Trial Outcomes & Findings for An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure (NCT NCT00402103)
NCT ID: NCT00402103
Last Updated: 2011-03-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
556 participants
Primary outcome timeframe
52 weeks
Results posted on
2011-03-10
Participant Flow
Participant milestones
| Measure |
Aliskiren/Amlodipine
Aliskiren and Amlodipine tablets once a day in the morning
|
Aliskiren/Amlodipine/HCTZ
Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
|
|---|---|---|
|
Overall Study
STARTED
|
470
|
86
|
|
Overall Study
COMPLETED
|
379
|
73
|
|
Overall Study
NOT COMPLETED
|
91
|
13
|
Reasons for withdrawal
| Measure |
Aliskiren/Amlodipine
Aliskiren and Amlodipine tablets once a day in the morning
|
Aliskiren/Amlodipine/HCTZ
Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
|
|---|---|---|
|
Overall Study
Adverse Event
|
60
|
7
|
|
Overall Study
Unsatisfactory therapeutic effect
|
1
|
2
|
|
Overall Study
Condition no longer requires study drug
|
2
|
0
|
|
Overall Study
Protocol Deviation
|
8
|
0
|
|
Overall Study
Patient withdrew consent
|
12
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
3
|
|
Overall Study
Administrative problems
|
2
|
0
|
Baseline Characteristics
An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure
Baseline characteristics by cohort
| Measure |
Aliskiren/Amlodipine
n=470 Participants
Aliskiren and Amlodipine tablets once a day in the morning
|
Aliskiren/Amlodipine/HCTZ
n=86 Participants
Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
|
Total
n=556 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
54.2 years
STANDARD_DEVIATION 11.66 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 11.33 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 11.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
274 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Treated Population
Outcome measures
| Measure |
Aliskiren 150mg/ Amlodipine 5mg Alone
n=556 Participants
Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning
|
Aliskiren 300mg/ Amlodipine 10mg Alone
n=546 Participants
Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning
|
Aliskiren 300mg/ Amlodipine 10mg/ HCTZ
n=86 Participants
Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning
|
|---|---|---|---|
|
Overall Percentage of Patients With Adverse Events
|
23.6 Percentage of Participants
|
71.2 Percentage of Participants
|
57.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54Population: Treated population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.
Outcome measures
| Measure |
Aliskiren 150mg/ Amlodipine 5mg Alone
n=470 Participants
Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning
|
Aliskiren 300mg/ Amlodipine 10mg Alone
n=86 Participants
Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning
|
Aliskiren 300mg/ Amlodipine 10mg/ HCTZ
Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning
|
|---|---|---|---|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points
Week 2 (Visit 5)
|
-8.7 mm Hg
Standard Deviation 6.94
|
-5.9 mm Hg
Standard Deviation 6.05
|
—
|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points
Week 4 (Visit 6)
|
-14.0 mm Hg
Standard Deviation 6.88
|
-11.9 mm Hg
Standard Deviation 5.58
|
—
|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points
Week 6 (Visit 7)
|
-15.7 mm Hg
Standard Deviation 6.96
|
-11.5 mm Hg
Standard Deviation 7.36
|
—
|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points
Week 10 (Visit 8)
|
-16.3 mm Hg
Standard Deviation 6.69
|
-9.3 mm Hg
Standard Deviation 7.22
|
—
|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points
Week 14 (Visit 9)
|
-17.1 mm Hg
Standard Deviation 6.84
|
-13.1 mm Hg
Standard Deviation 7.64
|
—
|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points
Week 28 (Visit 10)
|
-16.7 mm Hg
Standard Deviation 7.15
|
-14.7 mm Hg
Standard Deviation 8.22
|
—
|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points
Week 41 (Visit 11)
|
-17.0 mm Hg
Standard Deviation 7.26
|
-15.4 mm Hg
Standard Deviation 6.86
|
—
|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points
Week 54 (Visit 12)
|
-16.3 mm Hg
Standard Deviation 7.13
|
-15.3 mm Hg
Standard Deviation 6.55
|
—
|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points
Week 54 (Visit 12) (LOCF)
|
-15.7 mm Hg
Standard Deviation 7.61
|
-14.2 mm Hg
Standard Deviation 7.90
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 10, Week 28 and Week 54Population: Treated Population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.
