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Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure (ASTRONAUT)

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ClinicalTrials.gov Identifier: NCT00894387
Recruitment Status : Completed
First Posted : May 7, 2009
Results First Posted : October 10, 2013
Last Update Posted : November 7, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Acute Decompensated Heart Failure
Congestive Heart Failure
Interventions Drug: Aliskiren
Drug: Placebo
Enrollment 1639
Recruitment Details  
Pre-assignment Details

Of the 2134 screened patients (including

1 patient who was screened twice), 1639 patients were randomized.

Arm/Group Title Aliskiren Placebo
Hide Arm/Group Description Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy. Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
Period Title: Overall Study
Started 821 [1] 818
Safety Set 808 810
Full Analysis Set 808 807
Completed Primary Efficacy Phase (6 m) 717 707
Completed Secondary Efficacy Phase (12m) 654 640
Completed 646 [2] 643
Not Completed 175 175
Reason Not Completed
Adverse Event             44             45
Abnormal Laboratory values             2             2
Unsatisfactory therapeutic effect             0             1
Lost to Follow-up             3             5
Administrative problems             2             2
Death             77             76
Protocol Deviation             4             0
Patient's request             25             30
Other (Missing)             5             3
Mis-randomized             13             9
GCP non-compliance             0             2
[1]
"Started" indicates all randomized patients
[2]
"Completed" indicates patients whose treatment duration completed as per protocol
Arm/Group Title Aliskiren Placebo Total
Hide Arm/Group Description Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy. Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren. Total of all reporting groups
Overall Number of Baseline Participants 808 807 1615
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 808 participants 807 participants 1615 participants
64.7  (12.44) 64.5  (11.88) 64.6  (12.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 808 participants 807 participants 1615 participants
Female
171
  21.2%
197
  24.4%
368
  22.8%
Male
637
  78.8%
610
  75.6%
1247
  77.2%
1.Primary Outcome
Title Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months
Hide Description Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization). The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug.
Arm/Group Title Aliskiren Placebo
Hide Arm/Group Description:
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
Overall Number of Participants Analyzed 808 807
Measure Type: Number
Unit of Measure: Participants
Primary Composite Endpoint 201 214
Cardiovascular death 77 85
Heart faliure re-hospitalization 153 166
2.Secondary Outcome
Title Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months
Hide Description Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 12 months of randomization was the key secondary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 395 (394 days from randomization). The secondary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 12 months.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug.
Arm/Group Title Aliskiren Placebo
Hide Arm/Group Description:
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
Overall Number of Participants Analyzed 808 807
Measure Type: Number
Unit of Measure: Participants
Secondary Composite Endpoint 283 301
Cardiovascular death 126 137
Heart faliure re-hospitalization 212 224
3.Secondary Outcome
Title Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months
Hide Description Symptom reduction and reduction in physical limitations was assessed using the clinical summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a self-administered questionnaire and contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Health-Related Quality of Life (QoL), including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Each scale score was calculated as the mean of its item scores and transformed to a 0–100 scale, with higher score indicating higher level of functioning. A score of 100 represents perfect health whereas a score of 0 represents death. A positive change in score from baseline indicates an improvement.
Time Frame Baseline, 1 months, 6 months and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized patients who had taken at least one dose of drug. 'n' in each category indicates patients with assessable data both at baseline and corresponding time points.
Arm/Group Title Aliskiren Placebo
Hide Arm/Group Description:
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
Overall Number of Participants Analyzed 808 807
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1 Month (n= 574, 571) 24.13  (0.903) 23.58  (0.908)
6 Months (n= 485, 474) 26.54  (1.004) 24.51  (1.016)
12 Months (n= 241, 230) 24.82  (1.268) 24.70  (1.291)
4.Secondary Outcome
Title Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
Hide Description A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized patients who had taken at least one dose of drug.
Arm/Group Title Aliskiren Placebo
Hide Arm/Group Description:
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
Overall Number of Participants Analyzed 808 807
Measure Type: Number
Unit of Measure: Participants
Cardiovascular event 209 233
Cardiovascular death 77 85
Heart faliure re-hospitalization 153 166
All-cause myocardial infarction 14 23
Fatal myocardial infarction 2 6
Non-fatal myocardial infarction 12 22
All-cause stroke 13 22
Fatal stroke 6 4
Non-fatal stroke 13 22
Resuscitated sudden death 3 8
5.Secondary Outcome
Title Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full ananlysis set included all randomized patients who had at least one dose of study drug.
Arm/Group Title Aliskiren Placebo
Hide Arm/Group Description:
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
Overall Number of Participants Analyzed 808 807
Measure Type: Number
Unit of Measure: Participants
144 148
6.Secondary Outcome
Title Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months
Hide Description The reported Least square means, and Confidential Interval were from a repeated measures model on log transformed NT-proBNP data containing treatment, visit, and region as factors, log baseline NT-proBNP as a continuous covariate and treatment by visit and visit by log baseline NT-proBNP as interaction terms.
Time Frame Baseline, 1 month, 6 months and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized patients who had taken at least one dose of study drug. 'n' in each category indicates patients with assessable date at baseline and each corresponding time point.
