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

Simcere

Status and phase: Completed; Phase 4

Conditions: Essential Hypertension

Treatments: Drug: Levamlodipine besylate; Drug: Amlodipine maleate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01131546

SIM-77

Details and patient eligibility

About

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.

Enrollment: 1,080 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,080 participants in 3 patient groups

Levamlodipine besylate (2.5mg)

Experimental group

Treatment:

Drug: Levamlodipine besylate

Levamlodipine besylate (5mg)

Experimental group

Treatment:

Drug: Levamlodipine besylate

Amlodipine maleate (5mg)

Active Comparator group

Treatment:

Drug: Amlodipine maleate