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Trial record 99 of 1163 for:    MYCOPHENOLIC ACID

Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare

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ClinicalTrials.gov Identifier: NCT00423098
Recruitment Status : Completed
First Posted : January 17, 2007
Results First Posted : June 28, 2011
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lupus Nephritis
Interventions Drug: Mycophenolate sodium
Drug: Prednisone
Drug: Methylprednisolone
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Dose Low Dose
Hide Arm/Group Description Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks. Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Period Title: Overall Study
Started 42 [1] 39
Completed 39 [2] 35
Not Completed 3 4
Reason Not Completed
Adverse Event             1             2
Unsatisfactory therapeutic effect             0             1
Administrative problems             0             1
Death             2             0
[1]
Total number of patients screened was 90, but the total number of randomized patients was 81.
[2]
Completed 24 weeks of study medication.
Arm/Group Title Standard Dose Low Dose Total
Hide Arm/Group Description Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks. Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 42 39 81
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 39 participants 81 participants
32.2  (8.53) 34.2  (10.74) 33.1  (9.65)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 39 participants 81 participants
18-29 years 20 18 38
30-39 years 16 10 26
40-49 years 4 6 10
50-59 years 2 4 6
>=60 years 0 1 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 39 participants 81 participants
Female
37
  88.1%
29
  74.4%
66
  81.5%
Male
5
  11.9%
10
  25.6%
15
  18.5%
1.Primary Outcome
Title Number of Patients With Complete Remission
Hide Description Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab.
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.
Arm/Group Title Standard Dose Low Dose
Hide Arm/Group Description:
Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Overall Number of Participants Analyzed 42 39
Measure Type: Number
Unit of Measure: Participants
Yes 8 8
No 34 31
2.Secondary Outcome
Title Number of Patients With Complete Remission
Hide Description Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal value.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.
Arm/Group Title Standard Dose Low Dose
Hide Arm/Group Description:
Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Overall Number of Participants Analyzed 42 39
Measure Type: Number
Unit of Measure: participants
Yes 9 5
No 33 34
3.Secondary Outcome
Title Number of Patients With Partial Remission
Hide Description Partial remission was defined as urine protein/creatinine ratio reduced by at least 50% from baseline and stable serum creatinine within 10% of baseline value) or improved.
Time Frame Baseline to 12 and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.
Arm/Group Title Standard Dose Low Dose
Hide Arm/Group Description:
Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Overall Number of Participants Analyzed 42 39
Measure Type: Number
Unit of Measure: Participants
At 12 weeks - Yes 16 11
At 12 weeks - No 26 28
At 24 weeks - Yes 20 14
At 24 weeks - No 22 25
4.Secondary Outcome
Title Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)
Hide Description Corticosteroid use was measured as cumulative dose until 12 and 24 weeks of treatment as well as daily doses at baseline, 12 and 24 weeks.
Time Frame 12 Weeks and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.
Arm/Group Title Standard Dose Low Dose
Hide Arm/Group Description:
Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Overall Number of Participants Analyzed 42 39
Mean (Standard Deviation)
Unit of Measure: mg/kg
Week 12 106.1  (13.55) 68.2  (16.41)
Week 24 114.2  (15.01) 73.0  (17.76)
5.Secondary Outcome
Title Number of Patients With Moderate to Severe Flares
Hide Description A moderate to severe flare was defined as the occurrence of increased lupus activity after partial or complete remission, based on the presence of 1 BILAG A score or >=3 BILAG B scores. British Isles Lupus Assessment Group (BILAG) index divides lupus activity in 8 organs/systems which are each given a score of A to E. A=disease sufficiently active to need disease modifying treatment; B=problems requiring symptomatic treatment; C=mild stable disease; D=previously affected but currently inactive system; E=the system or organ has never been involved. BILAG score: A=9, B=3, C=1, D/E=0; range(0-72)
Time Frame 12 and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.