Arm/Group Title Aliskiren Placebo
Hide Arm/Group Description:
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
Overall Number of Participants Analyzed 808 807
Least Squares Mean (95% Confidence Interval)
Unit of Measure: pg/mL
Month 1 (n= 669, 675)
0.86
(0.81 to 0.91)
0.95
(0.90 to 1.00)
Month 6 (n= 569, 556)
0.64
(0.59 to 0.70)
0.76
(0.70 to 0.82)
Month 12 (n=447, 425)
0.62
(0.56 to 0.68)
0.74
(0.67 to 0.82)
7.Secondary Outcome
Title Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
Hide Description A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized patients who had taken at least one dose of study drug.
Arm/Group Title Aliskiren Placebo
Hide Arm/Group Description:
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
Overall Number of Participants Analyzed 808 807
Measure Type: Number
Unit of Measure: Participants
Cardiovascular event 293 321
Cardiovascular death 126 137
Heart faliure re-hospitalization 212 224
All-cause myocardial infarction 18 38
Fatal myocardial infarction 4 12
Non-fatal myocardial infarction 16 36
All-cause stroke 18 27
Fatal stroke 6 7
Non-fatal stroke 18 27
Resuscitated sudden death 5 10
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aliskiren Placebo
Hide Arm/Group Description Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy. Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
All-Cause Mortality
Aliskiren Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aliskiren Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   421/808 (52.10%)   435/810 (53.70%) 
Blood and lymphatic system disorders     
Anaemia  1  6/808 (0.74%)  5/810 (0.62%) 
Haemorrhagic disorder  1  1/808 (0.12%)  0/810 (0.00%) 
Hilar lymphadenopathy  1  1/808 (0.12%)  0/810 (0.00%) 
Jaundice acholuric  1  0/808 (0.00%)  1/810 (0.12%) 
Leukocytosis  1  0/808 (0.00%)  1/810 (0.12%) 
Lymphadenopathy  1  1/808 (0.12%)  0/810 (0.00%) 
Splenic infarction  1  1/808 (0.12%)  0/810 (0.00%) 
Thrombocytopenia  1  0/808 (0.00%)  1/810 (0.12%) 
Cardiac disorders     
Acute coronary syndrome  1  3/808 (0.37%)  3/810 (0.37%) 
Acute left ventricular failure  1  1/808 (0.12%)  1/810 (0.12%) 
Acute myocardial infarction  1  9/808 (1.11%)  15/810 (1.85%) 
Angina pectoris  1  9/808 (1.11%)  10/810 (1.23%) 
Angina unstable  1  7/808 (0.87%)  6/810 (0.74%) 
Aortic valve incompetence  1  1/808 (0.12%)  0/810 (0.00%) 
Arrhythmia  1  3/808 (0.37%)  3/810 (0.37%) 
Arrhythmia supraventricular  1  0/808 (0.00%)  1/810 (0.12%) 
Arteriospasm coronary  1  1/808 (0.12%)  0/810 (0.00%) 
Atrial fibrillation  1  14/808 (1.73%)  16/810 (1.98%) 
Atrial flutter  1  3/808 (0.37%)  2/810 (0.25%) 
Atrial tachycardia  1  1/808 (0.12%)  1/810 (0.12%) 
Atrioventricular block complete  1  2/808 (0.25%)  1/810 (0.12%) 
Bradyarrhythmia  1  0/808 (0.00%)  1/810 (0.12%) 
Bradycardia  1  1/808 (0.12%)  2/810 (0.25%) 
Cardiac arrest  1  11/808 (1.36%)  14/810 (1.73%) 
Cardiac failure  1  147/808 (18.19%)  155/810 (19.14%) 
Cardiac failure acute  1  58/808 (7.18%)  60/810 (7.41%) 
Cardiac failure chronic  1  50/808 (6.19%)  62/810 (7.65%) 
Cardiac failure congestive  1  21/808 (2.60%)  31/810 (3.83%) 
Cardiac tamponade  1  0/808 (0.00%)  1/810 (0.12%) 
Cardio-respiratory arrest  1  7/808 (0.87%)  3/810 (0.37%) 
Cardiogenic shock  1  7/808 (0.87%)  6/810 (0.74%) 
Cardiomyopathy  1  1/808 (0.12%)  0/810 (0.00%) 
Cardiopulmonary failure  1  2/808 (0.25%)  1/810 (0.12%) 
Cardiorenal syndrome  1  0/808 (0.00%)  1/810 (0.12%) 
Congestive cardiomyopathy  1  2/808 (0.25%)  2/810 (0.25%) 
Coronary artery disease  1  4/808 (0.50%)  2/810 (0.25%) 
