A Safety and Tolerability Study of the Combination of Ali... | NCT00386607 | Trialant
NCT00386607
Sponsor
Novartis
Status
Completed
Last Update Posted
Feb 10, 2014Estimated
Enrollment
601Actual
Phase
Phase 3
Conditions
Hypertension
Interventions
Aliskiren
Valsartan
Hydrochlorothiazide (HCTZ)
Countries
United States
Canada
Germany
Netherlands
Protocol Section
Identification Module
NCT ID
NCT00386607
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CSPV100A2301
Secondary IDs
ID
Type
Description
Link
CSPV100A2301E1
Brief Title
A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.
Official Title
A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg /Valsartan 320 mg in Patients With Essential Hypertension Followed by a 26 Week Open-label Extension to Assess the Long-term Safety and Tolerability of the Triple Combination of Aliskiren/Valsartan/Hydrochlorothiazide(HCTZ)
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jan 2014
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
Oct 2006
Primary Completion Date
Jul 2008Actual
Completion Date
Jul 2008Actual
First Submitted Date
Oct 10, 2006
First Submission Date that Met QC Criteria
Oct 10, 2006
First Posted Date
Oct 11, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 20, 2010
Results First Submitted that Met QC Criteria
Apr 7, 2011
Results First Posted Date
May 10, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 14, 2014
Last Update Posted Date
Feb 10, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
NovartisINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ).
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combination for 52-weeks, optional addition of Hydrochlorothiazide (HCTZ) 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (mean sitting Systolic Blood Pressure ≥ 140 and/or mean sitting Diastolic Blood Pressure ≥ 90 mmHg). The dose of Hydrochlorothiazide (HCTZ) 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
Drug: Aliskiren
Drug: Valsartan
Extension Treatment
Experimental
For patients entering into extension, those previously treated with Hydrochlorothiazide (HCTZ) 12.5 or 25 mg in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension. Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg.
The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the mean sitting Systolic Blood Pressure (msSBP) was ≥140 mmHg and/or the mean sitting Diastolic Blood Pressure (msDBP) was ≥90 mmHg for 2 consecutive visits.
Drug: Aliskiren
Drug: Valsartan
Drug: Hydrochlorothiazide (HCTZ)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Aliskiren
Drug
Aliskiren 300 mg
Core Treatment
Extension Treatment
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall Percentage of Patients With Adverse Events
Month 12
Overall Percentage of Patients With Adverse Events
adverse event data obtained from both the core study and the 6 month extension study.
Month 18
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Mean Sitting Diastolic Blood Pressure.
Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
Change From Baseline in Mean Sitting Systolic Blood Pressure.
Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria: -
Male and female outpatients 18 years of age and older.
For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg at Visit 1 and Visit 4
For previously treated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg after 2 to 4 weeks of washout (Visit 4)
Patients who were eligible and able to participate in the study and who consented to do so after the purpose and nature of the investigation had been clearly explained to them (written informed consent).
Chrysant SG, Murray AV, Hoppe UC, Dattani D, Patel S, Ritter S, Zhang J. Long-term safety and efficacy of aliskiren and valsartan combination with or without the addition of HCT in patients with hypertension. Curr Med Res Opin. 2010 Dec;26(12):2841-9. doi: 10.1185/03007995.2010.528282. Epub 2010 Nov 9.
See Also Links
Not provided
Available IPD Information
Not provided
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
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Core Treatment
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
Periods
Title
Milestones
Reasons Not Completed
Core
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
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
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Valsartan
Drug
Valsartan 320 mg
Core Treatment
Extension Treatment
Hydrochlorothiazide (HCTZ)
Drug
Hydrochlorothiazide (HCTZ) 12.5-25 mg
Extension Treatment
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
.Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
Change From Baseline in Mean Sitting Diastolic Blood Pressure
Baseline and Month 18
Change From Baseline in Mean Sitting Systolic Blood Pressure
Baseline and Month 18
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment
Month 18
Canada
Canada
Investigative Centers
Germany
Germany
Investigative Centers
Netherlands
Netherlands
FG001
Extension Treatment
For patients entering into extension, those previously treated with HCTZ (12.5 or 25 mg) in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension.
Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg.
The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the msSBP was ≥140 mmHg and/or the msDBP was ≥90 mmHg for 2 consecutive visits.
FG000601 subjects
FG0010 subjects
COMPLETED
FG000486 subjects
FG0010 subjects
NOT COMPLETED
FG000115 subjects
FG0010 subjects
Type
Comment
Reasons
Adverse Event
FG00040 subjects
FG0010 subjects
Abnormal laboratory value(s)
FG0003 subjects
FG0010 subjects
Unsatisfactory therapeutic effect
FG00023 subjects
FG0010 subjects
Condition no longer requires study drug
FG0004 subjects
FG0010 subjects
Patient withdrew consent
FG00015 subjects
FG0010 subjects
Lost to Follow-up
FG00023 subjects
FG0010 subjects
Administrative problems
FG0001 subjects
FG0010 subjects
Protocol Deviation
FG0006 subjects
FG0010 subjects
Extension
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG001162 subjects
COMPLETED
FG0000 subjects
FG001145 subjects
NOT COMPLETED
FG0000 subjects
FG00117 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0016 subjects
Abnormal laboratory value(s)
FG0000 subjects
FG001
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Core Treatment
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
Denominators
Units
Counts
Participants
BG000601
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
BG00055.0± 11.20
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000271
Male
BG000330
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
Overall Percentage of Patients With Adverse Events
Treated population: All patients who received at least one dose of Aliskiren/Valsartan
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
Units
Counts
Participants
OG000601
Title
Denominators
Categories
Title
Measurements
OG00076.2
Secondary
Change From Baseline in Mean Sitting Diastolic Blood Pressure.
