Severe Hypertension Grade 3 WHO classification (Mean Sitting Diastolic Blood Pressure (MSDBP) 110 mmHg and/or Mean Sitting Systolic Blood Pressure MSSBP 180 mmHg) 
Acetylsalicyclic acid (ASA) treatment >1g/day or regular use of Non steroidal anti-inflammatory drug (NSAIDs) 
Kidney disease not caused by diabetes or hypertension 
Serum potassium < 3.5 or > 5.1 mEq/L 
GFR < 40 ml/min/1.73m2 as measured by the MDRD formula 
Serum albumin < 2.0mg/dL 
History of hypertensive encephalopathy or cerebrovascular accident at any time prior to Visit1. 
Current diagnosis of heart failure (New York Heart Association (NYHA) Class II-IV) 
History of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1 
Second or third degree heart block without a pacemaker 
Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia 
Clinically significant valvular heart disease 
Type 1 diabetes mellitus 
Uncontrolled Type II diabetes mellitus (Hemaglobin subtype A1C (HbA1C) >11 %) 
History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years 
Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation. 
Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing. 
Significant illness within the two weeks prior to dosing. 
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following: 
History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection 
-Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1 Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Visit 1. 
Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase Evidence of hepatic disease, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt 
Current treatment with cholestyramine or cholestipol resins 
History of immunocompromise, including a positive HIV test result. 
History of a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. 
History of drug or alcohol abuse within the 12 months prior to dosing. 
Persons directly involved in the execution of this protocol. 
Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety 
History of noncompliance to medical regimens or unwillingness to comply with the study protocol 
Known or suspected contraindications to the study medications, including history of allergy to Angiotensin converting enzyme (ACE) inhibitors and/or to thiazide diuretics or other sulfonamide derived drug 
Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study 
Use of any prescription drug or over-the-counter (OTC) medication which is prohibited by the protocol. 
Patients who previously participated in any Aliskiren study. 
Pregnant or nursing woman. 
Other protocol-defined inclusion/exclusion criteria may apply       
    

NCT00461136_exc_T1
Condition
Severe Hypertension
NCT00461136_exc_T2
Measurement
Grade WHO classification
NCT00461136_exc_T3
Value
3
NCT00461136_exc_T4
Measurement
Mean Sitting Diastolic Blood Pressure (MSDBP)
NCT00461136_exc_T5
Value
110 mmHg
NCT00461136_exc_T6
Measurement
Mean Sitting Systolic Blood Pressure MSSBP
NCT00461136_exc_T7
Value
180 mmHg
NCT00461136_exc_T8
Scope
Mean Sitting Diastolic Blood Pressure (MSDBP) 110 mmHg and/or Mean Sitting Systolic Blood Pressure MSSBP 180 mmHg
NCT00461136_exc_T9
Procedure
Acetylsalicyclic acid (ASA) treatment
NCT00461136_exc_T10
Value
>1g/day
NCT00461136_exc_T11
Drug
Non steroidal anti-inflammatory drug (NSAIDs)
NCT00461136_exc_T12
Condition
Kidney disease
NCT00461136_exc_T13
Condition
diabetes
NCT00461136_exc_T14
Condition
hypertension
NCT00461136_exc_T15
Measurement
Serum potassium
NCT00461136_exc_T16
Value
< 3.5
NCT00461136_exc_T17
Value
> 5.1 mEq/L
NCT00461136_exc_T18
Measurement