Arm/Group Title Standard Dose Low Dose
Hide Arm/Group Description:
Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Overall Number of Participants Analyzed 42 39
Measure Type: Number
Unit of Measure: participants
At week 12 - Yes 0 0
At week 12 - No 42 39
At week 24 - Yes 1 0
At week 24 - No 41 39
6.Secondary Outcome
Title Duration of Exposure to Study Medication
Hide Description The duration of exposure was calculated as the date of the last Mycophenolate sodium dose minus the date of the last Mycophenolate sodium dose +1.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Arm/Group Title Standard Dose Low Dose
Hide Arm/Group Description:
Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Overall Number of Participants Analyzed 42 39
Mean (Standard Deviation)
Unit of Measure: days
164.5  (24.87) 157.7  (41.15)
7.Secondary Outcome
Title Number of Patients With Adverse Events and Infections
Hide Description Safety assessments included collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Arm/Group Title Standard Dose Low Dose
Hide Arm/Group Description:
Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Overall Number of Participants Analyzed 42 39
Measure Type: Number
Unit of Measure: participants
At least one adverse event 35 30
Any severe adverse event 7 3
Any drug related adverse event 18 16
Any serious adverse event 8 4
Any infection 25 17
Any severe infection 3 1
Any drug related infection 10 6
Any serious infection 4 1
8.Secondary Outcome
Title Number of Patients With Treatment Failure
Hide Description Treatment failure was defined as no therapeutic response (without complete or partial remission) or premature discontinuation during the first 24 weeks from study medication or the study for any reason except complete or partial remission.
Time Frame 12 Weeks and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Arm/Group Title Standard Dose Low Dose
Hide Arm/Group Description:
Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Overall Number of Participants Analyzed 42 39
Measure Type: Number
Unit of Measure: participants
At 12 weeks - Yes 23 25
At 12 weeks - No 19 14
At 24 weeks - Yes 21 22
At 24 weeks - No 21 17
9.Secondary Outcome
Title Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)
Hide Description SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index and was a well established global score index based on assessment of 24 items measuring a disease activity in the 10-day period prior to the assessment. SLEDAI item weights range from 1 for fever to 8 for seizures. A maximum theoretical score is 105. Total score range from 1 to 105. A flare has been defined as a SLEDAI score increase of 3 or more to a level of 8 or higher. During flares SLEDAI scores of 25 to 30 are common.
Time Frame From Baseline to week 4, week 12 and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all randomized patients who received at least one dose of study drug. Only patients with assessments at both baseline and post-baseline visits are summarized.
Arm/Group Title Standard Dose Low Dose
Hide Arm/Group Description:
Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Overall Number of Participants Analyzed 42 39
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change from Baseline to Week 4: (N= 39, 37) -7.4  (5.63) -7.7  (6.62)
Change from Baseline to Week 12: (N= 41, 35) -9.7  (7.08) -10.3  (8.31)
Change from Baseline to Week 24: (N= 39, 34) -10.3  (7.32) -9.8  (8.35)
10.Secondary Outcome
Title Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)
Hide Description BILAG (British Isles Lupus Assessment Group) index divides lupus activity into 8 organs/systems and was based on the principle of the physician's intention to treat, assessing activity in the previous one month. Each organ or system was given a score of A to E, where A = disease that is sufficiently active to require disease modifying treatment; a B = problems requiring symptomatic treatment; C = stable mild disease; D = previously affected but currently inactive system; and E = the system or organ has never been involved. [A=9, B=3, C=1, D/E=0 the score range for each patient will be 0-72].
Time Frame From Baseline to week 4, week 12 and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) populationincluded all randomized patients who received at least one dose of study drug. Only patients with assessments at both baseline and post-baseline visits are summarized.
