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

A Randomized, Controlled, Multicenter Trial of Levamlodipine Besylate Versus Amlodipine Maleate in Patients With Essential Hypertension

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01131546

Enrollment

1080

Registered

2010-05-27

Start date

2009-12-31

Completion date

2011-03-31

Last updated

2011-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Keywords

Essential Hypertension, Levamlodipine Besylate, Amlodipine Maleate

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.

Interventions

DRUGLevamlodipine besylate

Once daily, 7AM - 10AM

DRUGAmlodipine maleate

Once daily, 7AM - 10AM

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026