Treated population
Posted
Mean
Standard Deviation
mmHg
Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
ID
Title
Description
OG000
Core Treatment
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Mean Sitting Systolic Blood Pressure.
Treated population
Posted
Mean
Standard Deviation
mmHg
Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54
ID
Title
Description
OG000
Core Treatment
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
Units
Counts
Participants
OG000
Secondary
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
Treated population
Posted
Number
Percentage of patients
.Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
ID
Title
Description
OG000
Core Treatment
Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Mean Sitting Diastolic Blood Pressure
Treated population
Posted
Mean
Standard Deviation
mmHg
Baseline and Month 18
ID
Title
Description
OG000
Extension Treatment
All patients receiving aliskiren / valsartan / HCTZ in extension study.
Units
Counts
Participants
OG000179
Title
Denominators
Categories
Primary
Overall Percentage of Patients With Adverse Events
adverse event data obtained from both the core study and the 6 month extension study.
Posted
Number
percentage of patients
Month 18
ID
Title
Description
OG000
Core and Extension Treatment - Aliskiren/Valsartan/HCTZ
All patients receiving aliskiren / valsartan / HCTZ during either core or extension study.
Units
Counts
Participants
OG000310
Title
Secondary
Change From Baseline in Mean Sitting Systolic Blood Pressure
Treated population
Posted
Mean
Standard Deviation
mmHg
Baseline and Month 18
ID
Title
Description
OG000
Extension Treatment
All patients receiving aliskiren / valsartan / HCTZ in extension study.
Units
Counts
Participants
OG000179
Title
Denominators
Categories
Secondary
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment
Treated population
Posted
Number
Percentage of patients
Month 18
ID
Title
Description
OG000
Extension Treatment
All patients receiving aliskiren / valsartan / HCTZ in extension study.
Units
Counts
Participants
OG000179
Title
Denominators
Categories
Time Frame
18 months
Description
All patients who received at least one dose of study medication.
Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg
Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg
3
306
47
306
EG004
Core and Extension: Aliskiren / Valsartan / HCTZ 25 mg
Core and Extension: Aliskiren/Valsartan/HCTZ 25 mg
6
137
26
137
EG005
Core and Extension: Total
Core and Extension: Total includes all study patients, treated with Aliskiren/Valsartan or Aliskiren//valsartan/HCTZ during core or extension.
26
601
251
601
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected601 at risk
EG0010 affected585 at risk
EG0021 affected601 at risk
EG0030 affected306 at risk
EG0040 affected137 at risk
EG0051 affected601 at risk
Angina pectoris
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected601 at risk
EG0010 affected585 at risk
EG0021 affected601 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Ventricular hypokinesia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Retinal vascular thrombosis
Eye disorders
MedDRA
Systematic Assessment
EG0001 affected601 at risk
EG0010 affected585 at risk
EG0021 affected601 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Generalised oedema
General disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0010 affected585 at risk
EG0020 affected601 at risk
EG003
Gallbladder disorder
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Appendicitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0010 affected585 at risk
EG0020 affected601 at risk
EG003
Hepatitis B
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0010 affected585 at risk
EG0020 affected601 at risk
EG003
Peritoneal abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0010 affected585 at risk
EG0020 affected601 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0010 affected585 at risk
EG0020 affected601 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Therapeutic agent toxicity
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0010 affected585 at risk
EG0020 affected601 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0010 affected585 at risk
EG0020 affected601 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0010 affected585 at risk
EG0020 affected601 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0010 affected585 at risk
EG0020 affected601 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0010 affected585 at risk
EG0020 affected601 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected601 at risk
EG0010 affected585 at risk
EG0021 affected601 at risk
EG003
Syncope
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Substance abuse
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0010 affected585 at risk
EG0020 affected601 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0010 affected585 at risk
EG0020 affected601 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Hypotension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected601 at risk
EG0011 affected585 at risk
EG0021 affected601 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0008 affected601 at risk
EG00127 affected585 at risk
EG00234 affected601 at risk
EG0039 affected306 at risk
EG0041 affected137 at risk
EG00542 affected601 at risk
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0003 affected601 at risk
EG00124 affected585 at risk
EG00227 affected601 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0006 affected601 at risk
EG00139 affected585 at risk
EG00243 affected601 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected601 at risk
EG00125 affected585 at risk
EG00228 affected601 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0004 affected601 at risk
EG00119 affected585 at risk
EG00221 affected601 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG00015 affected601 at risk
EG00139 affected585 at risk
EG00249 affected601 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG00016 affected601 at risk
EG00133 affected585 at risk
EG00245 affected601 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected601 at risk
EG00123 affected585 at risk
EG00224 affected601 at risk
EG003
Open label study with no comparator treatment/arm.
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.