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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: Lercanidipine + Valsartan
* Drug: Lercanidipine or Valsartan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lercanidpine + Valsartan<br>L10/V80, L20/V80, L10/V160, L20/V160 | Drug: Lercanidipine + Valsartan<br>* L10/V80, L20/V80, L10/V160, L20/V160<br>|
| Active Comparator: Lercanidipine or Valsartan<br>L10, L20, V80, V160 | Drug: Lercanidipine or Valsartan<br>* L10, L20, V80, V160<br>|
| Placebo Comparator: Placebo<br>Placebo comparators of Lercanidipine and Valsartan | Drug: Placebo<br>* Placebo of Lercanidipine and Valsartan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sitDBP | Average changes from baseline in sitDBP | Baseline, Week 8 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, lercanidipine, valsartan