A Study of Galantamine Used to Treat Patients With Mild to Moderate Alzheimer's Disease

This study has been terminated.
(Due to a pre-specified imbalance of deaths between treatment groups, the DSMB recommended early termination of the trial)
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00679627
First received: May 15, 2008
Last updated: September 10, 2013
Last verified: September 2013
Results First Received: April 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Galantamine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study investigated the benefits and risks of long-term galantamine use in participants with Alzheimer's Disease. The study was conducted from 19 May 2008 to 20 May 2012 at 127 clinical centers in 13 countries. A total of 2051 participants were randomized to study treatment, of these 2045 received at least 1 dose of treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Data Safety Monitoring Board (DSMB) recommended that the study be terminated early because of an imbalance of deaths between the treatment groups.

Reporting Groups
  Description
Placebo During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
Galantamine During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.

Participant Flow:   Overall Study
    Placebo     Galantamine  
STARTED     1021     1024  
COMPLETED     322     339  
NOT COMPLETED     699     685  
Death                 41                 29  
Adverse Event                 43                 53  
Withdrawal by Subject                 168                 172  
Lost to Follow-up                 22                 26  
Early Study Closure                 425                 405  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
Galantamine During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
Total Total of all reporting groups

Baseline Measures
    Placebo     Galantamine     Total  
Number of Participants  
[units: participants]
  1021     1024     2045  
Age  
[units: participants]
Mean ± Standard Deviation
  73.2  ± 8.67     73  ± 8.88     73.1  ± 8.77  
Age, Customized  
[units: participants]
     
<61     112     112     224  
61-<76     467     466     933  
>=76     442     446     888  
Gender  
[units: participants]
     
Female     654     671     1325  
Male     367     353     720  
Region of Enrollment  
[units: participants]
     
Czech Republic     33     34     67  
Estonia     53     51     104  
France     10     11     21  
Germany     218     221     439  
Greece     35     36     71  
Italy     25     24     49  
Latvia     2     2     4  
Lithuania     23     21     44  
Romania     84     84     168  
Russia     274     271     545  
Slovakia     85     88     173  
Slovenia     13     13     26  
Ukraine     166     168     334  



  Outcome Measures
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1.  Primary:   Change From Baseline in the Mini–Mental State Examination (MMSE) Score   [ Time Frame: Baseline, Month 24 ]

2.  Primary:   The Number of Deaths Reported in Participants   [ Time Frame: Up to 2 years ]

3.  Secondary:   Change From Baseline in the Mini–Mental State Examination (MMSE) Score   [ Time Frame: Baseline, Month 6 ]

4.  Secondary:   Change From Baseline in Disability Assessment in Dementia (DAD) Scores   [ Time Frame: Baseline, Month 24 ]

5.  Secondary:   Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)   [ Time Frame: Baseline, Months 12 and 24 ]

6.  Secondary:   Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)   [ Time Frame: Baseline, Months 12 and 24 ]

7.  Secondary:   Change From Baseline in Institutional Status   [ Time Frame: Baseline, Month 24 ]

8.  Secondary:   Change From Baseline in the Mini–Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)   [ Time Frame: Baseline, Month 24 ]

9.  Secondary:   Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)   [ Time Frame: Baseline, Month 24 ]


  Serious Adverse Events
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Time Frame Over 2 years
Additional Description No text entered.

Reporting Groups
  Description
Placebo During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
Galantamine During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.

