignificant deviations as determined by investigator

• Known serological evidence of HIV, or acute or chronic hepatitis (with transaminase levels higher than three times upper limit)

• Pregnant or lactating women

• Subjects who intend to donate blood or blood products during the 4 weeks prior to the study, during the study or in the 30 days after the study ends

• Subjects unable or unlikely to follow the study protocol

• Subjects with a history of neuroleptic malignant syndrome developing from the administration of antipsychotic compounds

• Known hypersensitivity to ziprasidone or lactose

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Sora	Frosinone	Italy	03039
2	Pfizer Investigational Site	Parma	PR	Italy	43100
3	Pfizer Investigational Site	Acri, CS		Italy	87041
4	Pfizer Investigational Site	Arezzo		Italy	52100
5	Pfizer Investigational Site	Arona (No)		Italy	28041
6	Pfizer Investigational Site	Bassano del Grappa		Italy	36061
7	Pfizer Investigational Site	Bisceglie (BA)		Italy	70052
8	Pfizer Investigational Site	Bologna		Italy	40100
9	Pfizer Investigational Site	Bologna		Italy	40122
10	Pfizer Investigational Site	Bolzano		Italy	39100
11	Pfizer Investigational Site	Brindisi		Italy	72100
12	Pfizer Investigational Site	Cagliari		Italy	09100
13	Pfizer Investigational Site	Casalecchio Di Reno BO		Italy	40033
14	Pfizer Investigational Site	Caserta		Italy	81100
15	Pfizer Investigational Site	Catania		Italy	95127
16	Pfizer Investigational Site	Cefalu' (Pa)		Italy	90015
17	Pfizer Investigational Site	Cesena FO		Italy	47023
18	Pfizer Investigational Site	Chiari (Bs)		Italy	25032
19	Pfizer Investigational Site	Cremona		Italy	26100
20	Pfizer Investigational Site	Crotone		Italy	88900
21	Pfizer Investigational Site	Cuneo		Italy	12100
22	Pfizer Investigational Site	Dolo (Ve)		Italy	30030
23	Pfizer Investigational Site	Empoli		Italy	50053
24	Pfizer Investigational Site	Enna		Italy	94100
25	Pfizer Investigational Site	Fano (PS)		Italy	61032
26	Pfizer Investigational Site	Formia (LT)		Italy	04023
27	Pfizer Investigational Site	Frattaminore (NA)		Italy	80020
28	Pfizer Investigational Site	Genova		Italy	16132
29	Pfizer Investigational Site	Genova		Italy	16149
30	Pfizer Investigational Site	Genova		Italy	16165
31	Pfizer Investigational Site	Genzano (RM)		Italy	00045
32	Pfizer Investigational Site	Giarre, CT		Italy	95014
33	Pfizer Investigational Site	Guardiagrele (CH)		Italy	66016
34	Pfizer Investigational Site	L'Aquila		Italy	67100
35	Pfizer Investigational Site	Lamezia Terme		Italy	88046
36	Pfizer Investigational Site	Lecce		Italy	73100
37	Pfizer Investigational Site	Livorno		Italy	57100
38	Pfizer Investigational Site	Matera		Italy	75100
