Trial Outcomes & Findings for Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients (NCT NCT00853827)
NCT ID: NCT00853827
Last Updated: 2014-06-03
Results Overview
Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
613 participants
Primary outcome timeframe
Baseline, 104 weeks
Results posted on
2014-06-03
Participant Flow
Participant milestones
| Measure |
Aliskiren
Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
|
Placebo
Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
|
|---|---|---|
|
Single Blind Period (1 Week)
STARTED
|
652
|
0
|
|
Single Blind Period (1 Week)
COMPLETED
|
613
|
0
|
|
Single Blind Period (1 Week)
NOT COMPLETED
|
39
|
0
|
|
Double Blind Period (103 Weeks)
STARTED
|
305
|
308
|
|
Double Blind Period (103 Weeks)
Modified Full Analysis Set (mFAS)
|
225
|
233
|
|
Double Blind Period (103 Weeks)
COMPLETED
|
201
|
199
|
|
Double Blind Period (103 Weeks)
NOT COMPLETED
|
104
|
109
|
Reasons for withdrawal
| Measure |
Aliskiren
Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
|
Placebo
Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
|
|---|---|---|
|
Single Blind Period (1 Week)
Other
|
4
|
0
|
|
Single Blind Period (1 Week)
Adverse Event
|
9
|
0
|
|
Single Blind Period (1 Week)
Abnormal laboratory value
|
3
|
0
|
|
Single Blind Period (1 Week)
Abnormal test procedure result
|
1
|
0
|
|
Single Blind Period (1 Week)
Withdrawal by Subject
|
9
|
0
|
|
Single Blind Period (1 Week)
Lost to Follow-up
|
1
|
0
|
|
Single Blind Period (1 Week)
Protocol Violation
|
12
|
0
|
|
Double Blind Period (103 Weeks)
Adverse Event
|
25
|
14
|
|
Double Blind Period (103 Weeks)
Abnormal laboratory values
|
0
|
3
|
|
Double Blind Period (103 Weeks)
Lack of Efficacy
|
1
|
0
|
|
Double Blind Period (103 Weeks)
Patient's no longer requires study drug
|
3
|
1
|
|
Double Blind Period (103 Weeks)
Protocol Violation
|
2
|
1
|
|
Double Blind Period (103 Weeks)
Withdrawal by Subject
|
19
|
18
|
|
Double Blind Period (103 Weeks)
Lost to Follow-up
|
8
|
10
|
|
Double Blind Period (103 Weeks)
Administrative problems
|
45
|
56
|
|
Double Blind Period (103 Weeks)
Death
|
1
|
6
|
Baseline Characteristics
Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients
Baseline characteristics by cohort
| Measure |
Aliskiren
n=305 Participants
Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
|
Placebo
n=308 Participants
Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
|
Total
n=613 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 8.32 • n=7 Participants
|
59.7 years
STANDARD_DEVIATION 8.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
228 Participants
n=5 Participants
|
239 Participants
n=7 Participants
|
467 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 104 weeksPopulation: Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization. All patients who had a valid baseline and post baseline IVUS measurement and post-baseline IVUS measurement and at least ≥72 weeks of treatment were included in this analysis.
Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases
Outcome measures
| Measure |
Aliskiren
n=225 Participants
Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
|
Placebo
n=233 Participants
Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
|
|---|---|---|
|
Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment
|
-0.33 percentage of baseline
Standard Error 0.18
|
0.11 percentage of baseline
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline, 104 weeksPopulation: Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization. All patients who had a valid baseline and post baseline IVUS measurement and post-baseline IVUS measurement and at least ≥72 weeks of treatment were included in this analysis.
Change from baseline in normalized total atheroma volume (TAV) (mm\^3) for all matched slices of anatomically comparable segments of the target coronary artery were assess by IVUS after 104 weeks of treatment. calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases
Outcome measures
| Measure |
Aliskiren
n=225 Participants
Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
|
Placebo
n=233 Participants
Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
|
|---|---|---|
|
Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS
|
-4.11 mm^3
Standard Error 1.10
|
-2.07 mm^3
Standard Error 1.09
|
SECONDARY outcome
Timeframe: Baseline to endpoint (104 weeks)Population: Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization
Atheroma regression is defined as change from baseline to endpoint in PAV \<0 .