Serious Adverse Events
    Placebo     Galantamine  
Total, serious adverse events      
# participants affected / at risk     123/1021 (12.05%)     129/1024 (12.60%)  
Blood and lymphatic system disorders      
Anaemia * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Cardiac disorders      
Acute Myocardial Infarction * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
Arrhythmia * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Arteriosclerosis Coronary Artery * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Atrial Fibrillation * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
Bradyarrhythmia * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Bradycardia * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
Cardiac Arrest * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Cardiac Failure * 1    
# participants affected / at risk     3/1021 (0.29%)     10/1024 (0.98%)  
Cardiac Failure Acute * 1    
# participants affected / at risk     2/1021 (0.20%)     2/1024 (0.20%)  
Cardio-Respiratory Arrest * 1    
# participants affected / at risk     3/1021 (0.29%)     0/1024 (0.00%)  
Cardiopulmonary Failure * 1    
# participants affected / at risk     4/1021 (0.39%)     3/1024 (0.29%)  
Cardiovascular Insufficiency * 1    
# participants affected / at risk     3/1021 (0.29%)     1/1024 (0.10%)  
Ischaemic Cardiomyopathy * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Myocardial Infarction * 1    
# participants affected / at risk     2/1021 (0.20%)     6/1024 (0.59%)  
Myocardial Ischaemia * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
Postinfarction Angina * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Tachyarrhythmia * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Ear and labyrinth disorders      
Vertigo * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Eye disorders      
Cataract * 1    
# participants affected / at risk     0/1021 (0.00%)     2/1024 (0.20%)  
Cataract Subcapsular * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Glaucoma * 1    
# participants affected / at risk     0/1021 (0.00%)     2/1024 (0.20%)  
Lens Disorder * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Gastrointestinal disorders      
Anal Polyp * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Colitis Ischaemic * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Diarrhoea * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Duodenal Ulcer Perforation * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Dysphagia * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Enterocolitis * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Enterocolitis Haemorrhagic * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Faecal Incontinence * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Gastric Ulcer * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Gastric Ulcer Haemorrhage * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Gastroduodenitis * 1    
# participants affected / at risk     0/1021 (0.00%)     2/1024 (0.20%)  
Haemorrhagic Erosive Gastritis * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Haemorrhoidal Haemorrhage * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Haemorrhoids * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Ileus * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Inguinal Hernia * 1    
# participants affected / at risk     0/1021 (0.00%)     2/1024 (0.20%)  
Intestinal Stenosis * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Nausea * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Oesophageal Achalasia * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Pancreatitis * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Peritoneal Haemorrhage * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Upper Gastrointestinal Haemorrhage * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Varices Oesophageal * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Vomiting * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
General disorders      
Abasia * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Death * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Hypothermia * 1    
# participants affected / at risk     2/1021 (0.20%)     0/1024 (0.00%)  
Inflammation * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Multi-Organ Failure * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Oedema Peripheral * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Pyrexia * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
Sudden Death * 1    
# participants affected / at risk     3/1021 (0.29%)     1/1024 (0.10%)  
Hepatobiliary disorders      
Bile Duct Stone * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Cholecystitis * 1    
# participants affected / at risk     1/1021 (0.10%)     2/1024 (0.20%)  
Infections and infestations      
Abscess * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Bronchitis * 1    
# participants affected / at risk     0/1021 (0.00%)     2/1024 (0.20%)  
Bronchopneumonia * 1    
# participants affected / at risk     3/1021 (0.29%)     2/1024 (0.20%)  
Clostridium Difficile Colitis * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Ear Infection * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Gastroenteritis Rotavirus * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Gastrointestinal Infection * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Herpes Zoster * 1    
# participants affected / at risk     1/1021 (0.10%)     2/1024 (0.20%)  
Peritonitis * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Pneumonia * 1    
# participants affected / at risk     6/1021 (0.59%)     8/1024 (0.78%)  
Post Procedural Infection * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Sepsis * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Tuberculosis * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Urinary Tract Infection * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
Urosepsis * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Injury, poisoning and procedural complications      
Accidental Overdose * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Carbon Monoxide Poisoning * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Chemical Poisoning * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Exposure to Toxic Agent * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Fall * 1    
# participants affected / at risk     3/1021 (0.29%)     2/1024 (0.20%)  
Femoral Neck Fracture * 1    
# participants affected / at risk     3/1021 (0.29%)     2/1024 (0.20%)  
Femur Fracture * 1    
# participants affected / at risk     3/1021 (0.29%)     3/1024 (0.29%)  
Forearm Fracture * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
Hand Fracture * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Head Injury * 1    
# participants affected / at risk     2/1021 (0.20%)     1/1024 (0.10%)  
Hip Fracture * 1    
# participants affected / at risk     3/1021 (0.29%)     1/1024 (0.10%)  
Humerus Fracture * 1    
# participants affected / at risk     1/1021 (0.10%)     2/1024 (0.20%)  
Injury * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Joint Dislocation * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
Lower Limb Fracture * 1    
# participants affected / at risk     0/1021 (0.00%)     2/1024 (0.20%)  
Lumbar Vertebral Fracture * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Multiple Fractures * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Patella Fracture * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Rib Fracture * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Skeletal Injury * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Spinal Fracture * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Subdural Haematoma * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Subdural Haemorrhage * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Upper Limb Fracture * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Urethral Injury * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Wound Haemorrhage * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Investigations      
Blood Pressure Increased * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Weight Decreased * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Metabolism and nutrition disorders      
Decreased Appetite * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Dehydration * 1    
# participants affected / at risk     1/1021 (0.10%)     4/1024 (0.39%)  
Diabetes Mellitus * 1    