Arm/Group Title Standard Dose Low Dose
Hide Arm/Group Description:
Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Overall Number of Participants Analyzed 42 39
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change from baseline Week 4: (N= 40, 37) -4.8  (5.34) -5.5  (6.50)
Change from baseline Week 12: (N= 41, 35) -8.6  (6.76) -8.7  (6.19)
Change from baseline Week 24: (N= 40, 34) -8.6  (5.79) -9.4  (5.52)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Dose Low Dose
Hide Arm/Group Description Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks. Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
All-Cause Mortality
Standard Dose Low Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Dose Low Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   8/42 (19.05%)   4/39 (10.26%) 
Gastrointestinal disorders     
Diarrhoea  1  1/42 (2.38%)  0/39 (0.00%) 
Pancreatitis acute  1  1/42 (2.38%)  0/39 (0.00%) 
Vomiting  1  1/42 (2.38%)  0/39 (0.00%) 
General disorders     
Death  1  1/42 (2.38%)  0/39 (0.00%) 
Mucosal inflammation  1  1/42 (2.38%)  0/39 (0.00%) 
Multi-organ failure  1  1/42 (2.38%)  0/39 (0.00%) 
Oedema peripheral  1  1/42 (2.38%)  0/39 (0.00%) 
Infections and infestations     
Cytomegalovirus infection  1  1/42 (2.38%)  0/39 (0.00%) 
Epstein-barr virus infection  1  1/42 (2.38%)  0/39 (0.00%) 
Gastroenteritis  1  1/42 (2.38%)  1/39 (2.56%) 
Herpes zoster  1  1/42 (2.38%)  0/39 (0.00%) 
Sinusitis  1  1/42 (2.38%)  0/39 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  0/42 (0.00%)  1/39 (2.56%) 
Tendon rupture  1  1/42 (2.38%)  1/39 (2.56%) 
Nervous system disorders     
Headache  1  0/42 (0.00%)  1/39 (2.56%) 
Syncope  1  0/42 (0.00%)  1/39 (2.56%) 
Renal and urinary disorders     
Renal failure acute  1  1/42 (2.38%)  0/39 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dysphonia  1  1/42 (2.38%)  0/39 (0.00%) 
Vascular disorders     
Hypertension  1  1/42 (2.38%)  1/39 (2.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Dose Low Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   28/42 (66.67%)   18/39 (46.15%) 
Blood and lymphatic system disorders     
Anaemia  1  1/42 (2.38%)  3/39 (7.69%) 
Cardiac disorders     
Tachycardia  1  1/42 (2.38%)  2/39 (5.13%) 
Gastrointestinal disorders     
Abdominal pain upper  1  1/42 (2.38%)  3/39 (7.69%) 
Constipation  1  3/42 (7.14%)  1/39 (2.56%) 
Diarrhoea  1  9/42 (21.43%)  8/39 (20.51%) 
Gastritis  1  0/42 (0.00%)  2/39 (5.13%) 
Nausea  1  3/42 (7.14%)  1/39 (2.56%) 
Vomiting  1  3/42 (7.14%)  4/39 (10.26%) 
General disorders     
Oedema peripheral  1  4/42 (9.52%)  5/39 (12.82%) 
Infections and infestations     
Folliculitis  1  0/42 (0.00%)  2/39 (5.13%) 
Herpes zoster  1  6/42 (14.29%)  0/39 (0.00%) 
Nasopharyngitis  1  4/42 (9.52%)  1/39 (2.56%) 
Upper respiratory tract infection  1  4/42 (9.52%)  2/39 (5.13%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/42 (9.52%)  5/39 (12.82%) 
Muscle spasms  1  3/42 (7.14%)  1/39 (2.56%) 
Musculoskeletal stiffness  1  0/42 (0.00%)  2/39 (5.13%) 
Psychiatric disorders     
Insomnia  1  4/42 (9.52%)  4/39 (10.26%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/42 (7.14%)  2/39 (5.13%) 
Vascular disorders     
Hypertension  1  2/42 (4.76%)  2/39 (5.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00423098     History of Changes
Other Study ID Numbers: CERL080A2420
First Submitted: January 16, 2007
First Posted: January 17, 2007
Results First Submitted: December 14, 2010
Results First Posted: June 28, 2011
Last Update Posted: June 28, 2011