drugset / Trial / NCT00797316

Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic Hypertension

NCT00797316

Phase 4 Completed 532 enrolled Novartis
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) compared to aliskiren monotherapy when given to metabolic syndrome patients with stage 2 systolic hypertension (mean sitting systolic blood pressure \[msSBP\] ≥ 160 mm Hg and \< 200 mm Hg).

Timeline

Start
2008-11
Primary completion
2009-12
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Aliskiren Small molecule 300 mg Oral
Subject Hydrochlorothiazide Unknown 25 mg Oral

Indications