NCT00942344

Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension

An 8-week, Multicenter, Randomized, Double-blind, Factorial Phase II Study to Evaluate Dose-response Relationship of Amlodipine and Losartan Combination in Patients With Essential Hypertension.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of fixed combination of amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Amlodipine plus Losartan	amlodipine/losartan 5/50mg, 5/100mg, 10/50mg, 10/100mg
DRUG	Amlodipine	amlodipine 5mg, 10mg
DRUG	Losartan	Losartan 50mg, 100mg

Timeline

• Start date: 2007-05-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2009-07-20
• Last updated: 2009-07-20

Locations

1 site across 1 country: South Korea