Hypertension
Conditions
Keywords
Aliskiren, Amlodipine, Non-responder to Amlodipine
Brief summary
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.
Interventions
DRUGAmlodipine 10 mg
Amlodipine 10 mg
DRUGAliskiren 150
Aliskiren/Amlodipine 150/10 mg
DRUGAmlodipine 300
Aliskiren/Amlodipine 300/10 mg
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 95 mmHg and \< 110 mmHg at Visits 1 and 2 * Patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 90 mmHg and \< 110 mmHg at Visit 2 * All patients must have a msDBP ≥ 90 mmHg and \< 110 mmHg at Visit 5 (randomization)
Exclusion criteria
* Severe hypertension * Pregnant or nursing (lactating) women * Pre-menopausal women not taking accepted form of birth control * Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1 * History of cardiovascular conditions * Uncontrolled Type 1 or Type 2 diabetes mellitus * Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study | Baseline and Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study | Baseline and Week 8 |
| Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group | 8 weeks |
| Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS) | 12 weeks |
Countries
Argentina, Germany, Norway, Poland, Slovakia, Sweden, Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aliskiren/Amlodipine 300/10 mg Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning | 279 |
| Aliskiren/Amlodipine 150/10 mg Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning | 285 |
| Amlodipine 10 mg Oral capsules of amlodipine 10 mg taken once daily with water in the morning | 283 |
| Total | 847 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Abnormal Laboratory Value(s) | 1 | 0 | 0 |
| Overall Study | Abnormal Test Procedure Result(s) | 0 | 0 | 2 |
| Overall Study | Administrative Problems | 1 | 2 | 0 |
| Overall Study | Adverse Event | 9 | 10 | 14 |
| Overall Study | Lost to Follow-up | 0 | 2 | 1 |
| Overall Study | Not treated | 0 | 2 | 2 |
| Overall Study | Patient No Longer Requires Study Drug | 0 | 1 | 0 |
| Overall Study | Patient withdrew request | 3 | 1 | 6 |
| Overall Study | Protocol Violation | 3 | 0 | 2 |
| Overall Study | Unsatisfactory therapeutic response | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Aliskiren/Amlodipine 300/10 mg | Aliskiren/Amlodipine 150/10 mg | Amlodipine 10 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 10.19 | 54.4 years STANDARD_DEVIATION 10.7 | 54.3 years STANDARD_DEVIATION 10.92 | 54.6 years STANDARD_DEVIATION 10.6 |
| Sex: Female, Male Female | 116 Participants | 113 Participants | 99 Participants | 328 Participants |
| Sex: Female, Male Male | 163 Participants | 172 Participants | 184 Participants | 519 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 31 / 279 | 35 / 283 | 40 / 281 |
| serious Total, serious adverse events | 4 / 279 | 1 / 283 | 0 / 281 |
Outcome results
Primary
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
Time frame: Baseline and Week 8
Population: full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren/Amlodipine 300/10 mg | Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study | -10.99 mm Hg | Standard Error 0.462 |
| Aliskiren/Amlodipine 150/10 mg | Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study | -8.95 mm Hg | Standard Error 0.46 |
| Amlodipine 10 mg | Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study | -7.23 mm Hg | Standard Error 0.459 |
Secondary
Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS)
Time frame: 12 weeks
Secondary
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study
Time frame: Baseline and Week 8
Population: full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren/Amlodipine 300/10 mg | Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study | -14.42 mm Hg | Standard Error 0.684 |
| Aliskiren/Amlodipine 150/10 mg | Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study | -11.01 mm Hg | Standard Error 0.681 |
| Amlodipine 10 mg | Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study | -8.20 mm Hg | Standard Error 0.68 |
Secondary
Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group
Time frame: 8 weeks
Population: Analysis: Intention to Treat (ITT) Imputation Technique: Last Observation Carried Forward (LOCF)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aliskiren/Amlodipine 300/10 mg | Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group | 87 Participants |
| Aliskiren/Amlodipine 150/10 mg | Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group | 99 Participants |
| Amlodipine 10 mg | Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group | 92 Participants |