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

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Levamlodipine besylate
Amlodipine maleate
Sponsored by
Jiangsu Simcere Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Essential Hypertension, Levamlodipine Besylate, Amlodipine Maleate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Peking University People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Levamlodipine besylate (2.5mg)

Levamlodipine besylate (5mg)

Amlodipine maleate (5mg)

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change from baseline in systolic blood pressure (SBP)
Change from baseline in diastolic blood pressure (DBP)
Incidence of adverse effects

Full Information

First Posted
May 25, 2010
Last Updated
May 30, 2011
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01131546
Brief Title
Efficacy and Safety of Levamlodipine Besylate Compared to Amlodipine Maleate in Patients With Essential Hypertension
Official Title
A Randomized, Controlled, Multicenter Trial of Levamlodipine Besylate Versus Amlodipine Maleate in Patients With Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Essential Hypertension, Levamlodipine Besylate, Amlodipine Maleate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1080 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Levamlodipine besylate (2.5mg)
Arm Type
Experimental
Arm Title
Levamlodipine besylate (5mg)
Arm Type
Experimental
Arm Title
Amlodipine maleate (5mg)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Levamlodipine besylate
Intervention Description
Once daily, 7AM - 10AM
Intervention Type
Drug
Intervention Name(s)
Amlodipine maleate
Intervention Description
Once daily, 7AM - 10AM
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change from baseline in systolic blood pressure (SBP)
Time Frame
Week 8
Title
Change from baseline in diastolic blood pressure (DBP)
Time Frame
Week 8
Title
Incidence of adverse effects
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dayi Hu, MD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jinming Yu, Ph.D.
Organizational Affiliation
School of Public Health,Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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