Heart valve incompetence  1  0/808 (0.00%)  1/810 (0.12%) 
Ischaemic cardiomyopathy  1  0/808 (0.00%)  1/810 (0.12%) 
Left ventricular dysfunction  1  1/808 (0.12%)  0/810 (0.00%) 
Low cardiac output syndrome  1  1/808 (0.12%)  0/810 (0.00%) 
Myocardial fibrosis  1  1/808 (0.12%)  0/810 (0.00%) 
Myocardial infarction  1  11/808 (1.36%)  11/810 (1.36%) 
Myocardial ischaemia  1  3/808 (0.37%)  3/810 (0.37%) 
Palpitations  1  2/808 (0.25%)  2/810 (0.25%) 
Pericardial effusion  1  0/808 (0.00%)  1/810 (0.12%) 
Pulseless electrical activity  1  0/808 (0.00%)  2/810 (0.25%) 
Sick sinus syndrome  1  0/808 (0.00%)  1/810 (0.12%) 
Supraventricular tachycardia  1  0/808 (0.00%)  2/810 (0.25%) 
Tachyarrhythmia  1  1/808 (0.12%)  0/810 (0.00%) 
Tachycardia  1  3/808 (0.37%)  1/810 (0.12%) 
Ventricular arrhythmia  1  2/808 (0.25%)  4/810 (0.49%) 
Ventricular dysfunction  1  0/808 (0.00%)  1/810 (0.12%) 
Ventricular extrasystoles  1  1/808 (0.12%)  0/810 (0.00%) 
Ventricular fibrillation  1  4/808 (0.50%)  5/810 (0.62%) 
Ventricular tachycardia  1  10/808 (1.24%)  6/810 (0.74%) 
Ear and labyrinth disorders     
Vertigo  1  4/808 (0.50%)  2/810 (0.25%) 
Eye disorders     
Cataract  1  3/808 (0.37%)  0/810 (0.00%) 
Eye haemorrhage  1  0/808 (0.00%)  1/810 (0.12%) 
Glaucoma  1  1/808 (0.12%)  1/810 (0.12%) 
Retinal detachment  1  1/808 (0.12%)  0/810 (0.00%) 
Retinal haemorrhage  1  0/808 (0.00%)  1/810 (0.12%) 
Retinal vein occlusion  1  0/808 (0.00%)  1/810 (0.12%) 
Gastrointestinal disorders     
Abdominal pain  1  3/808 (0.37%)  4/810 (0.49%) 
Abdominal pain upper  1  0/808 (0.00%)  1/810 (0.12%) 
Ascites  1  0/808 (0.00%)  4/810 (0.49%) 
Colonic polyp  1  0/808 (0.00%)  1/810 (0.12%) 
Constipation  1  2/808 (0.25%)  0/810 (0.00%) 
Diarrhoea  1  2/808 (0.25%)  3/810 (0.37%) 
Diverticular perforation  1  0/808 (0.00%)  1/810 (0.12%) 
Diverticulum intestinal  1  0/808 (0.00%)  1/810 (0.12%) 
Duodenal ulcer haemorrhage  1  1/808 (0.12%)  0/810 (0.00%) 
Dyspepsia  1  2/808 (0.25%)  2/810 (0.25%) 
Enteritis  1  0/808 (0.00%)  1/810 (0.12%) 
Enterocolitis  1  1/808 (0.12%)  0/810 (0.00%) 
Gastritis  1  1/808 (0.12%)  0/810 (0.00%) 
Gastrointestinal haemorrhage  1  1/808 (0.12%)  5/810 (0.62%) 
Gingival bleeding  1  0/808 (0.00%)  1/810 (0.12%) 
Haemorrhoidal haemorrhage  1  0/808 (0.00%)  1/810 (0.12%) 
Haemorrhoids  1  0/808 (0.00%)  1/810 (0.12%) 
Hiatus hernia  1  1/808 (0.12%)  0/810 (0.00%) 
Inguinal hernia  1  1/808 (0.12%)  1/810 (0.12%) 
Intestinal obstruction  1  1/808 (0.12%)  0/810 (0.00%) 
Intestinal polyp  1  1/808 (0.12%)  0/810 (0.00%) 
Lower gastrointestinal haemorrhage  1  0/808 (0.00%)  2/810 (0.25%) 
Nausea  1  8/808 (0.99%)  3/810 (0.37%) 
Pancreatitis acute  1  0/808 (0.00%)  1/810 (0.12%) 
Rectal haemorrhage  1  0/808 (0.00%)  2/810 (0.25%) 
Small intestinal haemorrhage  1  0/808 (0.00%)  2/810 (0.25%) 
Small intestinal obstruction  1  1/808 (0.12%)  0/810 (0.00%) 
Tongue oedema  1  0/808 (0.00%)  1/810 (0.12%) 
Umbilical hernia, obstructive  1  1/808 (0.12%)  0/810 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/808 (0.12%)  0/810 (0.00%) 
Vomiting  1  5/808 (0.62%)  2/810 (0.25%) 
General disorders     
Asthenia  1  1/808 (0.12%)  3/810 (0.37%) 
Cardiac death  1  3/808 (0.37%)  3/810 (0.37%) 
Chest discomfort  1  1/808 (0.12%)  0/810 (0.00%) 
Chest pain  1  6/808 (0.74%)  0/810 (0.00%) 
Death  1  21/808 (2.60%)  25/810 (3.09%) 
Device breakage  1  0/808 (0.00%)  1/810 (0.12%) 
Device lead issue  1  1/808 (0.12%)  0/810 (0.00%) 
Device malfunction  1  1/808 (0.12%)  4/810 (0.49%) 
