Phase 3
N=2,694
Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00739973 ↗Enrolled (actual)
2,694
Serious AEs
0.5%
Results posted
May 2011
Primary outcome: Primary: Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) — -7.99; -13.98 mm Hg — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Aliskiren 150 mg tablet (Drug); Aliskiren 300 mg tablet (Drug); Amlodipine 5 mg capsule (Drug); Amlodipine 10 mg capsule (Drug); Aliskiren/amlodipine 150/5 mg tablet (Drug); Aliskiren/amlodipine 150/10 mg tablet (Drug); Aliskiren/amlodipine 300/5 mg tablet (Drug); Aliskiren/amlodipine 300/10 mg tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) |
-7.99; -13.98 | <0.001 sig |
| PRIMARY Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) |
-11.0; -13.98 | 0.001 sig |
| PRIMARY Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) |
-5.35; -13.98 | <0.001 sig |
| PRIMARY Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) |
-7.99; -16.16 | <0.001 sig |
| PRIMARY Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) |
-13.82; -16.16 | 0.011 sig |
| PRIMARY Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) |
-5.35; -16.16 | <0.001 sig |
| PRIMARY Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) |
-10.19; -14.99 | <0.001 sig |
| PRIMARY Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) |
-11.0; -14.99 | <0.001 sig |
| PRIMARY Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) |
-5.35; -14.99 | <0.001 sig |
| PRIMARY Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) |
-10.19; -16.45 | <0.001 sig |
| PRIMARY Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) |
-13.82; -16.45 | 0.004 sig |
| PRIMARY Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) |
-5.35; -16.45 | <0.001 sig |
| SECONDARY Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) |
-10.67; -20.64 | <0.001 sig |
| SECONDARY Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) |
-15.82; -20.64 | 0.001 sig |
| SECONDARY Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) |
-6.79; -20.64 | <0.001 sig |
| SECONDARY Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP) |
-10.67; -23.87 | <0.001 sig |
| SECONDARY Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) |
-21.04; -23.87 | 0.056 |
| SECONDARY Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) |
-6.79; -23.87 | <0.001 sig |
| SECONDARY Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) |
-15.37; -21.82 | <0.001 sig |
| SECONDARY Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) |
-15.82; -21.82 | <0.001 sig |
| SECONDARY Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) |
-6.79; -21.82 | <0.001 sig |
| SECONDARY Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) |
-15.37; -23.19 | <0.001 sig |
| SECONDARY Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) |
-21.04; -23.19 | 0.143 |
| SECONDARY Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) |
-6.79; -23.19 | <0.001 sig |
| SECONDARY Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study |
19.2; 26.9; 36.3; 35.9; 50.3; 49.2 | — |
| SECONDARY Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response |
34.3; 50.3; 54.2; 62.0; 74.3; 73.2 | — |
| SECONDARY Percentage of Patients Achieving a Successful Systolic Blood Pressure Response |
32.3; 41.5; 53.2; 54.9; 72.1; 67.6 | — |
Summary
Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in combination with amlodipine in patients with essential hypertension.
Eligibility Criteria
Inclusion Criteria
- msDBP ≥ 90 mmHg and < 110 mmHg at the visit prior to Visit 3 (Visit 2 or optional Visit 201)
- msDBP ≥ 95 mmHg and < 110 mmHg at Visit 3 (Day 1 / randomization).
- All patients must have an absolute difference of ≤ 10 mmHg in their msDBP during the last 2 visits of the single-blind run-in period (Visit 2 and 3 or Visits 201 and 3).
Exclusion Criteria
- Severe hypertension
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
- Previous or current diagnosis of heart failure (NYHA Class II-IV).
- Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1.
- Uncontrolled Type 1 or Type 2 diabetes mellitus
- Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
- History of malignancy within 5 years
- History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention
Data sourced from ClinicalTrials.gov (NCT00739973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.