# participants affected / at risk     2/1021 (0.20%)     2/1024 (0.20%)  
Hyperglycaemia * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Musculoskeletal and connective tissue disorders      
Back Pain * 1    
# participants affected / at risk     2/1021 (0.20%)     1/1024 (0.10%)  
Bone Pain * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Intervertebral Disc Compression * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Muscular Weakness * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Musculoskeletal Pain * 1    
# participants affected / at risk     2/1021 (0.20%)     1/1024 (0.10%)  
Osteoarthritis * 1    
# participants affected / at risk     0/1021 (0.00%)     2/1024 (0.20%)  
Spinal Column Stenosis * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Spinal Osteoarthritis * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Adenocarcinoma Pancreas * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Breast Cancer * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
Colon Cancer * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
Hepatic Neoplasm Malignant * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Pancreatic Neoplasm * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Pharyngeal Neoplasm * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Prostatic Adenoma * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Rectal Cancer * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Salivary Gland Adenoma * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Nervous system disorders      
Altered State of Consciousness * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Cerebral Arteriosclerosis * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Cerebral Haemorrhage * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
Cerebral Infarction * 1    
# participants affected / at risk     2/1021 (0.20%)     1/1024 (0.10%)  
Cerebrovascular Accident * 1    
# participants affected / at risk     2/1021 (0.20%)     4/1024 (0.39%)  
Cerebrovascular Disorder * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
Coma * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Dementia * 1    
# participants affected / at risk     2/1021 (0.20%)     0/1024 (0.00%)  
Dementia Alzheimer's Type * 1    
# participants affected / at risk     12/1021 (1.18%)     9/1024 (0.88%)  
Diabetic Neuropathy * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Epilepsy * 1    
# participants affected / at risk     3/1021 (0.29%)     0/1024 (0.00%)  
Haemorrhage Intracranial * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Haemorrhagic Stroke * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Ischaemic Stroke * 1    
# participants affected / at risk     8/1021 (0.78%)     2/1024 (0.20%)  
Loss of Consciousness * 1    
# participants affected / at risk     1/1021 (0.10%)     3/1024 (0.29%)  
Polyneuropathy * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Presyncope * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Speech Disorder * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Syncope * 1    
# participants affected / at risk     3/1021 (0.29%)     3/1024 (0.29%)  
Transient Ischaemic Attack * 1    
# participants affected / at risk     3/1021 (0.29%)     2/1024 (0.20%)  
Vertebrobasilar Insufficiency * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Psychiatric disorders      
Abnormal Behaviour * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Adjustment Disorder * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Aggression * 1    
# participants affected / at risk     1/1021 (0.10%)     3/1024 (0.29%)  
Agitation * 1    
# participants affected / at risk     2/1021 (0.20%)     1/1024 (0.10%)  
Catatonia * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Confusional State * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Delirium * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
Depression * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Disorientation * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Psychotic Disorder * 1    
# participants affected / at risk     0/1021 (0.00%)     2/1024 (0.20%)  
Restlessness * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Suicide Attempt * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Renal and urinary disorders      
Incontinence * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Nephritis * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Renal Failure Acute * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Renal Failure Chronic * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Stress Urinary Incontinence * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Tubulointerstitial Nephritis * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Urinary Incontinence * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Urinary Retention * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
Reproductive system and breast disorders      
Benign Prostatic Hyperplasia * 1    
# participants affected / at risk     0/1021 (0.00%)     2/1024 (0.20%)  
Pelvic Pain * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Scrotal Disorder * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Vulval Leukoplakia * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Acute Lung Injury * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Aspiration * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Bronchitis Chronic * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Chronic Obstructive Pulmonary Disease * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Dyspnoea * 1    
# participants affected / at risk     1/1021 (0.10%)     2/1024 (0.20%)  
Emphysema * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Pneumonia Aspiration * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Pneumothorax * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Pulmonary Embolism * 1    
# participants affected / at risk     1/1021 (0.10%)     5/1024 (0.49%)  
Pulmonary Oedema * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Respiratory Failure * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Skin and subcutaneous tissue disorders      
Decubitus Ulcer * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Psoriasis * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Rash * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Surgical and medical procedures      
Carotid Artery Stent Removal * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Vascular disorders      
Arteriosclerosis * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Circulatory Collapse * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Essential Hypertension * 1    
# participants affected / at risk     0/1021 (0.00%)     2/1024 (0.20%)  
Haemorrhagic Infarction * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Hypertension * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
Hypertensive Crisis * 1    
# participants affected / at risk     0/1021 (0.00%)     1/1024 (0.10%)  
Hypotension * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Malignant Hypertension * 1    
# participants affected / at risk     1/1021 (0.10%)     1/1024 (0.10%)  
Pallor * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
Peripheral Arterial Occlusive Disease * 1    
# participants affected / at risk     1/1021 (0.10%)     0/1024 (0.00%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA Version 15.0




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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director, Clinical Research
Organization: Johnson & Johnson Pharmaceutical Research & Development
phone: 1 609-730-7674


No publications provided


Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00679627     History of Changes
Other Study ID Numbers: CR012463, GALALZ3005
Study First Received: May 15, 2008
Results First Received: April 23, 2013
Last Updated: September 10, 2013
Health Authority: Germany: Ethics Commission
Greece: National Organization of Medicines
Austria: Ethikkommission
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Comité Ético de Investigación Clínica
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Austria: Agency for Health and Food Safety
Germany: Federal Institute for Drugs and Medical Devices
France: Institutional Ethical Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Estonia: The State Agency of Medicine
Czech Republic: State Institute for Drug Control
Italy: Ethics Committee
Ukraine: State Pharmacological Center - Ministry of Health