39	Pfizer Investigational Site	Melzo (MI)		Italy	26066
40	Pfizer Investigational Site	Merano (BZ)		Italy	39012
41	Pfizer Investigational Site	Milano		Italy	20100
42	Pfizer Investigational Site	Milano		Italy	20122
43	Pfizer Investigational Site	Milano		Italy	20142
44	Pfizer Investigational Site	Montebelluna (TV)		Italy	31044
45	Pfizer Investigational Site	Montecchio Maggiore (VI)		Italy	36075
46	Pfizer Investigational Site	Montevarchi (AR)		Italy	52025
47	Pfizer Investigational Site	Monza MI		Italy	20052
48	Pfizer Investigational Site	Napoli		Italy	80136
49	Pfizer Investigational Site	Nocera Inferiore, SA		Italy	84014
50	Pfizer Investigational Site	Noto		Italy	96017
51	Pfizer Investigational Site	Novi Ligure, AL		Italy
52	Pfizer Investigational Site	Orbassano, TO		Italy	10043
53	Pfizer Investigational Site	Padova		Italy	35128
54	Pfizer Investigational Site	Palermo		Italy	90100
55	Pfizer Investigational Site	Palermo		Italy	90127
56	Pfizer Investigational Site	Palermo		Italy	90145
57	Pfizer Investigational Site	Partinico (Pa)		Italy	90047
58	Pfizer Investigational Site	Passirana Di Rho (Mi)		Italy	20017
59	Pfizer Investigational Site	Pavia		Italy	27100
60	Pfizer Investigational Site	Perugia		Italy	06127
61	Pfizer Investigational Site	Pisa		Italy	56126
62	Pfizer Investigational Site	Pordenone		Italy	33170
63	Pfizer Investigational Site	Portogruaro (Ve)		Italy	30026
64	Pfizer Investigational Site	Puglianello (BN)		Italy	82030
65	Pfizer Investigational Site	Ragusa		Italy	97100
66	Pfizer Investigational Site	Reggio Calabria		Italy	89100
67	Pfizer Investigational Site	Rivoli, TO		Italy	10098
68	Pfizer Investigational Site	Roma		Italy	00133
69	Pfizer Investigational Site	Roma		Italy	00144
70	Pfizer Investigational Site	Roma		Italy	00149
71	Pfizer Investigational Site	Roma		Italy	00152
72	Pfizer Investigational Site	Salerno		Italy	84100
73	Pfizer Investigational Site	San Benedetto Del Tronto, AP		Italy	63039
74	Pfizer Investigational Site	San Giorgio Di Piano BO		Italy	40016
75	Pfizer Investigational Site	San Marco In Lamis FG		Italy	71014
76	Pfizer Investigational Site	Sant'Arsenio (SA)		Italy	84037
77	Pfizer Investigational Site	Sassari		Italy	07100
78	Pfizer Investigational Site	Senigallia, AN		Italy	60019
79	Pfizer Investigational Site	Spoleto (PG)		Italy
80	Pfizer Investigational Site	Taranto		Italy	74100
81	Pfizer Investigational Site	Tivoli (RM)		Italy	00019
82	Pfizer Investigational Site	Torino		Italy	10147
83	Pfizer Investigational Site	Torino		Italy	10154
84	Pfizer Investigational Site	Treviso		Italy	31100
85	Pfizer Investigational Site	Udine		Italy	33100
86	Pfizer Investigational Site	Verona		Italy	37063
87	Pfizer Investigational Site	Viareggio		Italy	55049

