NCT00797316

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

An 8-week Randomized, Double-blind, Parallel-group, Multi-center, Forced-titration Study to Evaluate the Efficacy and Safety of Aliskiren Plus HCTZ Compared to Aliskiren Monotherapy in Metabolic Syndrome Patients With Stage 2 Hypertension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 532 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Aliskiren	Aliskiren 150 mg or 300 mg taken once daily in oral form
DRUG	Hydrochlorothiazide	Hydrochlorothiazide 12.5 mg or 25 mg taken once daily in oral form.

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-11-25
• Last updated: 2011-03-11
• Results posted: 2011-01-12

Locations

1 site across 1 country: United States