NCT01122251

Efficacy and Safety of Lercanidipine and Valsartan in Patients With Essential Hypertension

A Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy Phase II Trial to Evaluate the Efficacy and Safety of the Combinations of Lercanidipine and Valsartan in Comparison to Each Component Administered Alone and to Determine the Optimal Dose Combinations in Patients With Essential Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 441 (estimated)
• Sponsor: LG Life Sciences · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of fixed combination of lercanidipine (10 mg or 20 mg) and valsartan (80 mg or 160 mg), lercanidipine and valsartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Lercanidipine + Valsartan	L10/V80, L20/V80, L10/V160, L20/V160
DRUG	Lercanidipine or Valsartan	L10, L20, V80, V160
DRUG	Placebo	Placebo of Lercanidipine and Valsartan

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-05-01
• Completion: 2010-07-01
• First posted: 2010-05-13
• Last updated: 2011-02-18

Locations

2 sites across 1 country: South Korea