Trial Outcomes & Findings for Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia (NCT NCT00641745)
NCT ID: NCT00641745
Last Updated: 2015-06-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
629 participants
Primary outcome timeframe
12 months
Results posted on
2015-06-22
Participant Flow
Participant milestones
| Measure |
Lurasidone
Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
|
Risperidone
Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
|
|---|---|---|
|
Overall Study
STARTED
|
427
|
202
|
|
Overall Study
COMPLETED
|
147
|
89
|
|
Overall Study
NOT COMPLETED
|
280
|
113
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia
Baseline characteristics by cohort
| Measure |
Lurasidone
n=427 Participants
Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
|
Risperidone
n=202 Participants
Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
|
Total
n=629 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
41.6 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
41.7 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Gender
Female
|
117 participants
n=5 Participants
|
76 participants
n=7 Participants
|
193 participants
n=5 Participants
|
|
Gender
Male
|
302 participants
n=5 Participants
|
126 participants
n=7 Participants
|
428 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
279 participants
n=5 Participants
|
133 participants
n=7 Participants
|
412 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
24 participants
n=5 Participants
|
13 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
15 participants
n=5 Participants
|
9 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
13 participants
n=5 Participants
|
3 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
19 participants
n=5 Participants
|
7 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
59 participants
n=5 Participants
|
32 participants
n=7 Participants
|
91 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Lurasidone
n=427 Participants
Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
|
Risperidone
n=202 Participants
Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
|
|---|---|---|
|
Number of Participants With Adverse Events.
|
395 participants
|
189 participants
|
Adverse Events
Lurasidone
Serious events: 46 serious events
Other events: 349 other events
Deaths: 0 deaths
Risperidone
Serious events: 20 serious events
Other events: 169 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lurasidone
n=419 participants at risk
Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
|
Risperidone
n=202 participants at risk
Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
|
|---|---|---|
|
Cardiac disorders
Hypertensive Heart Disease
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Cardiac disorders
Sinus Tachycardia
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Eye disorders
Oculogyric Crisis
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Gastrointestinal disorders
Dysphagia
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
General disorders
Sudden Death
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Infections and infestations
Appendicitis
|
0.00%
0/419 • 14 days post-study therapy
|
0.50%
1/202 • Number of events 1 • 14 days post-study therapy
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/419 • 14 days post-study therapy
|
0.50%
1/202 • Number of events 1 • 14 days post-study therapy
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/419 • 14 days post-study therapy
|
0.50%
1/202 • Number of events 1 • 14 days post-study therapy
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Injury, poisoning and procedural complications
Fall
|
0.72%
3/419 • Number of events 3 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.48%
2/419 • Number of events 2 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.50%
1/202 • Number of events 1 • 14 days post-study therapy
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Nervous system disorders
Akathisia
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.50%
1/202 • Number of events 1 • 14 days post-study therapy
|
|
Nervous system disorders
Cerebrovascular accident
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Nervous system disorders
Dystonia
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.50%
1/202 • Number of events 1 • 14 days post-study therapy
|
|
Nervous system disorders
Loss of Consciousness
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Nervous system disorders
Parkinsonism
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Nervous system disorders
Syncope
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Nervous system disorders
Tremor
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Pregnancy, puerperium and perinatal conditions
Antepartum Hemorrhage
