Dose Response of Valsartan on Sitting Systolic Blood Pres... | NCT00435162 | Trialant
NCT00435162
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
May 9, 2011Estimated
Enrollment
74Actual
Phase
Phase 3
Conditions
Hypertension
Interventions
Valsartan 0.25 mg/kg
Valsartan 1.0 mg/kg
Valsartan 4.0 mg/kg
Countries
United States
Belgium
Brazil
France
Hungary
India
Italy
Poland
South Africa
Sweden
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT00435162
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CVAL489K2303
Secondary IDs
Not provided
Brief Title
Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure
Official Title
A Randomized, Multicenter, Double-blind, 6 Week Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 6 Months - 5 Years Old With Hypertension, Followed by a 2 Week Placebo Withdrawal Period.
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Apr 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 2007
Primary Completion Date
Jan 2009Actual
Completion Date
Jan 2009Actual
First Submitted Date
Feb 13, 2007
First Submission Date that Met QC Criteria
Feb 13, 2007
First Posted Date
Feb 14, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 17, 2010
Results First Submitted that Met QC Criteria
Apr 15, 2011
Results First Posted Date
May 9, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 17, 2010
Certification/Extension First Submitted that Passed QC Review
Apr 15, 2011
Certification/Extension First Posted Date
May 9, 2011Estimated
Last Update Submitted Date
Apr 15, 2011
Last Update Posted Date
May 9, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure [SSBP] ≥ 95th percentile ).
Detailed Description
Not provided
Conditions Module
Conditions
Hypertension
Keywords
Children
pediatrics
High Blood Pressure
Hypertension
Valsartan
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
74Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Low Dose
Experimental
Drug: Valsartan 0.25 mg/kg
Medium Dose
Experimental
Drug: Valsartan 1.0 mg/kg
High Dose
Experimental
Drug: Valsartan 4.0 mg/kg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Valsartan 0.25 mg/kg
Drug
once daily
Low Dose
Valsartan 1.0 mg/kg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)
baseline and week 6
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)
baseline and week 6
Change From End of Period 1 (Week 6) in Mean Sitting Systolic Blood Pressure (MSSBP) to End of Placebo-controlled Withdrawal Period (Week 8)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Children aged 6 months - 5 years at Visit 1, with a documented history of hypertension
Must be able to swallow liquid formulation
Must be ≥ 6 kg or ≤ 40 kg at randomization
Must have documented history MSSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at randomization
If patients enter with uncontrolled BP they can remain on background antihypertensives with an unchanged dosing regimen
If patients have had a solid organ transplant more than 1 year ago they must be on stable doses of immunosuppressive therapy
Parent(s)/guardian(s) are able to follow verbal and/or written instructions in the local language
Exclusion Criteria:
Patients with background ARB therapy
Patients demonstrating any clinically significant abnormalities or clinically noteworthy abnormal lab values (other than those relating to renal function)
AST/SGOT or ALT/SGPT > 3 times the upper limit of the reference range
Glomerular filtration rate < 30 mL/min/1.73m²
Serum potassium > upper limit of the reference range
Patients that have coarctation of the aorta with a gradient of ≥ 30 mm Hg, or renal artery stenosis
Other protocol-defined inclusion/exclusion criteria may apply
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
6 Months
Maximum Age
5 Years
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Pharmaceuticals
Sponsor GmbH
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Sites in USA
USA
New Jersey
United States
Sites in Belgium
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
At period 1, participants were randomized (2:1:2) to Valsartan 0.25 mg/kg, 1.0 mg/kg or 4.0 mg/kg. At period 2, participants were randomized (1:1) to either stay on Valsartan or switch to placebo.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Low Dose in Both Periods
Valsartan 0.25 mg/kg in both periods
FG001
Low Dose, Then Placebo
Valsartan 0.25 mg/kg, then placebo
Periods
Title
Milestones
Reasons Not Completed
Period 1 (6 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Czechia
Germany
Lithuania
Russia
Slovakia
Switzerland
United Kingdom
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Drug
once daily
Medium Dose
Valsartan 4.0 mg/kg
Drug
once daily
High Dose
week 6 and week 8
Change From End of Period 1 (Week 6) in Mean Sitting Diastolic Blood Pressure (MSDBP) to End of Placebo-controlled Withdrawal Period (Week 8)
week 6 and week 8
Belgium
Belgium
Sites in Brazil
Brazil
Brazil
Sites in France
Paris
France
Sites in Hungary
Hungary
Hungary
Sites in India
India
India
sites in Italy
Italy
Italy
Sites in Poland
Poland
Poland
Sites in South Africa
South Africa
South Africa
Sites in Sweden
Sweden
Sweden
Sites in Turkey
Turkey
Turkey (Türkiye)
FG002
Medium Dose in Both Periods