Outcome measures
| Measure |
Aliskiren
n=225 Participants
Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
|
Placebo
n=233 Participants
Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
|
|---|---|---|
|
Patients That Demonstrated Evidence of Atheroma Regression
|
128 Participants
|
114 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Safety - All patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received
overall safety and tolerability of aliskiren 300 mg compared to placebo in patients with CAD and BP in the pre-hypertensive (high normal) range with or without treatment for hypertension following 104 weeks of treatment. Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity.
Outcome measures
| Measure |
Aliskiren
n=305 Participants
Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
|
Placebo
n=308 Participants
Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
|
|---|---|---|
|
Number of Patients With Adverse Events, Serious Adverse Events, and Death
SAEs
|
76 Number of patients
|
97 Number of patients
|
|
Number of Patients With Adverse Events, Serious Adverse Events, and Death
AE
|
228 Number of patients
|
227 Number of patients
|
|
Number of Patients With Adverse Events, Serious Adverse Events, and Death
Death
|
1 Number of patients
|
6 Number of patients
|
Adverse Events
Aliskiren 300 mg
Serious events: 76 serious events
Other events: 186 other events
Deaths: 0 deaths
Placebo
Serious events: 97 serious events
Other events: 175 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aliskiren 300 mg
n=305 participants at risk
Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
|
Placebo
n=308 participants at risk
Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.33%
1/305
|
0.32%
1/308
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.33%
1/305
|
0.00%
0/308
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.33%
1/305
|
0.00%
0/308
|
|
Cardiac disorders
Acute coronary syndrome
|
0.33%
1/305
|
0.97%
3/308
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/305
|
0.65%
2/308
|
|
Cardiac disorders
Angina pectoris
|
2.0%
6/305
|
3.9%
12/308
|
|
Cardiac disorders
Angina unstable
|
2.0%
6/305
|
1.9%
6/308
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.33%
1/305
|
0.65%
2/308
|
|
Cardiac disorders
Atrial fibrillation
|
0.66%
2/305
|
0.65%
2/308
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/305
|
0.32%
1/308
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/305
|
0.32%
1/308
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/305
|
0.32%
1/308
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/305
|
0.32%
1/308
|
|
Cardiac disorders
Coronary artery disease
|
0.66%
2/305
|
1.6%
5/308
|
|
Cardiac disorders
Coronary artery occlusion
|
0.33%
1/305
|
0.65%
2/308
|
|
Cardiac disorders
Coronary artery stenosis
|
0.66%
2/305
|
1.6%
5/308
|
|
Cardiac disorders
Myocardial infarction
|
0.33%
1/305
|
0.65%
2/308
|
|
Cardiac disorders
Myocardial ischaemia
|
0.66%
2/305
|
0.65%
2/308
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/305
|
0.32%
1/308
|
|
Cardiac disorders
Tachycardia
|
0.33%
1/305
|
0.32%
1/308
|
|
Cardiac disorders
Ventricular fibrillation
|
0.33%
1/305
|
0.00%
0/308
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.33%
1/305
|
0.00%
0/308
|
|
Ear and labyrinth disorders
Deafness
|
0.33%
1/305
|
0.00%
0/308
|
|
Ear and labyrinth disorders
Tinnitus
|
0.33%
1/305
|
0.00%
0/308
|
|
Endocrine disorders
Hyperparathyroidism
|
0.33%
1/305
|
0.00%
0/308
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/305
|
0.32%
1/308
|
|
Eye disorders
Cataract
|
0.33%
1/305
|
0.00%
0/308
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/305
|
0.32%
1/308
|
|
Eye disorders
Visual impairment
|
0.33%
1/305
|
0.00%
0/308
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/305
|
0.32%
1/308
|
|
Gastrointestinal disorders
Abdominal pain
|
0.66%
2/305
|
0.00%
0/308
|
|
Gastrointestinal disorders
Diarrhoea
|
0.33%
1/305
|
0.00%
0/308
|
|
Gastrointestinal disorders
Dyspepsia
|
0.33%
1/305
|
0.00%
0/308
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/305
|
0.32%
1/308
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/305
|
0.32%
1/308