GFR
NCT00461136_exc_T19
Value
< 40 ml/min/1.73m2
NCT00461136_exc_T20
Qualifier
MDRD formula
NCT00461136_exc_T21
Measurement
Serum albumin
NCT00461136_exc_T22
Value
< 2.0mg/dL
NCT00461136_exc_T23
Condition
hypertensive encephalopathy
NCT00461136_exc_T24
Condition
cerebrovascular accident
NCT00461136_exc_T25
Observation
History
NCT00461136_exc_T26
Temporal
any time prior
NCT00461136_exc_T27
Scope
hypertensive encephalopathy or cerebrovascular accident
NCT00461136_exc_T28
Condition
heart failure
NCT00461136_exc_T29
Measurement
New York Heart Association (NYHA) Class
NCT00461136_exc_T30
Value
II-IV
NCT00461136_exc_T31
Scope
New York Heart Association (NYHA) Class II-IV
NCT00461136_exc_T32
Condition
myocardial infarction
NCT00461136_exc_T33
Condition
unstable angina pectoris
NCT00461136_exc_T34
Condition
coronary bypass surgery
NCT00461136_exc_T35
Condition
percutaneous coronary intervention (PCI)
NCT00461136_exc_T36
Temporal
during the 6 months prior
NCT00461136_exc_T37
Observation
History
NCT00461136_exc_T38
Scope
myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (PCI)
NCT00461136_exc_T39
Condition
third degree heart block
NCT00461136_exc_T40
Condition
Second degree heart block
NCT00461136_exc_T41
Device
pacemaker
NCT00461136_exc_T42
Negation
without
NCT00461136_exc_T43
Scope
Second or third degree heart block
NCT00461136_exc_T44
Condition
arrhythmia
NCT00461136_exc_T45
Qualifier
potentially life threatening
NCT00461136_exc_T46
Condition
arrhythmia
NCT00461136_exc_T47
Qualifier
symptomatic
NCT00461136_exc_T48
Condition
valvular heart disease
NCT00461136_exc_T49
Condition
Type 1 diabetes mellitus
NCT00461136_exc_T50
Condition
Type II diabetes mellitus
NCT00461136_exc_T51
Measurement
Hemaglobin subtype A1C (HbA1C)
NCT00461136_exc_T52
Value
>11 %
NCT00461136_exc_T53
Qualifier
Uncontrolled
NCT00461136_exc_T54
Condition
malignancy
NCT00461136_exc_T55
Condition
leukemia
NCT00461136_exc_T56
Condition
lymphoma
NCT00461136_exc_T57
Condition
basal cell skin carcinoma
NCT00461136_exc_T58
Scope
leukemia and lymphoma
NCT00461136_exc_T59
Temporal
within the past five years
NCT00461136_exc_T60
Temporal
within 4 weeks prior to dosing
NCT00461136_exc_T61
Value
400 mL or more
NCT00461136_exc_T62
Temporal
within 8 weeks prior
NCT00461136_exc_T63
Procedure
Donation of blood
NCT00461136_exc_T64
Condition
loss of blood
NCT00461136_exc_T65
Condition
Significant illness
NCT00461136_exc_T66
Temporal
within the two weeks prior
NCT00461136_exc_T67
Condition
surgical condition
NCT00461136_exc_T68
Condition
medical condition
NCT00461136_exc_T69
Scope
surgical or medical condition
NCT00461136_exc_T70
Qualifier
alter the absorption, distribution, metabolism, or excretion of study drugs
NCT00461136_exc_T71
Observation
History
NCT00461136_exc_T72
Condition
major gastrointestinal tract surgery
NCT00461136_exc_T73
Procedure
gastrectomy
NCT00461136_exc_T74
Procedure
gastroenterostomy
NCT00461136_exc_T75
Procedure
bowel resection
NCT00461136_exc_T76
Scope
gastrectomy, gastroenterostomy, or bowel resection
NCT00461136_exc_T77
Condition
inflammatory bowel disease
NCT00461136_exc_T78
Temporal
during the 12 months prior
NCT00461136_exc_T79
Temporal
Currently active
NCT00461136_exc_T80
Temporal
Currently active
NCT00461136_exc_T81
Temporal
previously active
NCT00461136_exc_T82
Condition
gastritis
NCT00461136_exc_T83
Condition
duodenal
NCT00461136_exc_T84
Condition
gastric ulcers
NCT00461136_exc_T85
Condition
gastrointestinal bleeding
NCT00461136_exc_T86
Condition
rectal bleeding
NCT00461136_exc_T87
Temporal
during the 3 months prior
