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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01122251

Enrollment

441

Registered

2010-05-13

Start date

2009-12-31

Completion date

2010-07-31

Last updated

2011-02-18

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

Conditions

Essential Hypertension

Keywords

hypertension, lercanidipine, valsartan

Brief 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.

Interventions

DRUGLercanidipine + Valsartan

L10/V80, L20/V80, L10/V160, L20/V160

DRUGLercanidipine or Valsartan

L10, L20, V80, V160

DRUGPlacebo

Placebo of Lercanidipine and Valsartan

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients aged between 20 and 75 * Essential hypertension at screening (-3 week) Randomization Criteria: * Essential hypertension at baseline (90mmHg≤sitDBP≤109mmHg, except sitSBP≥180)

Exclusion criteria

* Mean sitDBP≥110mmHg or sitSBP≥180 * Secondary hypertension or suspected secondary hypertension * Uncontrolled diabetes * Severe heart disease or severe cerebrovascular disease * clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST) * History of malignant disease * Autoimmune disease * Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial

Design outcomes

Primary

Measure	Time frame	Description
sitDBP	Baseline, Week 8	Average changes from baseline in sitDBP

Secondary

Measure	Time frame	Description
sitDBP	Week 4, 8	Response rates (proportion of patients sitDBP\<90mmHg or ≥10-mmHg reduction from baseline)
sitSBP	Week 4, 8	Average changes from baselini in sitSBP

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026