Efficacy and Safety Study of S-Amlodipine Gentisate Compared to Amlodipine Besylate to Treat Mild-to-Moderate Hypertension

An 8 Weeks, Multi-Center, Randomized, Double Blinded, Comparative Phase 3 Clinical Trial to Assess the Efficacy and Safety of S-Amlodipine Gentisate Compared to Amlodipine Besylate in Patients With Mild-to-Moderate Hypertension

The goal of this study is to compare the antihypertensive effect and tolerability of S-amlodipine gentisate with those of amlodipine besylate in patients with mild to moderate hypertension.

Inclusion Criteria:

• patients are required to have a mean cuff sitting diastolic blood pressure of ≥90 and ≤109 mmHg after successful completion of the 2-week placebo run-in period

Exclusion Criteria:

• any serious disorder that could limit the ability of the patient to participate in the study
• significant cardiovascular disease (angina, myocardial infarction, cerebrovascular disease, or significant arrhythmia in the preceding 6 months)
• uncontrolled diabetes mellitus (serum glucose level ≥140 mg/dl)
• insulin dependent diabetes mellitus (type I)
• secondary hypertension