NCT00931710

Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension

A 12-week Multicenter, Randomized, Double-blind, Parallel-group, Active-control Study to Evaluate the Antihypertensive Efficacy and Safety of Valsartan/Amlodipine-based Regimen Versus a Losartan-based Regimen in Patients With Stage 2 Systolic Hypertension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 488 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).

Conditions

• Stage 2 Systolic Hypertension

Interventions

Type	Name	Description
DRUG	valsartan, amlodipine, HCTZ	combination Valsartan/amlodipine160/5 mg tablet for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (6 weeks) of the study
DRUG	Losartan, HCTZ followed by valsartan, amlodipine, HCTZ	losartan 100mg capsule for 3 weeks; losartan 100mg capsule +HCTZ 25 mg capsule for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (3 weeks) of the study

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-07-02
• Last updated: 2011-03-07
• Results posted: 2011-02-04

Locations

1 site across 1 country: United States