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: NCT00139737
• Other Study ID Numbers: A1281061
• First Posted: Aug 31, 2005
• Last Update Posted: Mar 3, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: Open-label extension Ziprasidone study in Schizophrenia
• Additional relevant MeSH terms: Schizophrenia; Ziprasidone

Study Results

Participant Flow

Recruitment Details	This extension study enrolled eligible subjects with schizophrenia who had successfully completed a previous Phase 3 ziprasidone study (A1281028, A1281044 or A1281045 [NCT00136994]), allowing enrolled subjects to continue treatment with ziprasidone for at least 1 year or until the drug became commercially available.

Arm/Group Title	Ziprasidone
Arm/Group Description	Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator's opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
Period Title: Overall Study
STARTED	344
Received Treatment	331
COMPLETED	3
NOT COMPLETED	341

Baseline Characteristics

Arm/Group Title	Ziprasidone
Arm/Group Description	Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator's opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
Overall Participants	331
Age, Customized (Number) [Number]
18-44 years	238 71.9%
45-64 years	93 28.1%
Sex: Female, Male (Count of Participants)
Female	138 41.7%
Male	193 58.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.
Time Frame	Baseline up to 72 months

Outcome Measure Data

Analysis Population Description

Safety Analysis Set = All subjects who took at least 1 dose of study drug

Arm/Group Title	Ziprasidone
Arm/Group Description	Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator's opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
Measure Participants	331
AEs	177 53.5%
SAEs	32 9.7%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Ziprasidone
Arm/Group Description	Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator's opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
All Cause Mortality
	Ziprasidone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ziprasidone
	Affected / at Risk (%)	# Events
Total	32/331 (9.7%)
Cardiac disorders
Myocardial ischaemia	1/331 (0.3%)
Gastrointestinal disorders
Abdominal pain	1/331 (0.3%)
General disorders
Irritability	2/331 (0.6%)
Injury, poisoning and procedural complications
Accident	1/331 (0.3%)
Ankle fracture	2/331 (0.6%)
Femur fracture	1/331 (0.3%)
Head injury	1/331 (0.3%)
Intentional overdose	2/331 (0.6%)
Road traffic accident	1/331 (0.3%)
Tibia fracture	1/331 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/331 (0.3%)
Uterine leiomyoma	1/331 (0.3%)
Nervous system disorders
Epilepsy	1/331 (0.3%)
Mental impairment	1/331 (0.3%)
Psychiatric disorders
Aggression	2/331 (0.6%)
Agitation	2/331 (0.6%)
Alcohol abuse	2/331 (0.6%)
Anxiety	1/331 (0.3%)
Completed suicide	1/331 (0.3%)
Dysphoria	1/331 (0.3%)
Hypomania	1/331 (0.3%)
Schizophrenia	14/331 (4.2%)
Suicide attempt	1/331 (0.3%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	1/331 (0.3%)
Other (Not Including Serious) Adverse Events
	Ziprasidone
	Affected / at Risk (%)	# Events
Total	177/331 (53.5%)
Cardiac disorders
Arrhythmia	1/331 (0.3%)
Bundle branch block right	2/331 (0.6%)
Conduction disorder	1/331 (0.3%)
Extrasystoles	1/331 (0.3%)
Myocardial ischaemia	1/331 (0.3%)
Sinus tachycardia	2/331 (0.6%)
Tachycardia	2/331 (0.6%)
Endocrine disorders
Goitre	1/331 (0.3%)
Hyperprolactinaemia	5/331 (1.5%)
Hyperthyroidism	1/331 (0.3%)
Eye disorders
Diplopia	1/331 (0.3%)
Gastrointestinal disorders
Abdominal hernia	1/331 (0.3%)
Abdominal pain	2/331 (0.6%)
Colitis	1/331 (0.3%)
Constipation	1/331 (0.3%)
Diarrhoea	3/331 (0.9%)
Dry mouth	1/331 (0.3%)
Dyspepsia	5/331 (1.5%)
Flatulence	1/331 (0.3%)
Frequent bowel movements	1/331 (0.3%)
Gastritis	3/331 (0.9%)
Gastrointestinal disorder	1/331 (0.3%)
Gastrointestinal pain	1/331 (0.3%)
Nausea	7/331 (2.1%)
