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Efficacy and Safety of Aliskiren and Valsartan Versus Placebo in Patients Stabilized Following an Acute Coronary Syndrome

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ClinicalTrials.gov Identifier: NCT00409578
Recruitment Status : Completed
First Posted : December 11, 2006
Results First Posted : February 2, 2011
Last Update Posted : April 19, 2011
Sponsor:
Collaborator:
The TIMI Study Group
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Post Acute Coronary Syndrome
Myocardial Ischemia
Interventions Drug: Placebo
Drug: Aliskiren 300 mg
Drug: Valsartan 320 mg
Drug: Aliskiren/valsartan 300/320 mg
Enrollment 1101
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Aliskiren 300 mg Valsartan 320 mg Aliskiren/Valsartan 300/320 mg
Hide Arm/Group Description Placebo tablets and capsules Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study. Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
Period Title: Overall Study
Started 280 271 269 281
Completed 228 201 215 214
Not Completed 52 70 54 67
Reason Not Completed
Adverse Event             27             37             25             33
Abnormal laboratory value(s)             2             2             2             4
Lack of Efficacy             0             0             0             2
Subject no longer requires study drug             0             0             0             1
Withdrawal by Subject             8             15             16             17
Lost to Follow-up             2             0             2             2
Administrative problems             8             9             2             4
Death             2             4             4             2
Protocol Violation             3             2             3             1
Missing             0             1             0             1
Arm/Group Title Placebo Aliskiren 300 mg Valsartan 320 mg Aliskiren/Valsartan 300/320 mg Total
Hide Arm/Group Description Placebo tablets and capsules Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study. Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study. Total of all reporting groups
Overall Number of Baseline Participants 280 271 269 281 1101
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 280 participants 271 participants 269 participants 281 participants 1101 participants
63  (11.8) 63  (11.7) 64  (11.6) 63  (11.1) 63  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 271 participants 269 participants 281 participants 1101 participants
Female
103
  36.8%
86
  31.7%
72
  26.8%
87
  31.0%
348
  31.6%
Male
177
  63.2%
185
  68.3%
197
  73.2%
194
  69.0%
753
  68.4%
1.Primary Outcome
Title Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8
Hide Description Blood samples for the measurement of NT-proBNP were collected, processed, and shipped to the TIMI Biomarker Core Laboratory, Boston MA for storage and analysis. The change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.
Arm/Group Title Placebo Aliskiren 300 mg Valsartan 320 mg Aliskiren/Valsartan 300/320 mg
Hide Arm/Group Description:
Placebo tablets and capsules
Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
Overall Number of Participants Analyzed 259 235 246 256
Geometric Mean (95% Confidence Interval)
Unit of Measure: pg/mL
0.582
(0.502 to 0.676)
0.563
(0.483 to 0.656)
0.614
(0.526 to 0.716)
0.635
(0.548 to 0.737)
2.Secondary Outcome
Title Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8
Hide Description Blood samples for the measurement of BNP were collected, processed, and shipped to the TIMI Biomarker Core Laboratory, Boston MA for storage and analysis. The change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.
Arm/Group Title Placebo Aliskiren 300 mg Valsartan 320 mg Aliskiren/Valsartan 300/320 mg
Hide Arm/Group Description:
Placebo tablets and capsules
Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
Overall Number of Participants Analyzed 252 229 237 252
Geometric Mean (95% Confidence Interval)
Unit of Measure: pg/mL
0.642
(0.535 to 0.770)
0.597
(0.495 to 0.720)
0.670
(0.554 to 0.810)
0.682
(0.568 to 0.818)
3.Secondary Outcome
Title Percentage of Patients With a Cardiac Event
Hide Description A cardiac event was defined as at least one of the following events: Cardiovascular death, recurrent myocardial infarction (MI), or hospitalization for congestive heart failure (CHF), all to be confirmed by adjudication.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.