Drug intolerance  1  1/808 (0.12%)  0/810 (0.00%) 
Fatigue  1  2/808 (0.25%)  4/810 (0.49%) 
General physical health deterioration  1  2/808 (0.25%)  3/810 (0.37%) 
Generalised oedema  1  2/808 (0.25%)  2/810 (0.25%) 
Implant site haematoma  1  0/808 (0.00%)  1/810 (0.12%) 
Medical device complication  1  0/808 (0.00%)  1/810 (0.12%) 
Metaplasia  1  0/808 (0.00%)  1/810 (0.12%) 
Multi-organ failure  1  1/808 (0.12%)  3/810 (0.37%) 
Necrosis  1  1/808 (0.12%)  0/810 (0.00%) 
Non-cardiac chest pain  1  7/808 (0.87%)  1/810 (0.12%) 
Oedema peripheral  1  3/808 (0.37%)  6/810 (0.74%) 
Pain  1  0/808 (0.00%)  1/810 (0.12%) 
Pyrexia  1  2/808 (0.25%)  2/810 (0.25%) 
Soft tissue inflammation  1  1/808 (0.12%)  0/810 (0.00%) 
Stent malfunction  1  0/808 (0.00%)  1/810 (0.12%) 
Sudden cardiac death  1  5/808 (0.62%)  7/810 (0.86%) 
Sudden death  1  9/808 (1.11%)  5/810 (0.62%) 
Hepatobiliary disorders     
Acute hepatic failure  1  0/808 (0.00%)  1/810 (0.12%) 
Cholecystitis  1  2/808 (0.25%)  1/810 (0.12%) 
Cholelithiasis  1  1/808 (0.12%)  2/810 (0.25%) 
Hepatic cirrhosis  1  1/808 (0.12%)  0/810 (0.00%) 
Hepatic cyst  1  1/808 (0.12%)  0/810 (0.00%) 
Hepatitis  1  0/808 (0.00%)  1/810 (0.12%) 
Hepatitis cholestatic  1  0/808 (0.00%)  1/810 (0.12%) 
Hepatomegaly  1  1/808 (0.12%)  1/810 (0.12%) 
Hepatorenal syndrome  1  1/808 (0.12%)  0/810 (0.00%) 
Ischaemic hepatitis  1  0/808 (0.00%)  1/810 (0.12%) 
Immune system disorders     
Heart transplant rejection  1  1/808 (0.12%)  0/810 (0.00%) 
Infections and infestations     
Abscess limb  1  0/808 (0.00%)  1/810 (0.12%) 
Anal abscess  1  1/808 (0.12%)  0/810 (0.00%) 
Appendicitis  1  2/808 (0.25%)  0/810 (0.00%) 
Arthritis infective  1  0/808 (0.00%)  1/810 (0.12%) 
Bacteraemia  1  1/808 (0.12%)  1/810 (0.12%) 
Bronchiolitis  1  0/808 (0.00%)  1/810 (0.12%) 
Bronchitis  1  6/808 (0.74%)  6/810 (0.74%) 
Bronchitis bacterial  1  1/808 (0.12%)  0/810 (0.00%) 
Bronchopneumonia  1  3/808 (0.37%)  4/810 (0.49%) 
Cellulitis  1  1/808 (0.12%)  3/810 (0.37%) 
Citrobacter sepsis  1  0/808 (0.00%)  1/810 (0.12%) 
Clostridium difficile colitis  1  0/808 (0.00%)  1/810 (0.12%) 
Device related infection  1  1/808 (0.12%)  4/810 (0.49%) 
Endocarditis  1  0/808 (0.00%)  3/810 (0.37%) 
Erysipelas  1  2/808 (0.25%)  1/810 (0.12%) 
Gangrene  1  2/808 (0.25%)  3/810 (0.37%) 
Gastroenteritis  1  2/808 (0.25%)  3/810 (0.37%) 
Gastroenteritis norovirus  1  1/808 (0.12%)  1/810 (0.12%) 
Gastrointestinal viral infection  1  1/808 (0.12%)  0/810 (0.00%) 
Hepatitis B  1  1/808 (0.12%)  0/810 (0.00%) 
Infective exacerbation of chronic obstructive airways disease  1  1/808 (0.12%)  1/810 (0.12%) 
Influenza  1  0/808 (0.00%)  1/810 (0.12%) 
Liver abscess  1  1/808 (0.12%)  0/810 (0.00%) 
Lobar pneumonia  1  1/808 (0.12%)  2/810 (0.25%) 
Localised infection  1  1/808 (0.12%)  0/810 (0.00%) 
Lower respiratory tract infection  1  3/808 (0.37%)  2/810 (0.25%) 
Lung infection pseudomonal  1  0/808 (0.00%)  1/810 (0.12%) 
Orchitis  1  1/808 (0.12%)  0/810 (0.00%) 
Osteomyelitis  1  1/808 (0.12%)  2/810 (0.25%) 
Osteomyelitis acute  1  1/808 (0.12%)  0/810 (0.00%) 
Paronychia  1  1/808 (0.12%)  0/810 (0.00%) 
Peritonitis  1  0/808 (0.00%)  1/810 (0.12%) 
Pneumonia  1  25/808 (3.09%)  27/810 (3.33%) 
Pneumonia legionella  1  0/808 (0.00%)  1/810 (0.12%) 
Postoperative wound infection  1  1/808 (0.12%)  2/810 (0.25%) 
Pseudomembranous colitis  1  2/808 (0.25%)  0/810 (0.00%) 
Pseudomonas bronchitis  1  0/808 (0.00%)  1/810 (0.12%) 
Pulmonary sepsis  1  1/808 (0.12%)  1/810 (0.12%) 