Stomatitis	1/331 (0.3%)
Toothache	3/331 (0.9%)
Vomiting	7/331 (2.1%)
General disorders
Asthenia	6/331 (1.8%)
Fatigue	1/331 (0.3%)
Gait disturbance	1/331 (0.3%)
Influenza like illness	1/331 (0.3%)
Irritability	1/331 (0.3%)
Pyrexia	3/331 (0.9%)
Swelling	1/331 (0.3%)
Hepatobiliary disorders
Cholelithiasis	1/331 (0.3%)
Hepatic pain	1/331 (0.3%)
Infections and infestations
Cystitis	2/331 (0.6%)
Ear infection	1/331 (0.3%)
Fungal infection	1/331 (0.3%)
Gastroenteritis	1/331 (0.3%)
Gingival abscess	1/331 (0.3%)
Helicobacter gastritis	1/331 (0.3%)
Influenza	7/331 (2.1%)
Labyrinthitis	1/331 (0.3%)
Laryngitis	2/331 (0.6%)
Nasopharyngitis	1/331 (0.3%)
Oral herpes	1/331 (0.3%)
Pharyngitis	1/331 (0.3%)
Tooth abscess	1/331 (0.3%)
Tracheitis	1/331 (0.3%)
Upper respiratory tract infection	1/331 (0.3%)
Urinary tract infection	1/331 (0.3%)
Vulvovaginal mycotic infection	1/331 (0.3%)
Injury, poisoning and procedural complications
Drug administration error	1/331 (0.3%)
Joint sprain	1/331 (0.3%)
Investigations
Alanine aminotransferase increased	2/331 (0.6%)
Aspartate aminotransferase increased	3/331 (0.9%)
Blood bilirubin increased	1/331 (0.3%)
Blood glucose increased	1/331 (0.3%)
Blood pressure increased	1/331 (0.3%)
Blood prolactin increased	5/331 (1.5%)
Electrocardiogram QT prolonged	46/331 (13.9%)
Electrocardiogram abnormal	11/331 (3.3%)
Glycosylated haemoglobin increased	1/331 (0.3%)
Laboratory test abnormal	1/331 (0.3%)
Lipids increased	1/331 (0.3%)
Transaminases increased	1/331 (0.3%)
Weight decreased	5/331 (1.5%)
Weight increased	6/331 (1.8%)
Metabolism and nutrition disorders
Anorexia	1/331 (0.3%)
Decreased appetite	2/331 (0.6%)
Diabetes mellitus	2/331 (0.6%)
Hyperglycaemia	1/331 (0.3%)
Hyperkalaemia	1/331 (0.3%)
Hypertriglyceridaemia	1/331 (0.3%)
Type 2 diabetes mellitus	1/331 (0.3%)
Musculoskeletal and connective tissue disorders
Bone pain	1/331 (0.3%)
Musculoskeletal pain	1/331 (0.3%)
Musculoskeletal stiffness	1/331 (0.3%)
Nervous system disorders
Akathisia	2/331 (0.6%)
Autism	1/331 (0.3%)
Cogwheel rigidity	1/331 (0.3%)
Dizziness	3/331 (0.9%)
Extrapyramidal disorder	6/331 (1.8%)
Headache	11/331 (3.3%)
Hemiparesis	1/331 (0.3%)
Memory impairment	1/331 (0.3%)
Presyncope	2/331 (0.6%)
Psychomotor hyperactivity	1/331 (0.3%)
Sedation	4/331 (1.2%)
Somnolence	11/331 (3.3%)
Tremor	3/331 (0.9%)
Psychiatric disorders
Affect lability	1/331 (0.3%)
Agitation	11/331 (3.3%)
Anxiety	15/331 (4.5%)
Apathy	1/331 (0.3%)
Confusional state	1/331 (0.3%)
Delirium	3/331 (0.9%)
Depression	11/331 (3.3%)
Disinhibition	2/331 (0.6%)
Dysphoria	1/331 (0.3%)
Elevated mood	1/331 (0.3%)
Euphoric mood	2/331 (0.6%)
Hallucination	2/331 (0.6%)
Hallucination, auditory	2/331 (0.6%)
Hypochondriasis	1/331 (0.3%)
Hypomania	2/331 (0.6%)
Insomnia	21/331 (6.3%)
Libido decreased	1/331 (0.3%)
Major depression	1/331 (0.3%)
Mood altered	1/331 (0.3%)
Nervousness	1/331 (0.3%)
Obsessive-compulsive disorder	1/331 (0.3%)
Panic attack	1/331 (0.3%)
Paranoia	1/331 (0.3%)
Psychiatric symptom	1/331 (0.3%)
Psychotic disorder	6/331 (1.8%)
Restlessness	2/331 (0.6%)
Schizophrenia	2/331 (0.6%)
Sleep disorder	5/331 (1.5%)
Tension	2/331 (0.6%)
Renal and urinary disorders
Urinary incontinence	1/331 (0.3%)
Reproductive system and breast disorders
Amenorrhoea	1/331 (0.3%)
Breast mass	1/331 (0.3%)
Ejaculation disorder	1/331 (0.3%)
Ejaculation failure	1/331 (0.3%)
Erectile dysfunction	2/331 (0.6%)
Gynaecomastia	1/331 (0.3%)
Metrorrhagia	1/331 (0.3%)
Respiratory, thoracic and mediastinal disorders
Cough	3/331 (0.9%)
Skin and subcutaneous tissue disorders
Dermatitis	2/331 (0.6%)
Erythema	1/331 (0.3%)
Guttate psoriasis	1/331 (0.3%)
Photosensitivity reaction	1/331 (0.3%)
Pruritus	1/331 (0.3%)
Psoriasis	1/331 (0.3%)
Vascular disorders
Hypertension	3/331 (0.9%)
Hypotension	3/331 (0.9%)

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 less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.