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Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout

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: NCT00325195
Recruitment Status : Completed
First Posted : May 12, 2006
Results First Posted : February 25, 2011
Last Update Posted : February 28, 2011
Sponsor:
Information provided by:
Savient Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Gout
Interventions Other: placebo
Biological: pegloticase
Enrollment 225

Recruitment Details Rheumatology practices across the US, Canada and Mexico
Pre-assignment Details 13 subjects were randomized but withdrew before intervention. These subjects were not part of the modified Intent to Treat Population, which included only subjects who received at least one dose of study drug.
Arm/Group Title q2 Wks q4 Wks Placebo
Hide Arm/Group Description 8 mg pegloticase every 2 weeks 8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks) placebo infusion every 2 weeks
Period Title: Randomized
Started 90 89 46
Completed 85 84 43
Not Completed 5 5 3
Reason Not Completed
Not dosed             5             5             3
Period Title: Received Intervention: ITT Population
Started 85 84 43
Completed 59 59 39
Not Completed 26 25 4
Reason Not Completed
Adverse Event             15             17             1
Death             3             1             0
Withdrawal by Subject             7             6             1
Lost to Follow-up             0             0             2
Protocol violation/non-compliance             1             1             0
Arm/Group Title q2 Wks q4 Wks Placebo Total
Hide Arm/Group Description 8 mg pegloticase every 2 weeks 8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks) placebo infusion every 2 weeks Total of all reporting groups
Overall Number of Baseline Participants 85 84 43 212
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 84 participants 43 participants 212 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
56
  65.9%
65
  77.4%
31
  72.1%
152
  71.7%
>=65 years
29
  34.1%
19
  22.6%
12
  27.9%
60
  28.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 85 participants 84 participants 43 participants 212 participants
56.3  (15.53) 54.5  (13.34) 55.4  (12.21) 55.4  (14.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 84 participants 43 participants 212 participants
Female
17
  20.0%
15
  17.9%
7
  16.3%
39
  18.4%
Male
68
  80.0%
69
  82.1%
36
  83.7%
173
  81.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 85 participants 84 participants 43 participants 212 participants
United States 73 77 39 189
Canada 1 1 1 3
Mexico 11 6 3 20
1.Primary Outcome
Title Plasma Uric Acid (PUA) Responder
Hide Description PUA Responder was defined as a participant who achieved and maintained plasma uric acid concentrations < 6 mg/dL for at least 80% of the time during months 3 and 6 combined. Participants who withdrew from the study before month 6 were considered non-responders.
Time Frame Months 3 and 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified ITT (all patients receiving at least one dose of study drug). Participants dropping out before Week 25 were imputed as Non-Responders
Arm/Group Title q2 Wks q4 Wks Placebo
Hide Arm/Group Description:
8 mg pegloticase every 2 weeks
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
placebo infusion every 2 weeks
Overall Number of Participants Analyzed 85 84 43
Measure Type: Number
Unit of Measure: Participants
36 29 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection q2 Wks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection q4 Wks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Reduction in Tophus Burden
Hide Description percentage of tophaceous subjects who demonstrated a complete resolution (100 % decrease in measured area or complete disappearance)of at least one tophus in the absence of other tophus progression or new tophi, as assessed by a blinded Central Reader using standardized digital photographs and image analysis software.
Time Frame Baseline and Final Visit (6 months or LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed was based upon the number of patients who had one or more tophus at Baseline, as determined by the PI, AND who had at least one follow-up assessment, with the final visit for each subject included (last observation carried forward).
Arm/Group Title q2 Wks q4 Wks Placebo
Hide Arm/Group Description:
8 mg pegloticase every 2 weeks
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
placebo infusion every 2 weeks
Overall Number of Participants Analyzed 52 52 27
Measure Type: Number
Unit of Measure: Percent subjects with resolved tophus
40 21 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection q2 Wks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.002
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection q4 Wks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.200
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Subjects With Gout Flare Per 3-month Period
Hide Description Percent of participants reporting a gout flare during Months 1-3 and Months 4-6. Denominator during the respective period was based upon number of participants during that period.
