NCT00787605

Aliskiren HCTZ Compared to Amlodipine in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus

An 8-week Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ (300/25 mg) Compared to Amlodipine (10 mg) in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 860 (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) given to diabetic patients with stage 2 systolic hypertension (mean sitting systolic blood pressure (msSBP) ≥ 160 mm Hg and \< 200 mm Hg).

Conditions

• Hypertension
• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Amlodipine	Amlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks
DRUG	Hydrochlorothiazide (HCTZ)	Hydrochlorothiazide 12.5 mg for 1 week followed by Hydrochlorothiazide 25 mg for 7 weeks
DRUG	Aliskiren	Aliskiren 150 mg for 1 week followed by Aliskiren 300 mg for 7 weeks

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-11-07
• Last updated: 2016-10-27
• Results posted: 2011-05-23

Locations

1 site across 1 country: United States