Valsartan 1.0 mg/kg in both periods
FG003
Medium Dose, Then Placebo
Valsartan 1.0 mg/kg, then placebo
FG004
High Dose in Both Periods
Valsartan 1.0 mg/kg, then placebo
FG005
High Dose, Then Placebo
Valsartan 4.0 mg/kg, then placebo
FG00015 subjects
FG00115 subjects
FG0026 subjects
FG0038 subjects
FG00415 subjects
FG00515 subjects
COMPLETED
FG00015 subjects
FG00115 subjects
FG0026 subjects
FG0038 subjects
FG00415 subjects
FG00515 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Period 2 (2 Weeks)
Type
Comment
Milestone Data
STARTED
FG00015 subjects
FG00115 subjects
FG0026 subjects
FG0038 subjects
FG00415 subjects
FG00515 subjects
COMPLETED
FG00015 subjects
FG00114 subjects
FG0026 subjects
FG0038 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Low Dose
Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
BG001
Medium Dose
Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
BG002
High Dose
Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00030
BG00114
BG00230
BG00374
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0003.4± 1.28
BG0013.2± 1.48
BG0023.3± 1.53
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG0014
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)
Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)
Posted
Mean
Standard Deviation
mm Hg
baseline and week 6
ID
Title
Description
OG000
Low Dose
Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
OG001
Medium Dose
Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
OG002
High Dose
Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
Units
Counts
Participants
OG00030
OG00114
OG00230
Title
Denominators
Categories
Title
Measurements
OG000-8.3± 10.44
OG001-10.3± 9.83
OG002-14.4± 10.93
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
Slope change across all 3 active treatment groups.
Regression, Linear
0.0990
Slope
-1.05
2-Sided
95
-2.31
0.20
No
Superiority or Other
Secondary
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)
Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)
Posted
Mean
Standard Deviation
mm Hg
baseline and week 6
ID
Title
Description
OG000
Low Dose
Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
OG001
Medium Dose
Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
OG002
High Dose
Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
Units
Counts
Participants
OG000
Secondary
Change From End of Period 1 (Week 6) in Mean Sitting Systolic Blood Pressure (MSSBP) to End of Placebo-controlled Withdrawal Period (Week 8)
Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)
Posted
Mean
Standard Deviation
mm Hg
week 6 and week 8
ID
Title
Description
OG000
Valsartan
pooled across all dosage levels
OG001
Placebo
Units
Counts
Participants
OG00035
Secondary
Change From End of Period 1 (Week 6) in Mean Sitting Diastolic Blood Pressure (MSDBP) to End of Placebo-controlled Withdrawal Period (Week 8)
Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)
Posted
Mean
Standard Deviation
mm Hg
week 6 and week 8
ID
Title
Description
OG000
Valsartan
pooled across all dosage levels
OG001
Placebo
Units
Counts
Participants
OG00035
Time Frame
Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Low Dose in Both Periods
Valsartan 0.25 mg/kg in both periods
1
15
8
15
EG001
Low Dose, Then Placebo
Valsartan 0.25 mg/kg, then Placebo
0
15
10
15
EG002
Medium Dose in Both Periods
Valsartan 1.0 mg/kg in both periods
0
6
3
6
EG003
Medium Dose, Then Placebo
Valsartan 1.0 mg/kg, then Placebo
1
8
4
8
EG004
High Dose in Both Periods
Valsartan 4.0 mg/kg in both periods
0
15
9
15
EG005
High Dose, Then Placebo
Valsartan 4.0 mg/kg, then Placebo
2
15
11
15
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Enteritis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG0030 affected8 at risk
EG0040 affected15 at risk
EG0051 affected15 at risk
Gastritis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG0030 affected8 at risk
EG0040 affected15 at risk
EG0051 affected15 at risk
Otorrhoea
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected15 at risk
EG0012 affected15 at risk
EG0020 affected6 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0003 affected15 at risk
EG0010 affected15 at risk
EG0021 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Allergy to arthropod bite
Immune system disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Acute tonsillitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected15 at risk
EG0011 affected15 at risk
EG0020 affected6 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected6 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Impetigo
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected15 at risk
EG0011 affected15 at risk
EG0021 affected6 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected6 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected6 at risk
EG003
Scarlet fever
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected15 at risk
EG0013 affected15 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Varicella
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected6 at risk
EG003
Asthmatic crisis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Increased upper airway secretion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.