Time Frame Months 1-3 and Months 4-6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number analyzed in each period was based upon number of participants remaining in study during the assessed treatment period: 85/84/43 in Months 1-3 and 69/69/43 in Months 4-6
Arm/Group Title q2 Wks q4 Wks Placebo
Hide Arm/Group Description:
8 mg pegloticase every 2 weeks
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
placebo infusion every 2 weeks
Overall Number of Participants Analyzed 85 84 43
Measure Type: Number
Unit of Measure: Percent subjects reporting flares
Months 1-3 75 81 54
Months 4-6 41 56 67
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection q2 Wks, Placebo
Comments % of pegloticase q2 participants reporting flares compared to placebo pts during Months 4-6 treatment period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection q4 Wks, Placebo
Comments % of pegloticase q4 participants reporting flares compared to placebo pts during Months 4-6 treatment period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.321
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Change in Number of Swollen Joints
Hide Description Change from Baseline to Month 6 (or last observation carried forward)in number of swollen joints per subject. Values were inputed using last observation carried forward analysis for subjects who did not complete the studies.
Time Frame Baseline and Final Visit (Month 6 or LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All ITT participants with baseline and at least one post-baseline assessment were included in analysis. LOCF was used for participants dropping out early.
Arm/Group Title q2 Wks q4 Wks Placebo
Hide Arm/Group Description:
8 mg pegloticase every 2 weeks
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
placebo infusion every 2 weeks
Overall Number of Participants Analyzed 78 77 43
Mean (Standard Deviation)
Unit of Measure: Swollen joints
-5.5  (10.47) -5.1  (7.83) -2.6  (11.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection q2 Wks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.166
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection q4 Wks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.170
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Change in Number of Tender Joints
Hide Description Change from Baseline to Month 6 (or last observation carried forward) in number of tender joints per participant
Time Frame Baseline and Final Visit (Month 6 or LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All ITT participants with baseline and at least one post-baseline assessment were included in analysis. LOCF was used for participants dropping out early.
Arm/Group Title q2 Wks q4 Wks Placebo
Hide Arm/Group Description:
8 mg pegloticase every 2 weeks
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
placebo infusion every 2 weeks
Overall Number of Participants Analyzed 78 77 43
Mean (Standard Deviation)
Unit of Measure: Tender joints
-7.4  (11.95) -6.1  (10.64) -1.2  (12.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection q2 Wks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection q4 Wks, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Change in Patient Reported Outcomes of Pain, Physical Function and Quality of Life
Hide Description Health Assessment Questionnaire(HAQ: VAS pain scale where 0 (no pain)-100 (severe pain); HAQ disability index (HAQ-DI) on a scale from 0(no disability) to 3 (completely disabled), and a unit change of > or =0.22 is considerd a mimimal clinically important difference(MCID). SF-36 Physical Component Summary Score (SF36-PCS), a composite score where 0 is the worst score and 100 the best possible, and where a change of > or =2.5 units in the PCS is considered a MCID.
Time Frame Baseline to Final Visit (Month 6 or LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed was based upon the number who had baseline and at least one follow-up assessment, with the final visit for each subject included (LOCF).
Arm/Group Title q2 Wks q4 Wks Placebo
Hide Arm/Group Description:
8 mg pegloticase every 2 weeks
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
placebo infusion every 2 weeks
