Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients

Phase 3CompletedNCT01928628

LG Life Sciences449 enrolled

Overview

This study aims to compare and assess the efficacy and the safety of the combination agent of Lercanidipine and Valsartan and monotherapy of Lercanidipine alone in patients with essential hypertension

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

449

Conditions

Hypertension

Interventions

Lercanidipine 10mgDRUG

Lercanidipine10mg /Valsartan 80mgDRUG

Lercanidipine 10mg /Valsartan 160mgDRUG

Lercanidipin 10mg PlaceboDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged ≥ 20 to ≤75 years old * Patient with essential hypertension Exclusion Criteria: * When the BP level measured at screening was sitDBP\>120 mmHg or sitSBP \>180 mmHg * Patient with difference in repeatedly measured blood pressures from the selected arm at screening was sitSBP≥ 20mmHg or sitDBP ≥ 10mmHg

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Change in mean sitDBP from week 0 to week 40

Time frame: 40 weeks

Secondary Outcomes

Response rate at week 4 and 8

Proportion (%) of patients with mean sitDBP\<90mmHg or proportion (%) of patients with mean reduction of sitDBP ≥10mmHg from week 0

Time frame: 4 weeks and 8 weeks

Data from ClinicalTrials.gov

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