Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension
Summary
Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in combination with amlodipine in patients with essential hypertension.
Timeline
- Start
- 2008-09
- Primary completion
- 2009-05
- Completion
- 2009-05
Outcome
Met primary endpoint
registry analysis (superiority or other test); Aliskiren 150 mg vs Aliskiren/Amlodipine 150/5 mg; p <0.001; Least Square Mean Difference -6.00 (95% CI -7.77 to -4.22); ANCOVA NCT00739973 ↗
registry analysis (superiority or other test); Amlodipine 5 mg vs Aliskiren/Amlodipine 150/5 mg; p = 0.001; Least Square Mean Difference -2.98 (95% CI -4.77 to -1.19); ANCOVA NCT00739973 ↗
registry analysis (superiority or other test); Placebo vs Aliskiren/Amlodipine 150/5 mg; p <0.001; Least Square Mean Difference -8.63 (95% CI -10.39 to -6.87); ANCOVA NCT00739973 ↗
registry analysis (superiority or other test); Aliskiren 150 mg vs Aliskiren/Amlodipine 150/10 mg; p <0.001; Least Square Mean Difference -8.17 (95% CI -9.94 to -6.40); ANCOVA NCT00739973 ↗
registry analysis (superiority or other test); Amlodipine 10 mg vs Aliskiren/Amlodipine 150/10 mg; p = 0.011; Least Sqaure Mean Difference -2.33 (95% CI -4.14 to -0.53); ANCOVA NCT00739973 ↗
registry analysis (superiority or other test); Placebo vs Aliskiren/Amlodipine 150/10 mg; p <0.001; Least Square Mean Difference -10.81 (95% CI -12.57 to -9.05); ANCOVA NCT00739973 ↗
registry analysis (superiority or other test); Aliskiren 300 mg vs Aliskiren/Amlodipine 300/5 mg; p <0.001; Least Square Mean Difference -4.79 (95% CI -6.56 to -3.03); ANCOVA NCT00739973 ↗
registry analysis (superiority or other test); Amlodipine 5 mg vs Aliskiren/Amlodipine 300/5 mg; p <0.001; Least Square Mean Difference -3.98 (95% CI -5.78 to -2.18); ANCOVA NCT00739973 ↗
registry analysis (superiority or other test); Placebo vs Aliskiren/Amlodipine 300/5 mg; p <0.001; Least Square Mean Difference -9.64 (95% CI -11.41 to -7.87); ANCOVA NCT00739973 ↗
registry analysis (superiority or other test); Aliskiren 300 mg vs Aliskiren/Amlodipine 300/10 mg Tablet; p <0.001; Least Square Mean Difference -6.26 (95% CI -8.00 to -4.51); ANCOVA NCT00739973 ↗
registry analysis (superiority or other test); Amlodipine 10 mg vs Aliskiren/Amlodipine 300/10 mg Tablet; p = 0.004; Least Square Mean Difference -2.63 (95% CI -4.42 to -0.83); ANCOVA NCT00739973 ↗
registry analysis (superiority or other test); Placebo vs Aliskiren/Amlodipine 300/10 mg Tablet; p <0.001; Least Square Mean Difference -11.10 (95% CI -12.85 to -9.35); ANCOVA NCT00739973 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aliskiren | Small molecule | 150 mg | Oral |
| Subject | Aliskiren | Small molecule | 300 mg | Oral |
| Subject | Amlodipine | Other / unclassified | 5 mg | Oral |
| Subject | Amlodipine | Other / unclassified | 10 mg | Oral |