Overall Number of Participants Analyzed 77 77 43
Mean (Standard Deviation)
Unit of Measure: Units on a scale
HAQ-VAS Pain -11.4  (33.8) -6.9  (27.0) 1.4  (30.0)
HAQ-DI -0.22  (0.64) -0.20  (0.55) 0.0  (0.41)
SF-36 PCS 4.4  (9.4) 4.9  (8.5) -0.3  (9.0)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title q2 Wks q4 Wks Placebo
Hide Arm/Group Description 8 mg pegloticase every 2 weeks 8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks) placebo infusion every 2 weeks
All-Cause Mortality
q2 Wks q4 Wks Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
q2 Wks q4 Wks Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/85 (23.53%)      19/84 (22.62%)      5/43 (11.63%)    
Blood and lymphatic system disorders       
Febrile Neutropenia  1  0/85 (0.00%)  0 0/84 (0.00%)  0 1/43 (2.33%)  1
Cardiac disorders       
Arrhythmia  1  2/85 (2.35%)  2 0/84 (0.00%)  0 0/43 (0.00%)  0
Angina Pectoris  1  0/85 (0.00%)  0 1/84 (1.19%)  1 0/43 (0.00%)  0
Cardiac Arrest  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Cardiac Failure Congestive  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Myocardial Infarction  1  0/85 (0.00%)  0 1/84 (1.19%)  1 0/43 (0.00%)  0
Tachycardia  1  0/85 (0.00%)  0 1/84 (1.19%)  1 0/43 (0.00%)  0
Gastrointestinal disorders       
Gatrooesophageal Reflux Disease  1  2/85 (2.35%)  2 0/84 (0.00%)  0 0/43 (0.00%)  0
Pancreatitis  1  0/85 (0.00%)  0 1/84 (1.19%)  1 1/43 (2.33%)  1
Barrett's Oesophagus  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Gastritis Erosive  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Inguinal Hernia, Obstructive  1  0/85 (0.00%)  0 0/84 (0.00%)  0 1/43 (2.33%)  1
General disorders       
Infusion Related Reaction  1  4/85 (4.71%)  4 7/84 (8.33%)  7 0/43 (0.00%)  0
Chest Pain  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Oedoma Peripheral  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Pyrexia  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis  1  0/85 (0.00%)  0 1/84 (1.19%)  1 0/43 (0.00%)  0
Infections and infestations       
Pneumonia  1  1/85 (1.18%)  1 1/84 (1.19%)  1 1/43 (2.33%)  1
Cellulitis  1  1/85 (1.18%)  2 1/84 (1.19%)  1 0/43 (0.00%)  0
Arthritis Bacterial  1  0/85 (0.00%)  0 0/84 (0.00%)  0 1/43 (2.33%)  1
Cellulitis Staphylococcal  1  0/85 (0.00%)  0 1/84 (1.19%)  1 0/43 (0.00%)  0
Herpes Zoster  1  0/85 (0.00%)  0 0/84 (0.00%)  0 1/43 (2.33%)  1
Necrotising Fasciitis  1  0/85 (0.00%)  0 1/84 (1.19%)  1 0/43 (0.00%)  0
Perianal Abscess  1  0/85 (0.00%)  0 0/84 (0.00%)  0 1/43 (2.33%)  1
Pyelonephritis  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Sepsis  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Staphyloccal Sepsis  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Injury, poisoning and procedural complications       
Facial Bones Fracture  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Injury  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Muscle Rupture  1  1/85 (1.18%)  2 0/84 (0.00%)  0 0/43 (0.00%)  0
Metabolism and nutrition disorders       
Hyperkalaemia  1  1/85 (1.18%)  1 1/84 (1.19%)  2 0/43 (0.00%)  0
Hypoglycaemia  1  0/85 (0.00%)  0 0/84 (0.00%)  0 1/43 (2.33%)  1
Musculoskeletal and connective tissue disorders       
Localised Infection  1  0/85 (0.00%)  0 1/84 (1.19%)  1 0/43 (0.00%)  0
Gout  1  4/85 (4.71%)  4 1/84 (1.19%)  1 2/43 (4.65%)  2
Fistula  1  0/85 (0.00%)  0 1/84 (1.19%)  1 0/43 (0.00%)  0
Haemarthrosis  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Myopathy Steroid  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Osteoarthritis  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Synovial Cyst  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Chronic Lymphocytic Leukaemia Recurrent  1  0/85 (0.00%)  0 0/84 (0.00%)  0 1/43 (2.33%)  1
Malignant Melanoma  1  0/85 (0.00%)  0 1/84 (1.19%)  1 0/43 (0.00%)  0
Nervous system disorders       
Convulsion  1  0/85 (0.00%)  0 1/84 (1.19%)  1 0/43 (0.00%)  0
Syncope  1  0/85 (0.00%)  0 0/84 (0.00%)  0 1/43 (2.33%)  1
Transient Ischaemic Attack  1  0/85 (0.00%)  0 1/84 (1.19%)  1 0/43 (0.00%)  0
Renal and urinary disorders       
Renal Failure Acute  1  0/85 (0.00%)  0 1/84 (1.19%)  1 1/43 (2.33%)  1