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Psychiatric disorders
Agitation
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Psychiatric disorders
Anxiety
|
0.48%
2/419 • Number of events 2 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Psychiatric disorders
Conduct Disorder
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Psychiatric disorders
Delusion of Reference
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Psychiatric disorders
Depression
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.50%
1/202 • Number of events 1 • 14 days post-study therapy
|
|
Psychiatric disorders
Insomnia
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.50%
1/202 • Number of events 1 • 14 days post-study therapy
|
|
Psychiatric disorders
Paranoia
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Psychiatric disorders
Psychotic Disorder
|
2.9%
12/419 • Number of events 12 • 14 days post-study therapy
|
4.0%
8/202 • Number of events 8 • 14 days post-study therapy
|
|
Psychiatric disorders
Schizoaffective Disorder
|
0.00%
0/419 • 14 days post-study therapy
|
0.50%
1/202 • Number of events 1 • 14 days post-study therapy
|
|
Psychiatric disorders
Schizophrenia
|
1.9%
8/419 • Number of events 8 • 14 days post-study therapy
|
1.5%
3/202 • Number of events 3 • 14 days post-study therapy
|
|
Psychiatric disorders
Suicidal Ideation
|
0.48%
2/419 • Number of events 2 • 14 days post-study therapy
|
0.99%
2/202 • Number of events 2 • 14 days post-study therapy
|
|
Psychiatric disorders
Suicide Attempt
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.50%
1/202 • Number of events 1 • 14 days post-study therapy
|
|
Respiratory, thoracic and mediastinal disorders
Dsypnea
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.24%
1/419 • Number of events 1 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
|
Social circumstances
Physical Assault
|
0.48%
2/419 • Number of events 2 • 14 days post-study therapy
|
0.00%
0/202 • 14 days post-study therapy
|
Other adverse events
| Measure |
Lurasidone
n=419 participants at risk
Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
|
Risperidone
n=202 participants at risk
Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.9%
8/419 • Number of events 8 • 14 days post-study therapy
|
6.9%
14/202 • Number of events 14 • 14 days post-study therapy
|
|
Gastrointestinal disorders
Nausea
|
16.7%
70/419 • Number of events 70 • 14 days post-study therapy
|
10.9%
22/202 • Number of events 22 • 14 days post-study therapy
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
42/419 • Number of events 42 • 14 days post-study therapy
|
3.5%
7/202 • Number of events 7 • 14 days post-study therapy
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
22/419 • Number of events 22 • 14 days post-study therapy
|
6.4%
13/202 • Number of events 13 • 14 days post-study therapy
|
|
Investigations
Weight Decreased
|
7.4%
31/419 • Number of events 31 • 14 days post-study therapy
|
4.5%
9/202 • Number of events 9 • 14 days post-study therapy
|
|
Investigations
Weight Increased
|
9.3%
39/419 • Number of events 39 • 14 days post-study therapy
|
19.8%
40/202 • Number of events 40 • 14 days post-study therapy
|
|
Nervous system disorders
Akathisia
|
14.3%
60/419 • Number of events 60 • 14 days post-study therapy
|
7.9%
16/202 • Number of events 16 • 14 days post-study therapy
|
|
Nervous system disorders
Dizziness
|
6.0%
25/419 • Number of events 25 • 14 days post-study therapy
|
4.0%
8/202 • Number of events 8 • 14 days post-study therapy
|
|
Nervous system disorders
Dystonia
|
2.9%
12/419 • Number of events 12 • 14 days post-study therapy
|
5.4%
11/202 • Number of events 11 • 14 days post-study therapy
|
|
Nervous system disorders
Headache
|
10.0%
42/419 • Number of events 42 • 14 days post-study therapy
|
14.9%
30/202 • Number of events 30 • 14 days post-study therapy
|
|
Nervous system disorders
Parkinsonism
|
4.3%
18/419 • Number of events 18 • 14 days post-study therapy
|
5.4%
11/202 • Number of events 11 • 14 days post-study therapy
|
|
Nervous system disorders
Sedation
|
14.6%
61/419 • Number of events 61 • 14 days post-study therapy
|
13.9%
28/202 • Number of events 28 • 14 days post-study therapy
|
|
Nervous system disorders
Somnolence
|
13.6%
57/419 • Number of events 57 • 14 days post-study therapy
|
17.8%
36/202 • Number of events 36 • 14 days post-study therapy
|
|
Psychiatric disorders
Anxiety
|
9.1%
38/419 • Number of events 38 • 14 days post-study therapy
|
8.4%
17/202 • Number of events 17 • 14 days post-study therapy
|
|
Psychiatric disorders
Insomnia
|
15.8%
66/419 • Number of events 66 • 14 days post-study therapy
|
13.4%
27/202 • Number of events 27 • 14 days post-study therapy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place