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

May 30, 2011 updated by: Jiangsu Simcere Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1080

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levamlodipine besylate (2.5mg)
Drug: Levamlodipine besylate
Once daily, 7AM - 10AM
Experimental: Levamlodipine besylate (5mg)
Drug: Levamlodipine besylate
Once daily, 7AM - 10AM
Active Comparator: Amlodipine maleate (5mg)
Drug: Amlodipine maleate
Once daily, 7AM - 10AM

What is the study measuring?

Primary Outcome Measures

Outcome 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)
Time Frame: Week 8
Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse effects
Time Frame: 8 weeks
8 weeks
Change from baseline in systolic blood pressure (SBP)
Time Frame: Week 8
Week 8
Change from baseline in diastolic blood pressure (DBP)
Time Frame: Week 8
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Dayi Hu, MD, Peking University People's Hospital
  • Principal Investigator: Jinming Yu, Ph.D., School of Public Health，Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

May 25, 2010

First Submitted That Met QC Criteria

May 25, 2010

First Posted (Estimate)

May 27, 2010

Study Record Updates

Last Update Posted (Estimate)

June 1, 2011

Last Update Submitted That Met QC Criteria

May 30, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIM-77

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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