Haematuria  1  0/85 (0.00%)  0 0/84 (0.00%)  0 1/43 (2.33%)  1
Renal Failure  1  0/85 (0.00%)  0 1/84 (1.19%)  1 0/43 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  1/85 (1.18%)  1 0/84 (0.00%)  0 0/43 (0.00%)  0
Dyspnoea Exacerbated  1  0/85 (0.00%)  0 1/84 (1.19%)  1 0/43 (0.00%)  0
Skin and subcutaneous tissue disorders       
Angioneurotic Oedema  1  0/85 (0.00%)  0 1/84 (1.19%)  1 0/43 (0.00%)  0
Urticaria  1  0/85 (0.00%)  0 1/84 (1.19%)  1 0/43 (0.00%)  0
Vascular disorders       
Deep Vein Thrombosis  1  0/85 (0.00%)  0 1/84 (1.19%)  1 0/43 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
q2 Wks q4 Wks Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   69/85 (81.18%)      79/84 (94.05%)      36/43 (83.72%)    
Blood and lymphatic system disorders       
Anaemia  1  7/85 (8.24%)  4/84 (4.76%)  4/43 (9.30%) 
Cardiac disorders       
Tachycardia  1  1/85 (1.18%)  4/84 (4.76%)  0/43 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  9/85 (10.59%)  14/84 (16.67%)  8/43 (18.60%) 
Nausea  1  10/85 (11.76%)  6/84 (7.14%)  1/43 (2.33%) 
Vomiting  1  4/85 (4.71%)  5/84 (5.95%)  1/43 (2.33%) 
Constipation  1  5/85 (5.88%)  2/84 (2.38%)  2/43 (4.65%) 
General disorders       
Oedema Peripheral  1  9/85 (10.59%)  11/84 (13.10%)  6/43 (13.95%) 
Fatigue  1  5/85 (5.88%)  6/84 (7.14%)  4/43 (9.30%) 
Chest Pain  1  4/85 (4.71%)  4/84 (4.76%)  1/43 (2.33%) 
Pain  1  4/85 (4.71%)  4/84 (4.76%)  2/43 (4.65%) 
Pyrexia  1  1/85 (1.18%)  5/84 (5.95%)  1/43 (2.33%) 
Asthenia  1  2/85 (2.35%)  4/84 (4.76%)  0/43 (0.00%) 
Infections and infestations       
Upper Respiratory Tract Infection  1  4/85 (4.71%)  4/84 (4.76%)  9/43 (20.93%) 
Urinary Tract Infection  1  6/85 (7.06%)  5/84 (5.95%)  3/43 (6.98%) 
Nasopharyngitis  1  6/85 (7.06%)  4/84 (4.76%)  1/43 (2.33%) 
Localised Infection  1  2/85 (2.35%)  4/84 (4.76%)  3/43 (6.98%) 
Injury, poisoning and procedural complications       
Contusion  1  7/85 (8.24%)  0/84 (0.00%)  1/43 (2.33%) 
Investigations       
Blood Glucose Increased  1  4/85 (4.71%)  2/84 (2.38%)  1/43 (2.33%) 
Blood Pressure Increased  1  0/85 (0.00%)  6/84 (7.14%)  0/43 (0.00%) 
Metabolism and nutrition disorders       
Hyperglycaemia  1  4/85 (4.71%)  1/84 (1.19%)  1/43 (2.33%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  6/85 (7.06%)  15/84 (17.86%)  8/43 (18.60%) 
Back Pain  1  3/85 (3.53%)  7/84 (8.33%)  2/43 (4.65%) 
Muscle Spasms  1  3/85 (3.53%)  5/84 (5.95%)  4/43 (9.30%) 
Joint Swelling  1  4/85 (4.71%)  0/84 (0.00%)  0/43 (0.00%) 
Pain in Extremity  1  4/85 (4.71%)  4/84 (4.76%)  3/43 (6.98%) 
Musculoskeletal Pain  1  1/85 (1.18%)  4/84 (4.76%)  0/43 (0.00%) 
Nervous system disorders       
Headache  1  8/85 (9.41%)  9/84 (10.71%)  4/43 (9.30%) 
Dizziness  1  3/85 (3.53%)  7/84 (8.33%)  4/43 (9.30%) 
Psychiatric disorders       
Insomnia  1  5/85 (5.88%)  8/84 (9.52%)  4/43 (9.30%) 
Depression  1  3/85 (3.53%)  4/84 (4.76%)  4/43 (9.30%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  3/85 (3.53%)  5/84 (5.95%)  2/43 (4.65%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  3/85 (3.53%)  5/84 (5.95%)  0/43 (0.00%) 
Vascular disorders       
Hypertension  1  2/85 (2.35%)  5/84 (5.95%)  3/43 (6.98%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
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.
Multicenter publication is to be generated before any individual PI publishes on the results. If multicenter publication is not completed within 18 months from the date of completion, then PI can publish individual results from the Study. Sponsor can review results prior to public release and embargo for no more than 90 days. Sponsor can request removal of Confidential Information only.
Results Point of Contact
Name/Title: Medical Director
Organization: Savient Pharmaceuticals, Inc.
Phone: 732-418-9300
Responsible Party: Savient Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00325195     History of Changes
Other Study ID Numbers: C0405 & C0406
First Submitted: May 10, 2006
First Posted: May 12, 2006
Results First Submitted: October 13, 2010
Results First Posted: February 25, 2011
Last Update Posted: February 28, 2011