Respiratory tract infection  1  3/808 (0.37%)  2/810 (0.25%) 
Sepsis  1  8/808 (0.99%)  5/810 (0.62%) 
Septic shock  1  5/808 (0.62%)  5/810 (0.62%) 
Skin infection  1  0/808 (0.00%)  2/810 (0.25%) 
Staphylococcal sepsis  1  1/808 (0.12%)  1/810 (0.12%) 
Subacute endocarditis  1  0/808 (0.00%)  1/810 (0.12%) 
Upper respiratory tract infection  1  1/808 (0.12%)  4/810 (0.49%) 
Urinary tract infection  1  4/808 (0.50%)  5/810 (0.62%) 
Urosepsis  1  0/808 (0.00%)  1/810 (0.12%) 
Viral infection  1  1/808 (0.12%)  0/810 (0.00%) 
Wound infection pseudomonas  1  1/808 (0.12%)  0/810 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  1/808 (0.12%)  0/810 (0.00%) 
Ankle fracture  1  1/808 (0.12%)  0/810 (0.00%) 
Brain herniation  1  0/808 (0.00%)  1/810 (0.12%) 
Contusion  1  1/808 (0.12%)  0/810 (0.00%) 
Dermatitis artefacta  1  1/808 (0.12%)  0/810 (0.00%) 
Electric shock  1  1/808 (0.12%)  0/810 (0.00%) 
Extradural haematoma  1  1/808 (0.12%)  0/810 (0.00%) 
Facial bones fracture  1  0/808 (0.00%)  1/810 (0.12%) 
Fall  1  0/808 (0.00%)  3/810 (0.37%) 
Femoral neck fracture  1  1/808 (0.12%)  0/810 (0.00%) 
Femur fracture  1  4/808 (0.50%)  1/810 (0.12%) 
Foot fracture  1  0/808 (0.00%)  1/810 (0.12%) 
Hand fracture  1  0/808 (0.00%)  1/810 (0.12%) 
Head injury  1  1/808 (0.12%)  0/810 (0.00%) 
Hip fracture  1  1/808 (0.12%)  2/810 (0.25%) 
Humerus fracture  1  2/808 (0.25%)  1/810 (0.12%) 
In-stent arterial restenosis  1  0/808 (0.00%)  1/810 (0.12%) 
Laceration  1  1/808 (0.12%)  0/810 (0.00%) 
Lower limb fracture  1  0/808 (0.00%)  1/810 (0.12%) 
Optic nerve injury  1  0/808 (0.00%)  1/810 (0.12%) 
Pelvic fracture  1  1/808 (0.12%)  1/810 (0.12%) 
Pneumothorax traumatic  1  0/808 (0.00%)  1/810 (0.12%) 
Post procedural haematoma  1  1/808 (0.12%)  0/810 (0.00%) 
Procedural haemorrhage  1  1/808 (0.12%)  0/810 (0.00%) 
Pubis fracture  1  1/808 (0.12%)  0/810 (0.00%) 
Rib fracture  1  0/808 (0.00%)  1/810 (0.12%) 
Road traffic accident  1  0/808 (0.00%)  1/810 (0.12%) 
Spinal compression fracture  1  1/808 (0.12%)  0/810 (0.00%) 
Splenic rupture  1  1/808 (0.12%)  0/810 (0.00%) 
Subcutaneous haematoma  1  1/808 (0.12%)  1/810 (0.12%) 
Subdural haematoma  1  2/808 (0.25%)  0/810 (0.00%) 
Thermal burn  1  1/808 (0.12%)  0/810 (0.00%) 
Tongue injury  1  0/808 (0.00%)  1/810 (0.12%) 
Toxicity to various agents  1  2/808 (0.25%)  1/810 (0.12%) 
Traumatic haematoma  1  0/808 (0.00%)  1/810 (0.12%) 
Vascular graft occlusion  1  0/808 (0.00%)  2/810 (0.25%) 
Vascular graft thrombosis  1  0/808 (0.00%)  1/810 (0.12%) 
Wound necrosis  1  0/808 (0.00%)  1/810 (0.12%) 
Investigations     
Activated partial thromboplastin time prolonged  1  0/808 (0.00%)  1/810 (0.12%) 
Anticoagulation drug level above therapeutic  1  1/808 (0.12%)  1/810 (0.12%) 
Blood creatinine increased  1  3/808 (0.37%)  1/810 (0.12%) 
Blood osmolarity decreased  1  0/808 (0.00%)  1/810 (0.12%) 
Blood potassium increased  1  0/808 (0.00%)  1/810 (0.12%) 
Coagulation test abnormal  1  0/808 (0.00%)  1/810 (0.12%) 
Ejection fraction decreased  1  0/808 (0.00%)  1/810 (0.12%) 
Haemoglobin decreased  1  1/808 (0.12%)  0/810 (0.00%) 
International normalised ratio increased  1  2/808 (0.25%)  1/810 (0.12%) 
Renal function test abnormal  1  1/808 (0.12%)  0/810 (0.00%) 
Transaminases increased  1  0/808 (0.00%)  1/810 (0.12%) 
Urine output decreased  1  0/808 (0.00%)  3/810 (0.37%) 
Weight increased  1  1/808 (0.12%)  3/810 (0.37%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/808 (0.12%)  0/810 (0.00%) 
Dehydration  1  3/808 (0.37%)  4/810 (0.49%) 