Outcome measures
| Measure |
Aliskiren 150mg/ Amlodipine 5mg Alone
n=470 Participants
Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning
|
Aliskiren 300mg/ Amlodipine 10mg Alone
n=86 Participants
Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning
|
Aliskiren 300mg/ Amlodipine 10mg/ HCTZ
Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning
|
|---|---|---|---|
|
Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg
Week 2 (Visit 5)
|
35.3 Percentage of patients
88.0
|
8.1 Percentage of patients
|
—
|
|
Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg
Week 10 (Visit 8)
|
88.0 Percentage of patients
|
16.3 Percentage of patients
|
—
|
|
Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg
Week 28 (Visit 10)
|
88.2 Percentage of patients
|
56.8 Percentage of patients
|
—
|
|
Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg
Week 54 (Visit 12)
|
82.0 Percentage of patients
|
62.2 Percentage of patients
|
—
|
|
Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg
Week 54 (Visit 12) (LOCF)
|
77.3 Percentage of patients
|
58.1 Percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 10, Week 28 and Week 54Population: Treated Population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.
Outcome measures
| Measure |
Aliskiren 150mg/ Amlodipine 5mg Alone
n=470 Participants
Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning
|
Aliskiren 300mg/ Amlodipine 10mg Alone
n=86 Participants
Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning
|
Aliskiren 300mg/ Amlodipine 10mg/ HCTZ
Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning
|
|---|---|---|---|
|
Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)
Week 2 (Visit 5)
|
61.2 Percentage of patients
|
38.4 Percentage of patients
|
—
|
|
Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)
Week 10 (Visit 8)
|
96.8 Percentage of patients
|
61.6 Percentage of patients
|
—
|
|
Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)
Week 28 (Visit 10)
|
95.9 Percentage of patients
|
85.2 Percentage of patients
|
—
|
|
Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)
Week 54 (Visit 12)
|
93.2 Percentage of patients
|
89.2 Percentage of patients
|
—
|
|
Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)
Week 54 (Visit 12) (LOCF)
|
90.6 Percentage of patients
|
84.9 Percentage of patients
|
—
|
Adverse Events
Aliskiren 150mg/ Amlodipine 5mg Alone
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Aliskiren 300mg/ Amlodipine 10mg Alone
Serious events: 13 serious events
Other events: 138 other events
Deaths: 0 deaths
Aliskiren 300mg/ Amlodipine 10mg/ HCTZ
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aliskiren 150mg/ Amlodipine 5mg Alone
n=556 participants at risk
Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning
|
Aliskiren 300mg/ Amlodipine 10mg Alone
n=546 participants at risk
Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning
|
Aliskiren 300mg/ Amlodipine 10mg/ HCTZ
n=86 participants at risk
Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Infections and infestations
Amoebiasis
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Infections and infestations
Gangrene
|
0.00%
0/556
|
0.00%
0/546
|
1.2%
1/86
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Psychiatric disorders
Depression
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/556
|
0.18%
1/546
|
0.00%
0/86
|
|
Vascular disorders
Hypotension
|
0.00%
0/556
|
0.00%
0/546
|
1.2%
1/86
|
Other adverse events
| Measure |
Aliskiren 150mg/ Amlodipine 5mg Alone
n=556 participants at risk
Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning
|
Aliskiren 300mg/ Amlodipine 10mg Alone
n=546 participants at risk
Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning
|
Aliskiren 300mg/ Amlodipine 10mg/ HCTZ
n=86 participants at risk
Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning
|
|---|---|---|---|
|
General disorders
Oedema peripheral
|
1.4%
8/556
|
19.8%
108/546
|
14.0%
12/86
|
|
Infections and infestations
Upper respiratory tract infection
|
0.90%
5/556
|
5.9%
32/546
|
5.8%
5/86
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.18%
1/556
|
0.92%
5/546
|
5.8%
5/86
|
Additional Information
Study Director
Novartis Pharmaceuticals
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