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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1080 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Analysis of Factors Influencing the Efficacy of Levamlodipine Benzoate and Its Population Pharmacodynamic Modeling

NCT05958524

Hypertensive Patients Monotherapy

UNKNOWN

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

NCT00289406

Hypertension

COMPLETED PHASE3

A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient

NCT00415623

Hypertension

COMPLETED PHASE3

A Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan/Levamlodipine (SYH9056) Tablets In Hypertensive Patients

NCT06771245

Mild-to-moderate Essential Hypertension

NOT_YET_RECRUITING PHASE3

To Assess Allisartan Isoproxil/Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine or Allisartan Isoproxil

NCT06465264

Essential Hypertension

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Essential Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Levamlodipine besylate (2.5mg)

Group Type EXPERIMENTAL

Levamlodipine besylate

Intervention Type DRUG

Once daily, 7AM - 10AM

Levamlodipine besylate (5mg)

Group Type EXPERIMENTAL

Levamlodipine besylate

Intervention Type DRUG

Once daily, 7AM - 10AM

Amlodipine maleate (5mg)

Group Type ACTIVE_COMPARATOR

Amlodipine maleate

Intervention Type DRUG

Once daily, 7AM - 10AM

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levamlodipine besylate

Once daily, 7AM - 10AM

Intervention Type DRUG

Amlodipine maleate

Once daily, 7AM - 10AM

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No