Diabetes mellitus  1  1/808 (0.12%)  3/810 (0.37%) 
Diabetes mellitus inadequate control  1  3/808 (0.37%)  3/810 (0.37%) 
Diabetic ketoacidosis  1  1/808 (0.12%)  0/810 (0.00%) 
Electrolyte imbalance  1  0/808 (0.00%)  1/810 (0.12%) 
Failure to thrive  1  1/808 (0.12%)  0/810 (0.00%) 
Fluid intake reduced  1  1/808 (0.12%)  0/810 (0.00%) 
Fluid overload  1  1/808 (0.12%)  1/810 (0.12%) 
Gout  1  2/808 (0.25%)  3/810 (0.37%) 
Hyperglycaemia  1  2/808 (0.25%)  3/810 (0.37%) 
Hyperkalaemia  1  12/808 (1.49%)  12/810 (1.48%) 
Hyperosmolar state  1  0/808 (0.00%)  1/810 (0.12%) 
Hypervolaemia  1  0/808 (0.00%)  1/810 (0.12%) 
Hypocholesterolaemia  1  0/808 (0.00%)  1/810 (0.12%) 
Hypoglycaemia  1  7/808 (0.87%)  2/810 (0.25%) 
Hypokalaemia  1  6/808 (0.74%)  6/810 (0.74%) 
Hyponatraemia  1  4/808 (0.50%)  5/810 (0.62%) 
Hypovolaemia  1  0/808 (0.00%)  1/810 (0.12%) 
Type 2 diabetes mellitus  1  0/808 (0.00%)  1/810 (0.12%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/808 (0.12%)  0/810 (0.00%) 
Arthritis  1  1/808 (0.12%)  0/810 (0.00%) 
Back pain  1  1/808 (0.12%)  2/810 (0.25%) 
Bursitis  1  1/808 (0.12%)  0/810 (0.00%) 
Costochondritis  1  1/808 (0.12%)  0/810 (0.00%) 
Fasciitis  1  0/808 (0.00%)  1/810 (0.12%) 
Flank pain  1  1/808 (0.12%)  1/810 (0.12%) 
Intervertebral disc protrusion  1  0/808 (0.00%)  1/810 (0.12%) 
Joint effusion  1  1/808 (0.12%)  0/810 (0.00%) 
Muscle haemorrhage  1  0/808 (0.00%)  1/810 (0.12%) 
Muscular weakness  1  1/808 (0.12%)  0/810 (0.00%) 
Musculoskeletal chest pain  1  2/808 (0.25%)  2/810 (0.25%) 
Pain in extremity  1  2/808 (0.25%)  1/810 (0.12%) 
Rotator cuff syndrome  1  0/808 (0.00%)  1/810 (0.12%) 
Soft tissue necrosis  1  1/808 (0.12%)  1/810 (0.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign bone neoplasm  1  0/808 (0.00%)  1/810 (0.12%) 
Bladder neoplasm  1  1/808 (0.12%)  0/810 (0.00%) 
Bronchial carcinoma  1  0/808 (0.00%)  1/810 (0.12%) 
Choroid melanoma  1  0/808 (0.00%)  1/810 (0.12%) 
Chronic lymphocytic leukaemia  1  1/808 (0.12%)  1/810 (0.12%) 
Colon cancer  1  2/808 (0.25%)  1/810 (0.12%) 
Colorectal cancer  1  1/808 (0.12%)  0/810 (0.00%) 
Hepatic neoplasm  1  1/808 (0.12%)  0/810 (0.00%) 
Hepatobiliary neoplasm  1  1/808 (0.12%)  0/810 (0.00%) 
Lipoma  1  0/808 (0.00%)  1/810 (0.12%) 
Liposarcoma  1  0/808 (0.00%)  1/810 (0.12%) 
Lung adenocarcinoma  1  1/808 (0.12%)  0/810 (0.00%) 
Lung neoplasm malignant  1  1/808 (0.12%)  0/810 (0.00%) 
Lung squamous cell carcinoma stage unspecified  1  1/808 (0.12%)  0/810 (0.00%) 
Multiple myeloma  1  1/808 (0.12%)  0/810 (0.00%) 
Non-small cell lung cancer metastatic  1  0/808 (0.00%)  1/810 (0.12%) 
Oesophageal neoplasm  1  0/808 (0.00%)  1/810 (0.12%) 
Ovarian cancer  1  0/808 (0.00%)  1/810 (0.12%) 
Prostate cancer  1  1/808 (0.12%)  3/810 (0.37%) 
Prostate cancer metastatic  1  1/808 (0.12%)  0/810 (0.00%) 
Renal cancer  1  1/808 (0.12%)  1/810 (0.12%) 
Uterine leiomyoma  1  1/808 (0.12%)  0/810 (0.00%) 
Nervous system disorders     
Anterior spinal artery syndrome  1  1/808 (0.12%)  0/810 (0.00%) 
Aphasia  1  0/808 (0.00%)  1/810 (0.12%) 
Burning sensation  1  1/808 (0.12%)  0/810 (0.00%) 
Cerebellar infarction  1  1/808 (0.12%)  1/810 (0.12%) 
Cerebral haematoma  1  1/808 (0.12%)  0/810 (0.00%) 
Cerebral infarction  1  1/808 (0.12%)  1/810 (0.12%) 
Cerebral ischaemia  1  0/808 (0.00%)  1/810 (0.12%) 
Cerebrovascular accident  1  9/808 (1.11%)  15/810 (1.85%) 
Coma  1  1/808 (0.12%)  0/810 (0.00%) 
Convulsion  1  0/808 (0.00%)  1/810 (0.12%) 
