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
1 other identifier
interventional
1,080
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 25, 2010
CompletedFirst Posted
Study publicly available on registry
May 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJune 1, 2011
May 1, 2011
1.2 years
May 25, 2010
May 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (3)
Levamlodipine besylate (2.5mg)
EXPERIMENTALLevamlodipine besylate (5mg)
EXPERIMENTALAmlodipine maleate (5mg)
ACTIVE COMPARATORInterventions
Once daily, 7AM - 10AM
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dayi Hu, MD
Peking University People's Hospital
- PRINCIPAL INVESTIGATOR
Jinming Yu, Ph.D.
School of Public Health，Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 25, 2010
First Posted
May 27, 2010
Study Start
December 1, 2009
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
June 1, 2011
Record last verified: 2011-05