drugset / Trial / NCT00809926

8 Weeks Study to Evaluate the Efficacy and Safety of Valsartan in Combination With Aliskiren Compared to Valsartan Alone in Patients With Stage 2 Hypertension

NCT00809926 ↗

Phase 4 Completed 451 enrolled Novartis
RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the efficacy and safety of the valsartan/aliskiren combination compared to valsartan alone in patients with Stage 2 hypertension.

Timeline

Start
2009-01
Primary completion
2009-07
Completion
2009-07

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Valsartan/Aliskiren vs Valsartan; p = 0.295; Least Square Mean Difference -1.6 (95% CI -4.61 to 1.40); ANCOVA NCT00809926 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Aliskiren Small molecule 300 mg —
Subject Valsartan Unknown 320 mg —

Indications