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

A Randomized, Multicenter, Parallel Design Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients Who Are Not Adequately Controlled on Lercanidipine 10mg Monotherapy.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01928628

Enrollment

449

Registered

2013-08-27

Start date

2012-05-31

Completion date

Unknown

Last updated

2013-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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

Interventions

DRUGLercanidipine 10mg

DRUGLercanidipine10mg /Valsartan 80mg

DRUGLercanidipine 10mg /Valsartan 160mg

DRUGLercanidipin 10mg Placebo

DRUGLercanidipine10mg /Valsartan 80mg Placebo

DRUGLercanidipine 10mg /Valsartan 160mg Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in mean sitDBP from week 0 to week 40	40 weeks

Secondary

Measure	Time frame	Description
Response rate at week 4 and 8	4 weeks and 8 weeks	Proportion (%) of patients with mean sitDBP\<90mmHg or proportion (%) of patients with mean reduction of sitDBP ≥10mmHg from week 0

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026