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

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.

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