Arm/Group Title Placebo Aliskiren 300 mg Valsartan 320 mg Aliskiren/Valsartan 300/320 mg
Hide Arm/Group Description:
Placebo tablets and capsules
Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
Overall Number of Participants Analyzed 278 268 268 278
Measure Type: Number
Unit of Measure: Percentage of patients
2.9 4.9 4.9 4.0
4.Secondary Outcome
Title Percentage of Patients With a Composite Clinical-biochemical Event
Hide Description A composite clinical-biochemical event was defined as at least one of the following events: cardiovascular death confirmed by adjudication, recurrent MI confirmed by adjudication, hospitalization for CHF confirmed by adjudication, and/or NT-proBNP => 200 pg/mL.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.
Arm/Group Title Placebo Aliskiren 300 mg Valsartan 320 mg Aliskiren/Valsartan 300/320 mg
Hide Arm/Group Description:
Placebo tablets and capsules
Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
Overall Number of Participants Analyzed 278 268 268 278
Measure Type: Number
Unit of Measure: Percentage of patients
79.5 73.5 77.2 75.2
Time Frame [Not Specified]
Adverse Event Reporting Description Safety set: All patients that received at least 1 dose of study drug. Missing values were not imputed. In the aliskiren group, 4 patients were excluded because they never received study drug. One patient who never received study drug was included in the safety set because he had a date for the end of study treatment on the study completion page.
 
Arm/Group Title Placebo Aliskiren 300 mg Valsartan 320 mg Aliskiren/Valsartan 300/320 mg
Hide Arm/Group Description Placebo tablets and capsules Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study. Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
All-Cause Mortality
Placebo Aliskiren 300 mg Valsartan 320 mg Aliskiren/Valsartan 300/320 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Aliskiren 300 mg Valsartan 320 mg Aliskiren/Valsartan 300/320 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   26/278 (9.35%)   39/264 (14.77%)   33/268 (12.31%)   46/279 (16.49%) 
Blood and lymphatic system disorders         
Anaemia  1  0/278 (0.00%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Idiopathic thrombocytopenic purpura  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Cardiac disorders         
Acute coronary syndrome  1  0/278 (0.00%)  3/264 (1.14%)  1/268 (0.37%)  1/279 (0.36%) 
Acute myocardial infarction  1  1/278 (0.36%)  4/264 (1.52%)  2/268 (0.75%)  0/279 (0.00%) 
Angina pectoris  1  2/278 (0.72%)  5/264 (1.89%)  3/268 (1.12%)  6/279 (2.15%) 
Angina unstable  1  1/278 (0.36%)  2/264 (0.76%)  1/268 (0.37%)  4/279 (1.43%) 
Atrial fibrillation  1  2/278 (0.72%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Atrioventricular block complete  1  0/278 (0.00%)  0/264 (0.00%)  1/268 (0.37%)  0/279 (0.00%) 
Cardiac failure  1  2/278 (0.72%)  1/264 (0.38%)  3/268 (1.12%)  2/279 (0.72%) 
Cardiac failure congestive  1  0/278 (0.00%)  1/264 (0.38%)  1/268 (0.37%)  0/279 (0.00%) 
Coronary artery disease  1  1/278 (0.36%)  2/264 (0.76%)  2/268 (0.75%)  0/279 (0.00%) 
Coronary artery occlusion  1  1/278 (0.36%)  0/264 (0.00%)  0/268 (0.00%)  0/279 (0.00%) 
Coronary artery stenosis  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Dressler's syndrome  1  1/278 (0.36%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Myocardial infarction  1  1/278 (0.36%)  2/264 (0.76%)  0/268 (0.00%)  5/279 (1.79%) 
Myocardial ischaemia  1  0/278 (0.00%)  1/264 (0.38%)  1/268 (0.37%)  4/279 (1.43%) 