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/305
|
0.32%
1/308
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.33%
1/305
|
0.65%
2/308
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.33%
1/305
|
0.00%
0/308
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.33%
1/305
|
0.00%
0/308
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/305
|
0.32%
1/308
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/305
|
0.32%
1/308
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/305
|
0.32%
1/308
|
|
Gastrointestinal disorders
Melaena
|
0.33%
1/305
|
0.00%
0/308
|
|
Gastrointestinal disorders
Nausea
|
0.33%
1/305
|
0.00%
0/308
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.33%
1/305
|
0.00%
0/308
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/305
|
0.32%
1/308
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.33%
1/305
|
0.00%
0/308
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/305
|
0.32%
1/308
|
|
Gastrointestinal disorders
Vomiting
|
0.66%
2/305
|
0.00%
0/308
|
|
General disorders
Asthenia
|
0.00%
0/305
|
0.32%
1/308
|
|
General disorders
Catheter site haemorrhage
|
0.33%
1/305
|
0.00%
0/308
|
|
General disorders
Chest discomfort
|
0.33%
1/305
|
0.00%
0/308
|
|
General disorders
Chest pain
|
0.33%
1/305
|
0.65%
2/308
|
|
General disorders
Fatigue
|
0.66%
2/305
|
0.32%
1/308
|
|
General disorders
Multi-organ failure
|
0.00%
0/305
|
0.32%
1/308
|
|
General disorders
Non-cardiac chest pain
|
1.3%
4/305
|
1.3%
4/308
|
|
General disorders
Oedema peripheral
|
0.66%
2/305
|
0.00%
0/308
|
|
General disorders
Pyrexia
|
0.00%
0/305
|
0.32%
1/308
|
|
General disorders
Sudden cardiac death
|
0.00%
0/305
|
0.32%
1/308
|
|
General disorders
Sudden death
|
0.00%
0/305
|
0.32%
1/308
|
|
Hepatobiliary disorders
Cholecystitis
|
0.33%
1/305
|
0.32%
1/308
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.33%
1/305
|
0.00%
0/308
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/305
|
0.32%
1/308
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/305
|
0.32%
1/308
|
|
Infections and infestations
Cellulitis
|
0.66%
2/305
|
0.00%
0/308
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/305
|
0.65%
2/308
|
|
Infections and infestations
Enterocolitis infectious
|
0.33%
1/305
|
0.00%
0/308
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/305
|
0.65%
2/308
|
|
Infections and infestations
Liver abscess
|
0.00%
0/305
|
0.32%
1/308
|
|
Infections and infestations
Lobar pneumonia
|
0.33%
1/305
|
0.00%
0/308
|
|
Infections and infestations
Meningitis aseptic
|
0.33%
1/305
|
0.00%
0/308
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/305
|
0.32%
1/308
|
|
Infections and infestations
Pneumonia
|
0.66%
2/305
|
0.97%
3/308
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/305
|
0.32%
1/308
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/305
|
0.32%
1/308
|
|
Infections and infestations
Pyelonephritis acute
|
0.33%
1/305
|
0.00%
0/308
|
|
Infections and infestations
Sepsis
|
0.33%
1/305
|
0.65%
2/308
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/305
|
0.32%
1/308
|
|
Infections and infestations
Sweat gland infection
|
0.00%
0/305
|
0.32%
1/308
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/305
|
0.32%
1/308
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
0.66%
2/305
|
0.32%
1/308
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.33%
1/305
|
1.3%
4/308
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.33%
1/305
|
0.00%
0/308
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/305
|
0.32%
1/308
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/305
|
0.32%
1/308
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.33%
1/305
|
0.00%
0/308
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/305
|
0.32%
1/308
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/305
|
0.32%
1/308
|
|
Injury, poisoning and procedural complications
Overdose
|
0.66%
2/305
|
0.32%
1/308
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/305
|
0.32%
1/308
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/305
|
0.32%
1/308
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.33%
1/305
|
0.00%
0/308
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/305