NCT00461136_exc_T88
Scope
gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding
NCT00461136_exc_T89
Condition
pancreatic injury
NCT00461136_exc_T90
Observation
history
NCT00461136_exc_T91
Condition
pancreatitis
NCT00461136_exc_T92
Measurement
pancreatic function
NCT00461136_exc_T93
Value
impaired
NCT00461136_exc_T94
Condition
pancreatic injury
NCT00461136_exc_T95
Measurement
lipase
NCT00461136_exc_T96
Value
abnormal
NCT00461136_exc_T97
Measurement
amylase
NCT00461136_exc_T98
Scope
abnormal lipase or amylase
NCT00461136_exc_T99
Condition
hepatic disease
NCT00461136_exc_T100
Observation
history
NCT00461136_exc_T101
Condition
hepatic encephalopathy
NCT00461136_exc_T102
Condition
esophageal varices
NCT00461136_exc_T103
Condition
portocaval shunt
NCT00461136_exc_T104
Observation
history
NCT00461136_exc_T105
Observation
history
NCT00461136_exc_T106
Scope
pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
NCT00461136_exc_T107
Drug
cholestyramine
NCT00461136_exc_T108
Drug
cholestipol resins
NCT00461136_exc_T109
Temporal
Current
NCT00461136_exc_T110
Condition
immunocompromise
NCT00461136_exc_T111
Observation
History
NCT00461136_exc_T112
Measurement
HIV test
NCT00461136_exc_T113
Value
positive
NCT00461136_exc_T114
Observation
History
NCT00461136_exc_T115
Measurement
Hepatitis B surface antigen (HBsAg) test
NCT00461136_exc_T116
Measurement
Hepatitis C test
NCT00461136_exc_T117
Value
positive
NCT00461136_exc_T118
Scope
positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test
NCT00461136_exc_T119
Observation
History
NCT00461136_exc_T120
Condition
drug abuse
NCT00461136_exc_T121
Condition
alcohol abuse
NCT00461136_exc_T122
Temporal
within the 12 months prior
NCT00461136_exc_T123
Scope
drug or alcohol abuse
NCT00461136_exc_T124
Condition
allergy
NCT00461136_exc_T125
Drug
Angiotensin converting enzyme (ACE) inhibitors
NCT00461136_exc_T126
Drug
thiazide diuretics
NCT00461136_exc_T127
Drug
sulfonamide derived drug
NCT00461136_exc_T128
Condition
contraindications
NCT00461136_exc_T129
Drug
study medications
NCT00461136_exc_T130
Drug
Aliskiren
NCT00461136_exc_T131
Condition
Pregnant
NCT00461136_exc_T132
Condition
nursing
NCT00461136_exc_T133
Person
woman
NCT00461136_exc_T135
Reference_point
dosing
NCT00461136_exc_T137
Condition
condition
NCT00461136_exc_T140
Qualifier
that would jeopardize the evaluation of efficacy
NCT00461136_exc_T141
Qualifier
that would jeopardize safety
NCT00461136_exc_T142
Scope
that would jeopardize the evaluation of efficacy safety
NCT00461136_exc_T143
Scope
in the opinion of the investigator or the Novartis medical monitor
NCT00461136_exc_T144
Observation
History of
NCT00461136_exc_T145
Observation
noncompliance to medical regimens
NCT00461136_exc_T146
Mood
unwillingness to
NCT00461136_exc_T148
Observation
history of
NCT00461136_exc_T149
Qualifier
other
NCT00461136_exc_T150
Condition
medical condition
NCT00461136_exc_T151
Condition
surgical condition
NCT00461136_exc_T153
Scope
surgical or medical condition
NCT00461136_exc_T154
Drug
prescription drug
NCT00461136_exc_T155
Drug
over-the-counter (OTC) medication
NCT00461136_exc_T156
Qualifier
prohibited by the protocol
NCT00461136_exc_T157
Scope
prescription drug or over-the-counter (OTC) medication
NCT00461136_exc_T158
Qualifier
place the patient at higher risk from his/her participation in the study
NCT00461136_exc_T159
Mood
likely to prevent the patient from
NCT00461136_exc_T161
Negation
prevent
NCT00461136_exc_T162
Temporal
previously
NCT00461136_exc_T164
Qualifier
Other
NCT00461136_exc_T165
Qualifier
protocol-defined