Trial Outcomes & Findings for A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly (NCT NCT00368277)
NCT ID: NCT00368277
Last Updated: 2011-03-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
901 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2011-03-25
Participant Flow
Participant milestones
| Measure |
Aliskiren Based Treatment Regimen
Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
|
Ramipril Based Treatment Regimen
Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
|
|---|---|---|
|
Overall Study
STARTED
|
457
|
444
|
|
Overall Study
COMPLETED
|
344
|
336
|
|
Overall Study
NOT COMPLETED
|
113
|
108
|
Reasons for withdrawal
| Measure |
Aliskiren Based Treatment Regimen
Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
|
Ramipril Based Treatment Regimen
Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
|
|---|---|---|
|
Overall Study
Adverse Event
|
33
|
49
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
31
|
24
|
|
Overall Study
Protocol deviation
|
7
|
0
|
|
Overall Study
Patient withdrew consent
|
32
|
28
|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
Baseline Characteristics
A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly
Baseline characteristics by cohort
| Measure |
Aliskiren Based Treatment Regimen
n=457 Participants
Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
|
Ramipril Based Treatment Regimen
n=444 Participants
Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
|
Total
n=901 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
72.0 years
STANDARD_DEVIATION 5.56 • n=5 Participants
|
72.2 years
STANDARD_DEVIATION 5.62 • n=7 Participants
|
72.1 years
STANDARD_DEVIATION 5.58 • n=5 Participants
|
|
Age, Customized
65 - 74 years
|
312 participants
n=5 Participants
|
296 participants
n=7 Participants
|
608 participants
n=5 Participants
|
|
Age, Customized
75 years and older
|
145 participants
n=5 Participants
|
148 participants
n=7 Participants
|
293 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
235 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
472 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
222 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
429 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to treat (ITT), Last Observation Carried forward (LOCF)
Outcome measures
| Measure |
Aliskiren Based Treatment Regimen
n=451 Participants
Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
|
Ramipril Based Treatment Regimen
n=439 Participants
Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
|
|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12
|
-13.96 mm Hg
Standard Error 0.754 • Interval -15.15 to -12.13
|
-11.64 mm Hg
Standard Error 0.759 • Interval -12.76 to -9.9
|
SECONDARY outcome
Timeframe: Weeks 12 and 36Population: Safety population
Outcome measures
| Measure |
Aliskiren Based Treatment Regimen
n=452 Participants
Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
|
Ramipril Based Treatment Regimen
n=444 Participants
Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
|
|---|---|---|
|
Percentage of Patients With Cough
Week 12
|
3.1 Percentage of Participants
0.788
|
9.9 Percentage of Participants
0.794
|
|
Percentage of Patients With Cough
Week 36
|
4.4 Percentage of Participants
|
14.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Weeks 12 and 36Population: intent to treat (ITT), last observation carried forward (LOCF)
Blood pressure control is defined as a mean sitting blood pressure \< 140/90 mm Hg
Outcome measures
| Measure |
Aliskiren Based Treatment Regimen
n=451 Participants
Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
|
Ramipril Based Treatment Regimen
n=440 Participants
Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
|
|---|---|---|
|
Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints
week 12 endpoint
|
46.3 Percentage of participants
|
39.3 Percentage of participants
|
|
Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints
week 36 endpoint
|
65.6 Percentage of participants
|
57.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and week 36Population: Intent to treat (ITT), Last Observation Carried forward (LOCF)
Outcome measures
| Measure |
Aliskiren Based Treatment Regimen
n=451 Participants
Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
|
Ramipril Based Treatment Regimen
n=439 Participants
Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
|
|---|---|---|
|
Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36
|
-8.24 mm Hg
Standard Error 0.409
|
-7.02 mm Hg
Standard Error 0.411
|
Adverse Events
Aliskiren
Serious events: 35 serious events
Other events: 170 other events
Deaths: 0 deaths
Ramipril
Serious events: 27 serious events
Other events: 181 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aliskiren
n=452 participants at risk
Aliskiren based regimen
|
Ramipril
n=444 participants at risk
Ramipril based regimen
|
|---|---|---|
|
Gastrointestinal disorders
Aphagia
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Gastrointestinal disorders
Ascites
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.44%
2/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Eye disorders
Diplopia
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Eye disorders
Eye movement disorder
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Cardiac disorders
Trifascicular block
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Cardiac disorders
Ventricular tachycardia
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.44%
2/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.66%
3/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.22%
1/452 • 36 weeks
|
0.45%
2/444 • 36 weeks
|
|
Cardiac disorders
Sinus bradycardia
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.44%
2/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
General disorders
Malaise
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.66%
3/452 • 36 weeks
|
0.68%
3/444 • 36 weeks
|
|
General disorders
Oedema peripheral
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Infections and infestations
Catheter site infection
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Infections and infestations
Diverticulitis
|
0.22%
1/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Infections and infestations
Myringitis bullous
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Infections and infestations
Otitis externa
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Infections and infestations
Pneumonia
|
0.44%
2/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.22%
1/452 • 36 weeks
|
0.45%
2/444 • 36 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.44%
2/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.22%
1/452 • 36 weeks
|
0.68%
3/444 • 36 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/452 • 36 weeks
|
0.45%
2/444 • 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage 0
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.44%
2/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Nervous system disorders
Coma
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Nervous system disorders
Convulsion
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Nervous system disorders
Syncope
|
0.44%
2/452 • 36 weeks
|
0.90%
4/444 • 36 weeks
|
|
Nervous system disorders
VIth nerve paralysis
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Vascular disorders
Femoral arterial stenosis
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Vascular disorders
Haematoma
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Vascular disorders
Hypertension
|
0.22%
1/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
|
Vascular disorders
Hypotension
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Vascular disorders
Intermittent claudication
|
0.22%
1/452 • 36 weeks
|
0.00%
0/444 • 36 weeks
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/452 • 36 weeks
|
0.23%
1/444 • 36 weeks
|
Other adverse events
| Measure |
Aliskiren
n=452 participants at risk
Aliskiren based regimen
|
Ramipril
n=444 participants at risk
Ramipril based regimen
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
29/452 • 36 weeks
|
5.0%
22/444 • 36 weeks
|
|
General disorders
Fatigue
|
6.2%
28/452 • 36 weeks
|
4.5%
20/444 • 36 weeks
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
23/452 • 36 weeks
|
4.5%
20/444 • 36 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
35/452 • 36 weeks
|
6.3%
28/444 • 36 weeks
|
|
Infections and infestations
Urinary tract infection
|
3.8%
17/452 • 36 weeks
|
5.4%
24/444 • 36 weeks
|
|
Nervous system disorders
Dizziness
|
7.5%
34/452 • 36 weeks
|
8.3%
37/444 • 36 weeks
|
|
Nervous system disorders
Headache
|
9.3%
42/452 • 36 weeks
|
9.0%
40/444 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
19/452 • 36 weeks
|
13.3%
59/444 • 36 weeks
|
Additional Information
Study Director
Novaris Phamaceuticals
Phone: 862-778-8300
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.
- Publication restrictions are in place
Restriction type: OTHER