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

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Lercanidipine 10mg
* Drug: Lercanidipine10mg /Valsartan 80mg
* Drug: Lercanidipine 10mg /Valsartan 160mg
* Drug: Lercanidipin 10mg Placebo
* Drug: Lercanidipine10mg /Valsartan 80mg Placebo
* Drug: Lercanidipine 10mg /Valsartan 160mg Placebo


Participation Criteria
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Eligibility Criteria
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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

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lercanidipine 10mg<br>1 Tablet of Zanidip ® 10mg + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/V160 Placebo (8wks) | Drug: Lercanidipine 10mg<br> <br> Drug: Lercanidipine10mg /Valsartan 80mg Placebo<br> <br> Drug: Lercanidipine 10mg /Valsartan 160mg Placebo<br> <br> |
| Experimental: Lercanidipine10mg /Valsartan 80mg<br>1 Tablet of Zanidip ® 10mg Placebo +1 Tablet of L10/V80 + 1 Tablet of L10/V160 Placebo (8wks) | Drug: Lercanidipine10mg /Valsartan 80mg<br> <br> Drug: Lercanidipin 10mg Placebo<br> <br> Drug: Lercanidipine 10mg /Valsartan 160mg Placebo<br> <br> |
| Experimental: Lercanidipine 10mg /Valsartan 160mg<br>1 Tablet of Zanidip ® 10mg Placebo + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/ V160 (8wks) | Drug: Lercanidipine 10mg /Valsartan 160mg<br> <br> Drug: Lercanidipin 10mg Placebo<br> <br> Drug: Lercanidipine10mg /Valsartan 80mg Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean sitDBP from week 0 to week 40 |  | 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 weeks and 8 weeks |