Diabetic hyperglycaemic coma  1  0/808 (0.00%)  1/810 (0.12%) 
Diabetic neuropathy  1  1/808 (0.12%)  0/810 (0.00%) 
Dizziness  1  4/808 (0.50%)  0/810 (0.00%) 
Dysarthria  1  1/808 (0.12%)  0/810 (0.00%) 
Embolic stroke  1  2/808 (0.25%)  0/810 (0.00%) 
Epilepsy  1  2/808 (0.25%)  0/810 (0.00%) 
Haemorrhagic stroke  1  1/808 (0.12%)  0/810 (0.00%) 
Hemiparesis  1  0/808 (0.00%)  3/810 (0.37%) 
Hypokinesia  1  1/808 (0.12%)  1/810 (0.12%) 
Intracranial haematoma  1  1/808 (0.12%)  0/810 (0.00%) 
Ischaemic stroke  1  5/808 (0.62%)  9/810 (1.11%) 
Loss of consciousness  1  1/808 (0.12%)  0/810 (0.00%) 
Metabolic encephalopathy  1  1/808 (0.12%)  0/810 (0.00%) 
Myasthenia gravis  1  1/808 (0.12%)  0/810 (0.00%) 
Myasthenia gravis crisis  1  1/808 (0.12%)  0/810 (0.00%) 
Neuropathy peripheral  1  1/808 (0.12%)  0/810 (0.00%) 
Presyncope  1  3/808 (0.37%)  4/810 (0.49%) 
Sensory disturbance  1  1/808 (0.12%)  1/810 (0.12%) 
Somnolence  1  2/808 (0.25%)  1/810 (0.12%) 
Subarachnoid haemorrhage  1  0/808 (0.00%)  2/810 (0.25%) 
Syncope  1  11/808 (1.36%)  13/810 (1.60%) 
Transient ischaemic attack  1  0/808 (0.00%)  3/810 (0.37%) 
Trigeminal neuralgia  1  1/808 (0.12%)  0/810 (0.00%) 
Unresponsive to stimuli  1  1/808 (0.12%)  0/810 (0.00%) 
Uraemic encephalopathy  1  1/808 (0.12%)  0/810 (0.00%) 
Vertebrobasilar insufficiency  1  0/808 (0.00%)  1/810 (0.12%) 
Psychiatric disorders     
Abnormal behaviour  1  1/808 (0.12%)  0/810 (0.00%) 
Alcohol abuse  1  1/808 (0.12%)  0/810 (0.00%) 
Anxiety  1  1/808 (0.12%)  0/810 (0.00%) 
Confusional state  1  2/808 (0.25%)  0/810 (0.00%) 
Depression  1  1/808 (0.12%)  1/810 (0.12%) 
Depression suicidal  1  1/808 (0.12%)  0/810 (0.00%) 
Disorientation  1  0/808 (0.00%)  1/810 (0.12%) 
Insomnia  1  0/808 (0.00%)  1/810 (0.12%) 
Mental status changes  1  0/808 (0.00%)  1/810 (0.12%) 
Restlessness  1  1/808 (0.12%)  1/810 (0.12%) 
Screaming  1  1/808 (0.12%)  0/810 (0.00%) 
Suicidal ideation  1  0/808 (0.00%)  1/810 (0.12%) 
Renal and urinary disorders     
Acute prerenal failure  1  1/808 (0.12%)  1/810 (0.12%) 
Anuria  1  0/808 (0.00%)  1/810 (0.12%) 
Bladder tamponade  1  1/808 (0.12%)  0/810 (0.00%) 
Haematuria  1  1/808 (0.12%)  0/810 (0.00%) 
Nephropathy  1  1/808 (0.12%)  0/810 (0.00%) 
Obstructive uropathy  1  0/808 (0.00%)  1/810 (0.12%) 
Polyuria  1  1/808 (0.12%)  0/810 (0.00%) 
Renal artery stenosis  1  1/808 (0.12%)  0/810 (0.00%) 
Renal artery thrombosis  1  0/808 (0.00%)  1/810 (0.12%) 
Renal failure  1  6/808 (0.74%)  8/810 (0.99%) 
Renal failure acute  1  20/808 (2.48%)  12/810 (1.48%) 
Renal failure chronic  1  1/808 (0.12%)  3/810 (0.37%) 
Renal impairment  1  5/808 (0.62%)  4/810 (0.49%) 
Urinary retention  1  0/808 (0.00%)  1/810 (0.12%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  2/808 (0.25%)  0/810 (0.00%) 
Menorrhagia  1  1/808 (0.12%)  0/810 (0.00%) 
Ovarian cyst  1  0/808 (0.00%)  1/810 (0.12%) 
Scrotal oedema  1  0/808 (0.00%)  1/810 (0.12%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  7/808 (0.87%)  4/810 (0.49%) 
Acute respiratory distress syndrome  1  1/808 (0.12%)  0/810 (0.00%) 
Acute respiratory failure  1  2/808 (0.25%)  1/810 (0.12%) 
Asthma  1  1/808 (0.12%)  0/810 (0.00%) 
Atelectasis  1  1/808 (0.12%)  0/810 (0.00%) 
Bronchiectasis  1  1/808 (0.12%)  0/810 (0.00%) 
Bronchitis chronic  1  0/808 (0.00%)  1/810 (0.12%) 
Bronchospasm  1  0/808 (0.00%)  1/810 (0.12%) 
Chronic obstructive pulmonary disease  1  13/808 (1.61%)  5/810 (0.62%) 
Cough  1  2/808 (0.25%)  2/810 (0.25%) 
Dyspnoea  1  20/808 (2.48%)  18/810 (2.22%) 
