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

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SK Chemicals Co., Ltd.; SK Chemicals Co.,Ltd.
• Treatments: Amlodipine

Criteria

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