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

Phase 4

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Levamlodipine besylate; Drug: Amlodipine maleate

• Registration Number: NCT01131546
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-27
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-30
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1080

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levamlodipine besylate (5mg)	Levamlodipine besylate	-
Levamlodipine besylate (2.5mg)	Levamlodipine besylate	-
Amlodipine maleate (5mg)	Amlodipine maleate	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients who reach overall blood pressure control (defined as BP <140/90 mmHg for non-diabetic patients and < 130/80 mmHg for diabetic patients)	Week 8

Secondary Outcome Measures

Name	Time	Method
Change from baseline in systolic blood pressure (SBP)	Week 8
Change from baseline in diastolic blood pressure (DBP)	Week 8
Incidence of adverse effects	8 weeks

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China