Dyspnoea at rest  1  0/808 (0.00%)  1/810 (0.12%) 
Dyspnoea paroxysmal nocturnal  1  0/808 (0.00%)  1/810 (0.12%) 
Epistaxis  1  0/808 (0.00%)  2/810 (0.25%) 
Haemoptysis  1  1/808 (0.12%)  3/810 (0.37%) 
Interstitial lung disease  1  0/808 (0.00%)  1/810 (0.12%) 
Lung disorder  1  0/808 (0.00%)  1/810 (0.12%) 
Obstructive airways disorder  1  0/808 (0.00%)  1/810 (0.12%) 
Pleural effusion  1  2/808 (0.25%)  2/810 (0.25%) 
Pleurisy  1  0/808 (0.00%)  1/810 (0.12%) 
Pneumonitis  1  1/808 (0.12%)  0/810 (0.00%) 
Pneumothorax  1  1/808 (0.12%)  0/810 (0.00%) 
Productive cough  1  1/808 (0.12%)  0/810 (0.00%) 
Pulmonary artery thrombosis  1  1/808 (0.12%)  0/810 (0.00%) 
Pulmonary congestion  1  1/808 (0.12%)  2/810 (0.25%) 
Pulmonary embolism  1  5/808 (0.62%)  5/810 (0.62%) 
Pulmonary oedema  1  4/808 (0.50%)  8/810 (0.99%) 
Rales  1  0/808 (0.00%)  1/810 (0.12%) 
Respiratory arrest  1  0/808 (0.00%)  1/810 (0.12%) 
Respiratory distress  1  0/808 (0.00%)  1/810 (0.12%) 
Respiratory failure  1  6/808 (0.74%)  5/810 (0.62%) 
Wheezing  1  1/808 (0.12%)  0/810 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis  1  0/808 (0.00%)  1/810 (0.12%) 
Diabetic foot  1  1/808 (0.12%)  2/810 (0.25%) 
Hyperhidrosis  1  2/808 (0.25%)  0/810 (0.00%) 
Skin exfoliation  1  0/808 (0.00%)  1/810 (0.12%) 
Skin necrosis  1  1/808 (0.12%)  1/810 (0.12%) 
Skin ulcer  1  1/808 (0.12%)  0/810 (0.00%) 
Skin ulcer haemorrhage  1  1/808 (0.12%)  0/810 (0.00%) 
Swelling face  1  0/808 (0.00%)  1/810 (0.12%) 
Surgical and medical procedures     
Gastric bypass  1  0/808 (0.00%)  1/810 (0.12%) 
Vascular disorders     
Circulatory collapse  1  0/808 (0.00%)  2/810 (0.25%) 
Deep vein thrombosis  1  1/808 (0.12%)  1/810 (0.12%) 
Extremity necrosis  1  1/808 (0.12%)  0/810 (0.00%) 
Haematoma  1  1/808 (0.12%)  1/810 (0.12%) 
Hypertension  1  2/808 (0.25%)  3/810 (0.37%) 
Hypertensive crisis  1  1/808 (0.12%)  3/810 (0.37%) 
Hypertensive emergency  1  0/808 (0.00%)  2/810 (0.25%) 
Hypotension  1  24/808 (2.97%)  16/810 (1.98%) 
Intra-abdominal haematoma  1  0/808 (0.00%)  1/810 (0.12%) 
Orthostatic hypotension  1  0/808 (0.00%)  2/810 (0.25%) 
Peripheral arterial occlusive disease  1  4/808 (0.50%)  2/810 (0.25%) 
Peripheral ischaemia  1  1/808 (0.12%)  0/810 (0.00%) 
Peripheral vascular disorder  1  2/808 (0.25%)  1/810 (0.12%) 
Phlebitis  1  1/808 (0.12%)  0/810 (0.00%) 
Venous haemorrhage  1  0/808 (0.00%)  1/810 (0.12%) 
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%
Aliskiren Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   367/808 (45.42%)   333/810 (41.11%) 
Gastrointestinal disorders     
Diarrhoea  1  49/808 (6.06%)  36/810 (4.44%) 
Metabolism and nutrition disorders     
Hyperkalaemia  1  155/808 (19.18%)  128/810 (15.80%) 
Hypokalaemia  1  42/808 (5.20%)  53/810 (6.54%) 
Nervous system disorders     
Dizziness  1  35/808 (4.33%)  43/810 (5.31%) 
Renal and urinary disorders     
Renal impairment  1  47/808 (5.82%)  33/810 (4.07%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  59/808 (7.30%)  53/810 (6.54%) 
Vascular disorders     
Hypotension  1  117/808 (14.48%)  83/810 (10.25%) 
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 or disclosure of trial results in their entirety.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00894387     History of Changes
Other Study ID Numbers: CSPP100A2368
2009-010236-18 ( EudraCT Number )
First Submitted: May 5, 2009
First Posted: May 7, 2009
Results First Submitted: August 2, 2013
Results First Posted: October 10, 2013
Last Update Posted: November 7, 2013