Efficacy and Safety of Levamlodipine Besylate Compared to Amlodipine Maleate in Patients With Essential Hypertension

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to compare the safety and efficacy of levamlodipine besylate (2.5mg or 5mg) versus amlodipine maleate (5mg) in patients with mild to moderate essential hypertension.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Amlodipine; Maleic acid; Niacin

Criteria

Inclusion Criteria:

• Male or female outpatients, 18-75 Years

• Patients with mild to moderate essential hypertension (defined as mean BP of 2 visits ≥140mm/90mmHg, and < 180mm/110mmHg)

• Written informed consent

Exclusion Criteria:

• Patients with secondary hypertension

• Patients with severe hypertension

• Have to take other drugs that can influence blood pressure during the study

• Allergic to DHP calcium antagonists

• Evidence of congestive heart failure, unstable angina or severe arrhythmia

• Renal or hepatic dysfunction

• Women who are taking contraceptive pills or are likely to be pregnant

• Participate in other clinical trials within 3 months prior to this study