Palpitations  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Pericarditis  1  0/278 (0.00%)  0/264 (0.00%)  1/268 (0.37%)  0/279 (0.00%) 
Postinfarction angina  1  1/278 (0.36%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Tachyarrhythmia  1  0/278 (0.00%)  0/264 (0.00%)  1/268 (0.37%)  0/279 (0.00%) 
Ventricular fibrillation  1  1/278 (0.36%)  0/264 (0.00%)  0/268 (0.00%)  0/279 (0.00%) 
Ear and labyrinth disorders         
Vertigo  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Vertigo positional  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Gastrointestinal disorders         
Diarrhoea  1  0/278 (0.00%)  0/264 (0.00%)  2/268 (0.75%)  0/279 (0.00%) 
Gastritis erosive  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Impaired gastric emptying  1  0/278 (0.00%)  0/264 (0.00%)  1/268 (0.37%)  0/279 (0.00%) 
Inguinal hernia  1  1/278 (0.36%)  0/264 (0.00%)  0/268 (0.00%)  0/279 (0.00%) 
Peptic ulcer  1  0/278 (0.00%)  0/264 (0.00%)  1/268 (0.37%)  0/279 (0.00%) 
General disorders         
Asthenia  1  0/278 (0.00%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Cardiac death  1  0/278 (0.00%)  0/264 (0.00%)  1/268 (0.37%)  1/279 (0.36%) 
Chest pain  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Malaise  1  0/278 (0.00%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Non-cardiac chest pain  1  2/278 (0.72%)  7/264 (2.65%)  2/268 (0.75%)  3/279 (1.08%) 
Sudden cardiac death  1  0/278 (0.00%)  2/264 (0.76%)  2/268 (0.75%)  0/279 (0.00%) 
Sudden death  1  1/278 (0.36%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Infections and infestations         
Bronchitis  1  0/278 (0.00%)  0/264 (0.00%)  2/268 (0.75%)  1/279 (0.36%) 
Cellulitis  1  0/278 (0.00%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Clostridium difficile colitis  1  0/278 (0.00%)  0/264 (0.00%)  1/268 (0.37%)  0/279 (0.00%) 
Diverticulitis  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Erysipelas  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Helicobacter gastritis  1  1/278 (0.36%)  0/264 (0.00%)  0/268 (0.00%)  0/279 (0.00%) 
Influenza  1  1/278 (0.36%)  0/264 (0.00%)  0/268 (0.00%)  0/279 (0.00%) 
Localised infection  1  1/278 (0.36%)  0/264 (0.00%)  0/268 (0.00%)  0/279 (0.00%) 
Pneumonia  1  1/278 (0.36%)  0/264 (0.00%)  3/268 (1.12%)  1/279 (0.36%) 
Postoperative wound infection  1  0/278 (0.00%)  1/264 (0.38%)  1/268 (0.37%)  0/279 (0.00%) 
Sepsis  1  0/278 (0.00%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Septic shock  1  0/278 (0.00%)  0/264 (0.00%)  1/268 (0.37%)  0/279 (0.00%) 
Viral infection  1  0/278 (0.00%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Injury, poisoning and procedural complications         
Arterial injury  1  0/278 (0.00%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Fall  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Pelvic fracture  1  1/278 (0.36%)  0/264 (0.00%)  0/268 (0.00%)  0/279 (0.00%) 
Subdural haematoma  1  1/278 (0.36%)  0/264 (0.00%)  0/268 (0.00%)  0/279 (0.00%) 
Thrombosis in device  1  0/278 (0.00%)  2/264 (0.76%)  0/268 (0.00%)  0/279 (0.00%) 
Tibia fracture  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Vascular pseudoaneurysm  1  0/278 (0.00%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Investigations         
ECG signs of myocardial ischaemia  1  1/278 (0.36%)  0/264 (0.00%)  0/268 (0.00%)  0/279 (0.00%) 
Heart rate decreased  1  1/278 (0.36%)  0/264 (0.00%)  0/268 (0.00%)  0/279 (0.00%) 