|
0.32%
1/308
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/305
|
0.32%
1/308
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/305
|
0.65%
2/308
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/305
|
0.32%
1/308
|
|
Metabolism and nutrition disorders
Dehydration
|
0.33%
1/305
|
0.00%
0/308
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.66%
2/305
|
0.32%
1/308
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/305
|
0.32%
1/308
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/305
|
0.32%
1/308
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.33%
1/305
|
0.00%
0/308
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/305
|
0.32%
1/308
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/305
|
0.32%
1/308
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.33%
1/305
|
0.00%
0/308
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.33%
1/305
|
0.32%
1/308
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/305
|
0.32%
1/308
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/305
|
0.32%
1/308
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.66%
2/305
|
0.00%
0/308
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.33%
1/305
|
0.00%
0/308
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.33%
1/305
|
0.00%
0/308
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/305
|
0.32%
1/308
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.33%
1/305
|
0.00%
0/308
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/305
|
0.32%
1/308
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.66%
2/305
|
0.00%
0/308
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/305
|
0.32%
1/308
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.33%
1/305
|
0.00%
0/308
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/305
|
0.32%
1/308
|
|
Nervous system disorders
Cerebral ischaemia
|
0.33%
1/305
|
0.00%
0/308
|
|
Nervous system disorders
Cerebral microangiopathy
|
0.33%
1/305
|
0.00%
0/308
|
|
Nervous system disorders
Cerebrovascular accident
|
0.33%
1/305
|
0.65%
2/308
|
|
Nervous system disorders
Convulsion
|
0.66%
2/305
|
0.00%
0/308
|
|
Nervous system disorders
Headache
|
0.33%
1/305
|
0.65%
2/308
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/305
|
0.32%
1/308
|
|
Nervous system disorders
Paraesthesia
|
0.66%
2/305
|
0.00%
0/308
|
|
Nervous system disorders
Syncope
|
0.98%
3/305
|
0.32%
1/308
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/305
|
0.32%
1/308
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/305
|
0.32%
1/308
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/305
|
0.32%
1/308
|
|
Psychiatric disorders
Depression
|
0.33%
1/305
|
0.32%
1/308
|
|
Psychiatric disorders
Depression suicidal
|
0.33%
1/305
|
0.00%
0/308
|
|
Psychiatric disorders
Suicidal ideation
|
0.33%
1/305
|
0.00%
0/308
|
|
Psychiatric disorders
Suicide attempt
|
0.33%
1/305
|
0.00%
0/308
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/305
|
0.65%
2/308
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.33%
1/305
|
0.00%
0/308
|
|
Renal and urinary disorders
Renal failure
|
0.33%
1/305
|
0.00%
0/308
|
|
Renal and urinary disorders
Renal failure acute
|
0.33%
1/305
|
0.32%
1/308
|
|
Renal and urinary disorders
Urethral stenosis
|
0.33%
1/305
|
0.00%
0/308
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/305
|
0.32%
1/308
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/305
|
0.32%
1/308
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.33%
1/305
|
0.00%
0/308
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/305
|
0.32%
1/308
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.33%
1/305
|
0.00%
0/308
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.66%
2/305
|
0.00%
0/308
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic disorder
|
0.00%
0/305
|
0.32%
1/308
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.33%
1/305
|
0.32%
1/308
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/305
|
0.32%
1/308
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.33%
1/305
|
0.00%
0/308
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.33%
1/305
|
0.00%
0/308
