ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    Safety and Efficacy of Brimonidine Intravitreal Implant
Previous Study | Return to List | Next Study

Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00658619
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : April 26, 2013
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Macular Degeneration
Interventions Drug: 400 µg Brimonidine Tartrate Implant
Drug: 200 µg Brimonidine Tartrate Implant
Other: Sham (no implant)
Enrollment 119

Recruitment Details  
Pre-assignment Details Stage 1 of the study was a patient-masked, dose-escalation, paired-eye comparison and the Investigator was not masked. Stage 2 was a parallel-group, sham-controlled, paired-eye comparison. Investigators were masked as to dose received for patients in the active treatment groups. No patients from Stage 1 were enrolled in Stage 2.
Arm/Group Title 400 µg Brimonidine Tartrate Implant Stage 1 200 µg Brimonidine Tartrate Implant Stage 1 400 µg Brimonidine Tartrate Implant Stage 2 200 µg Brimonidine Tartrate Implant Stage 2 Sham (no Implant) Stage 2
Hide Arm/Group Description Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. Stage 2: sham in both eyes on Day 1 and Month 6.
Period Title: Overall Study
Started 3 3 41 49 23
Completed 3 2 31 37 21
Not Completed 0 1 10 12 2
Arm/Group Title 400 µg Brimonidine Tartrate Implant Stage 1 200 µg Brimonidine Tartrate Implant Stage 1 400 µg Brimonidine Tartrate Implant Stage 2 200 µg Brimonidine Tartrate Implant Stage 2 Sham (no Implant) Stage 2 Total
Hide Arm/Group Description Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. Stage 2: sham in both eyes on Day 1 and Month 6. Total of all reporting groups
Overall Number of Baseline Participants 3 3 41 49 23 119
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 41 participants 49 participants 23 participants 119 participants
85.0  (3.61) 79.0  (3.00) 75.6  (8.78) 77.0  (9.13) 78.4  (5.80) 77.0  (8.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 41 participants 49 participants 23 participants 119 participants
Female
3
 100.0%
2
  66.7%
27
  65.9%
28
  57.1%
12
  52.2%
72
  60.5%
Male
0
   0.0%
1
  33.3%
14
  34.1%
21
  42.9%
11
  47.8%
47
  39.5%
1.Primary Outcome
Title Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Hide Description Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2).
Time Frame Baseline, Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: All randomized patients who participated in Stage 2
Arm/Group Title 400 µg Brimonidine Tartrate Implant Stage 2 200 µg Brimonidine Tartrate Implant Stage 2 Sham (no Implant) Stage 2
Hide Arm/Group Description:
Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
Stage 2: sham in both eyes on Day 1 and Month 6.
Overall Number of Participants Analyzed 41 49 23
Mean (Standard Deviation)
Unit of Measure: Disc Area
Baseline 6.219  (3.9524) 6.897  (4.6397) 5.526  (4.7890)
Change from Baseline at Month 12 0.898  (0.7520) 1.006  (0.7858) 1.239  (1.1645)
2.Secondary Outcome
Title Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Hide Description Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2).
Time Frame Baseline, Month 3, Month 6, Month 9, Month 18, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: All randomized patients who participated in Stage 2
Arm/Group Title 400 µg Brimonidine Tartrate Implant Stage 2 200 µg Brimonidine Tartrate Implant Stage 2 Sham (no Implant) Stage 2
Hide Arm/Group Description:
Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
Stage 2: sham in both eyes on Day 1 and Month 6.
Overall Number of Participants Analyzed 41 49 23
Mean (Standard Deviation)
Unit of Measure: Disc Area
Baseline 6.219  (3.9524) 6.897  (4.6397) 5.526  (4.7890)
Change from Baseline at Month 3 0.182  (0.3353) 0.117  (0.6612) 0.399  (0.3713)
Change from Baseline at Month 6 0.482  (0.6325) 0.570  (0.5749) 0.609  (0.5474)
Change from Baseline at Month 9 0.641  (0.6847) 0.798  (0.6424) 0.857  (0.7267)
Change from Baseline at Month 18 1.306  (1.0164) 1.413  (1.0291) 1.697  (1.4185)
Change from Baseline at Month 24 1.744  (1.4010) 1.991  (1.4469) 2.178  (1.7042)
3.Secondary Outcome
Title Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Hide Description BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Time Frame Baseline, 24 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: All randomized patients who participated in Stage 2
Arm/Group Title 400 µg Brimonidine Tartrate Implant Stage 2 200 µg Brimonidine Tartrate Implant Stage 2 Sham (no Implant) Stage 2
Hide Arm/Group Description:
Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
Stage 2: sham in both eyes on Day 1 and Month 6.
Overall Number of Participants Analyzed 41 49 23
Mean (Standard Deviation)
Unit of Measure: Number of Letters Read Correctly
Baseline 54.8  (12.89) 52.1  (13.91) 53.7  (10.71)
Change from Baseline at 24 Months -5.0  (13.77) -3.2  (12.87) -3.3  (12.98)
4.Secondary Outcome
Title Change From Baseline in Contrast Sensitivity in the Study Eye
Hide Description Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.
Time Frame Baseline, 24 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: All randomized patients who participated in Stage 2
Arm/Group Title 400 µg Brimonidine Tartrate Implant Stage 2 200 µg Brimonidine Tartrate Implant Stage 2 Sham (no Implant) Stage 2
Hide Arm/Group Description:
Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
Stage 2: sham in both eyes on Day 1 and Month 6.
Overall Number of Participants Analyzed 41 49 23
Mean (Standard Deviation)
Unit of Measure: Number of Letters Read Correctly
Baseline 23.7  (5.60) 22.1  (5.76) 21.7  (7.56)
Change from Baseline at 24 Months -0.9  (4.33) 1.1  (7.22) 0.6  (7.49)
5.Secondary Outcome
Title Change From Baseline in Reading Speed in the Study Eye
Hide Description Change from baseline in reading speed in the study eye is assessed using modified Bailey-Lovie word charts. Patients read the chart for 2 minutes and the numbers of words read correctly per minute are totaled. An increase in the number of words read correctly indicates an improvement and a decrease in the number of words read correctly indicates a worsening.
Time Frame Baseline, 24 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: All randomized patients who participated in Stage 2
Arm/Group Title 400 µg Brimonidine Tartrate Implant Stage 2 200 µg Brimonidine Tartrate Implant Stage 2 Sham (no Implant) Stage 2
Hide Arm/Group Description:
Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
Stage 2: sham in both eyes on Day 1 and Month 6.
Overall Number of Participants Analyzed 41 49 23
Mean (Standard Deviation)
Unit of Measure: Words per Minute (wpm)
Baseline 10.21  (8.532) 9.62  (9.224) 8.72  (6.832)
Change from Baseline at 24 Months -1.15  (5.527) -0.28  (7.035) 0.45  (4.705)
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
 
Arm/Group Title 400 µg Brimonidine Tartrate Implant 200 µg Brimonidine Tartrate Implant Sham (no Implant) Stage 2
Hide Arm/Group Description Stage 1 and 2 combined: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. Stage 1 and 2 combined: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. Stage 2: sham in both eyes on Day 1 and Month 6.
All-Cause Mortality
400 µg Brimonidine Tartrate Implant 200 µg Brimonidine Tartrate Implant Sham (no Implant) Stage 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
400 µg Brimonidine Tartrate Implant 200 µg Brimonidine Tartrate Implant Sham (no Implant) Stage 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/43 (32.56%)   20/51 (39.22%)   9/23 (39.13%) 
Blood and lymphatic system disorders       
Anaemia  1  0/43 (0.00%)  1/51 (1.96%)  1/23 (4.35%) 
Cardiac disorders       
Angina Unstable  1  1/43 (2.33%)  0/51 (0.00%)  0/23 (0.00%) 
Cardiac Failure Congestive  1  1/43 (2.33%)  1/51 (1.96%)  0/23 (0.00%) 
Coronary Artery Disease  1  1/43 (2.33%)  1/51 (1.96%)  0/23 (0.00%) 
Acute Myocardial Infarction  1  1/43 (2.33%)  1/51 (1.96%)  1/23 (4.35%) 
Atrial Fibrillation  1  1/43 (2.33%)  1/51 (1.96%)  1/23 (4.35%) 
Myocardial Infarction  1  1/43 (2.33%)  2/51 (3.92%)  0/23 (0.00%) 
Angina Pectoris  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Aortic Valve Stenosis  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Atrial Flutter  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Mitral Valve Stenosis  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Sick Sinus Syndrome  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Ear and labyrinth disorders       
Vertigo  1  1/43 (2.33%)  0/51 (0.00%)  0/23 (0.00%) 
Eye disorders       
Visual Acuity Reduced * 1  1/43 (2.33%)  0/51 (0.00%)  0/23 (0.00%) 
Gastrointestinal disorders       
Abdominal Pain Lower * 1  1/43 (2.33%)  0/51 (0.00%)  0/23 (0.00%) 
Diverticulum  1  1/43 (2.33%)  0/51 (0.00%)  0/23 (0.00%) 
Small Intestinal Obstruction  1  1/43 (2.33%)  0/51 (0.00%)  0/23 (0.00%) 
Gastrointestinal Haemorrhage  1  0/43 (0.00%)  0/51 (0.00%)  1/23 (4.35%) 
Oesophageal Stenosis  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Infections and infestations       
Diarrhoea Infectious * 1  1/43 (2.33%)  0/51 (0.00%)  0/23 (0.00%) 
Urosepsis  1  1/43 (2.33%)  0/51 (0.00%)  0/23 (0.00%) 
Pneumonia  1  1/43 (2.33%)  1/51 (1.96%)  1/23 (4.35%) 
Clostridium Difficile Colitis  1  0/43 (0.00%)  0/51 (0.00%)  1/23 (4.35%) 
Diverticulitis  1  0/43 (0.00%)  0/51 (0.00%)  1/23 (4.35%) 
Urinary Tract Infection Bacterial  1  0/43 (0.00%)  0/51 (0.00%)  1/23 (4.35%) 
Cellulitis  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Injury, poisoning and procedural complications       
Hip Fracture  1  1/43 (2.33%)  1/51 (1.96%)  1/23 (4.35%) 
Spinal Compression Fracture  1  0/43 (0.00%)  0/51 (0.00%)  2/23 (8.70%) 
Femoral Neck Fracture  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Road Traffic Accident * 1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Femur Fracture  1  0/43 (0.00%)  2/51 (3.92%)  0/23 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  1/43 (2.33%)  0/51 (0.00%)  0/23 (0.00%) 
Hyponatraemia  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Musculoskeletal and connective tissue disorders       
Flank Pain * 1  1/43 (2.33%)  0/51 (0.00%)  0/23 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bowen’s Disease  1  1/43 (2.33%)  0/51 (0.00%)  0/23 (0.00%) 
Lung Squamous Cell Carcinoma Stage Unspecified  1  1/43 (2.33%)  0/51 (0.00%)  0/23 (0.00%) 
Squamous Cell Carcinoma  1  1/43 (2.33%)  0/51 (0.00%)  0/23 (0.00%) 
Basal Cell Carcinoma  1  1/43 (2.33%)  1/51 (1.96%)  1/23 (4.35%) 
Bladder Cancer  1  0/43 (0.00%)  0/51 (0.00%)  1/23 (4.35%) 
Laryngeal Cancer  1  0/43 (0.00%)  0/51 (0.00%)  1/23 (4.35%) 
Malignant Melanoma  1  0/43 (0.00%)  0/51 (0.00%)  1/23 (4.35%) 
Lung Cancer Metastatic  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Non-Hodgkin’s Lymphoma  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Small Cell Lung Cancer Stage Unspecified  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Transitional Cell Carcinoma  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Nervous system disorders       
Syncope * 1  1/43 (2.33%)  0/51 (0.00%)  1/23 (4.35%) 
Cerebrovascular Accident  1  1/43 (2.33%)  2/51 (3.92%)  0/23 (0.00%) 
Carotid Artery Stenosis  1  0/43 (0.00%)  0/51 (0.00%)  1/23 (4.35%) 
Dizziness * 1  0/43 (0.00%)  0/51 (0.00%)  1/23 (4.35%) 
Intracranial Aneurysm  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Transient Ischaemic Attack  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Renal and urinary disorders       
Renal Failure Acute  1  1/43 (2.33%)  0/51 (0.00%)  0/23 (0.00%) 
Stress Urinary Incontinence * 1  1/43 (2.33%)  0/51 (0.00%)  0/23 (0.00%) 
Haematuria  1  0/43 (0.00%)  0/51 (0.00%)  1/23 (4.35%) 
Nephrolithiasis  1  0/43 (0.00%)  0/51 (0.00%)  1/23 (4.35%) 
Urinary Retention * 1  0/43 (0.00%)  0/51 (0.00%)  1/23 (4.35%) 
Renal Failure  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary Vascular Disorder  1  1/43 (2.33%)  0/51 (0.00%)  0/23 (0.00%) 
Pulmonary Embolism  1  0/43 (0.00%)  0/51 (0.00%)  1/23 (4.35%) 
Respiratory Failure  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Vascular disorders       
Hypotension  1  0/43 (0.00%)  0/51 (0.00%)  1/23 (4.35%) 
Aortic Stenosis  1  0/43 (0.00%)  1/51 (1.96%)  0/23 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
400 µg Brimonidine Tartrate Implant 200 µg Brimonidine Tartrate Implant Sham (no Implant) Stage 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   38/43 (88.37%)   47/51 (92.16%)   20/23 (86.96%) 
Blood and lymphatic system disorders       
Anaemia  1  1/43 (2.33%)  5/51 (9.80%)  3/23 (13.04%) 
Leukocytosis  1  0/43 (0.00%)  3/51 (5.88%)  0/23 (0.00%) 
Cardiac disorders       
Coronary Artery Disease  1  1/43 (2.33%)  2/51 (3.92%)  2/23 (8.70%) 
Angina pectoris  1  0/43 (0.00%)  3/51 (5.88%)  1/23 (4.35%) 
Endocrine disorders       
Hypothyroidism  1  0/43 (0.00%)  1/51 (1.96%)  2/23 (8.70%) 
Eye disorders       
Conjunctival Haemorrhage  1  12/43 (27.91%)  21/51 (41.18%)  2/23 (8.70%) 
Punctate Keratitis  1  5/43 (11.63%)  1/51 (1.96%)  0/23 (0.00%) 
Eye Pain * 1  5/43 (11.63%)  1/51 (1.96%)  1/23 (4.35%) 
Vitreous Floaters * 1  3/43 (6.98%)  2/51 (3.92%)  0/23 (0.00%) 
Cataract  1  4/43 (9.30%)  3/51 (5.88%)  1/23 (4.35%) 
Retinal Haemorrhage  1  3/43 (6.98%)  3/51 (5.88%)  2/23 (8.70%) 
Posterior Capsule Opacification  1  3/43 (6.98%)  0/51 (0.00%)  0/23 (0.00%) 
Visual Acuity Reduced * 1  3/43 (6.98%)  3/51 (5.88%)  0/23 (0.00%) 
Conjunctival Hyperaemia  1  3/43 (6.98%)  7/51 (13.73%)  3/23 (13.04%) 
Vitreous Haemorrhage  1  2/43 (4.65%)  3/51 (5.88%)  0/23 (0.00%) 
Vitreous Detachment  1  2/43 (4.65%)  1/51 (1.96%)  2/23 (8.70%) 
Gastrointestinal disorders       
Dental Caries  1  0/43 (0.00%)  0/51 (0.00%)  2/23 (8.70%) 
Constipation * 1  0/43 (0.00%)  3/51 (5.88%)  2/23 (8.70%) 
Nausea * 1  0/43 (0.00%)  3/51 (5.88%)  3/23 (13.04%) 
Infections and infestations       
Sinusitis  1  4/43 (9.30%)  0/51 (0.00%)  1/23 (4.35%) 
Urinary Tract Infection  1  3/43 (6.98%)  5/51 (9.80%)  2/23 (8.70%) 
Ear Infection  1  1/43 (2.33%)  2/51 (3.92%)  2/23 (8.70%) 
Pneumonia  1  1/43 (2.33%)  3/51 (5.88%)  1/23 (4.35%) 
Injury, poisoning and procedural complications       
Fall * 1  1/43 (2.33%)  3/51 (5.88%)  1/23 (4.35%) 
Spinal Compression Fracture  1  0/43 (0.00%)  0/51 (0.00%)  2/23 (8.70%) 
Musculoskeletal and connective tissue disorders       
Back Pain * 1  1/43 (2.33%)  0/51 (0.00%)  3/23 (13.04%) 
Arthralgia * 1  0/43 (0.00%)  3/51 (5.88%)  1/23 (4.35%) 
Nervous system disorders       
Syncope * 1  3/43 (6.98%)  1/51 (1.96%)  2/23 (8.70%) 
Cerebrovascular Accident  1  1/43 (2.33%)  3/51 (5.88%)  0/23 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis  1  0/43 (0.00%)  0/51 (0.00%)  2/23 (8.70%) 
Respiratory, thoracic and mediastinal disorders       
Sleep Apnoea Syndrome  1  0/43 (0.00%)  0/51 (0.00%)  2/23 (8.70%) 
Skin and subcutaneous tissue disorders       
Urticaria * 1  0/43 (0.00%)  0/51 (0.00%)  2/23 (8.70%) 
Vascular disorders       
Hypertension  1  2/43 (4.65%)  1/51 (1.96%)  4/23 (17.39%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 10.0
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.
A 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00658619     History of Changes
Other Study ID Numbers: 190342-032D
First Submitted: April 11, 2008
First Posted: April 15, 2008
Results First Submitted: March 13, 2013
Results First Posted: April 26, 2013
Last Update Posted: August 21, 2018