Metabolism and nutrition disorders         
Gout  1  1/278 (0.36%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Hypoglycaemic unconsciousness  1  0/278 (0.00%)  0/264 (0.00%)  1/268 (0.37%)  0/279 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Colon cancer  1  0/278 (0.00%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Hepatic cancer metastatic  1  0/278 (0.00%)  0/264 (0.00%)  1/268 (0.37%)  0/279 (0.00%) 
Nervous system disorders         
Cerebral haemorrhage  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Cerebrovascular accident  1  1/278 (0.36%)  0/264 (0.00%)  0/268 (0.00%)  0/279 (0.00%) 
Cervicobrachial syndrome  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Convulsion  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Presyncope  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Syncope  1  0/278 (0.00%)  0/264 (0.00%)  1/268 (0.37%)  2/279 (0.72%) 
Vertebrobasilar insufficiency  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Psychiatric disorders         
Anxiety  1  0/278 (0.00%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Chronic obstructive pulmonary disease  1  0/278 (0.00%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Dyspnoea  1  1/278 (0.36%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Epistaxis  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Pulmonary embolism  1  0/278 (0.00%)  0/264 (0.00%)  1/268 (0.37%)  1/279 (0.36%) 
Pulmonary oedema  1  1/278 (0.36%)  0/264 (0.00%)  2/268 (0.75%)  1/279 (0.36%) 
Vascular disorders         
Aortic aneurysm  1  0/278 (0.00%)  0/264 (0.00%)  1/268 (0.37%)  0/279 (0.00%) 
Arterial occlusive disease  1  0/278 (0.00%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Arterial stenosis  1  0/278 (0.00%)  0/264 (0.00%)  0/268 (0.00%)  1/279 (0.36%) 
Deep vein thrombosis  1  0/278 (0.00%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Femoral artery aneurysm  1  0/278 (0.00%)  1/264 (0.38%)  0/268 (0.00%)  1/279 (0.36%) 
Hypertension  1  1/278 (0.36%)  0/264 (0.00%)  0/268 (0.00%)  0/279 (0.00%) 
Hypertensive emergency  1  0/278 (0.00%)  1/264 (0.38%)  0/268 (0.00%)  0/279 (0.00%) 
Hypotension  1  0/278 (0.00%)  3/264 (1.14%)  0/268 (0.00%)  2/279 (0.72%) 
Ischaemia  1  0/278 (0.00%)  0/264 (0.00%)  1/268 (0.37%)  0/279 (0.00%) 
Orthostatic hypotension  1  0/278 (0.00%)  0/264 (0.00%)  1/268 (0.37%)  0/279 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Aliskiren 300 mg Valsartan 320 mg Aliskiren/Valsartan 300/320 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   64/278 (23.02%)   61/264 (23.11%)   51/268 (19.03%)   57/279 (20.43%) 
Cardiac disorders         
Angina pectoris  1  13/278 (4.68%)  9/264 (3.41%)  14/268 (5.22%)  8/279 (2.87%) 
Metabolism and nutrition disorders         
Hyperkalaemia  1  17/278 (6.12%)  16/264 (6.06%)  13/268 (4.85%)  13/279 (4.66%) 
Nervous system disorders         
Dizziness  1  15/278 (5.40%)  23/264 (8.71%)  13/268 (4.85%)  19/279 (6.81%) 
Headache  1  18/278 (6.47%)  10/264 (3.79%)  7/268 (2.61%)  10/279 (3.58%) 
Vascular disorders         
Orthostatic hypotension  1  14/278 (5.04%)  16/264 (6.06%)  12/268 (4.48%)  13/279 (4.66%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Layout table for additonal information
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00409578    
Other Study ID Numbers: CSPP100A2347
First Submitted: December 7, 2006
First Posted: December 11, 2006
Results First Submitted: January 11, 2011
Results First Posted: February 2, 2011
Last Update Posted: April 19, 2011