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/305
|
0.32%
1/308
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.66%
2/305
|
0.00%
0/308
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/305
|
0.32%
1/308
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/305
|
0.32%
1/308
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/305
|
0.32%
1/308
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/305
|
0.32%
1/308
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.33%
1/305
|
0.00%
0/308
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/305
|
0.32%
1/308
|
|
Vascular disorders
Aortic stenosis
|
0.98%
3/305
|
0.00%
0/308
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/305
|
0.32%
1/308
|
|
Vascular disorders
Arteriosclerosis
|
0.33%
1/305
|
0.00%
0/308
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/305
|
0.32%
1/308
|
|
Vascular disorders
Hypotension
|
0.33%
1/305
|
0.00%
0/308
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/305
|
0.32%
1/308
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/305
|
0.32%
1/308
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/305
|
0.32%
1/308
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/305
|
0.32%
1/308
|
|
Vascular disorders
Reperfusion injury
|
0.33%
1/305
|
0.00%
0/308
|
Other adverse events
| Measure |
Aliskiren 300 mg
n=305 participants at risk
Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
|
Placebo
n=308 participants at risk
Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
6.9%
21/305
|
7.8%
24/308
|
|
Cardiac disorders
Palpitations
|
1.3%
4/305
|
2.6%
8/308
|
|
Gastrointestinal disorders
Constipation
|
2.6%
8/305
|
3.2%
10/308
|
|
Gastrointestinal disorders
Diarrhoea
|
6.6%
20/305
|
4.9%
15/308
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
5/305
|
2.6%
8/308
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.0%
9/305
|
1.6%
5/308
|
|
Gastrointestinal disorders
Nausea
|
4.9%
15/305
|
4.2%
13/308
|
|
General disorders
Asthenia
|
2.3%
7/305
|
2.6%
8/308
|
|
General disorders
Chest pain
|
1.6%
5/305
|
2.9%
9/308
|
|
General disorders
Fatigue
|
10.5%
32/305
|
6.8%
21/308
|
|
General disorders
Non-cardiac chest pain
|
7.5%
23/305
|
6.8%
21/308
|
|
General disorders
Oedema peripheral
|
6.2%
19/305
|
5.8%
18/308
|
|
Infections and infestations
Bronchitis
|
3.3%
10/305
|
4.5%
14/308
|
|
Infections and infestations
Influenza
|
5.2%
16/305
|
3.2%
10/308
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
23/305
|
4.2%
13/308
|
|
Infections and infestations
Sinusitis
|
2.0%
6/305
|
3.2%
10/308
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
7/305
|
2.6%
8/308
|
|
Infections and infestations
Urinary tract infection
|
2.6%
8/305
|
3.2%
10/308
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
7/305
|
1.9%
6/308
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
16/305
|
2.9%
9/308
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
21/305
|
4.2%
13/308
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.98%
3/305
|
2.9%
9/308
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.6%
8/305
|
4.5%
14/308
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
10/305
|
2.3%
7/308
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.6%
14/305
|
4.9%
15/308
|
|
Nervous system disorders
Dizziness
|
11.5%
35/305
|
9.1%
28/308
|
|
Nervous system disorders
Headache
|
5.9%
18/305
|
7.1%
22/308
|
|
Nervous system disorders
Hypoaesthesia
|
3.0%
9/305
|
2.3%
7/308
|
|
Nervous system disorders
Syncope
|
3.0%
9/305
|
1.3%
4/308
|
|
Psychiatric disorders
Anxiety
|
0.98%
3/305
|
2.9%
9/308
|
|
Psychiatric disorders
Depression
|
2.0%
6/305
|
3.9%
12/308
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.98%
3/305
|
2.9%
9/308
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.6%
14/305
|
3.9%
12/308
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.9%
12/305
|
5.5%
17/308
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.0%
9/305
|
0.32%
1/308
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.3%
7/305
|
1.3%
4/308
|
|
Vascular disorders
Hypertension
|
5.2%
16/305
|
7.1%
22/308
|
|
Vascular disorders
Hypotension
|
6.9%
21/305
|
3.9%
12/308
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER