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

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ClinicalTrials.gov Identifier: NCT01131546
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : June 1, 2011
Sponsor:
Information provided by:
Jiangsu Simcere Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Levamlodipine besylate Drug: Amlodipine maleate Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Multicenter Trial of Levamlodipine Besylate Versus Amlodipine Maleate in Patients With Essential Hypertension
Study Start Date : December 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  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) [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Change from baseline in systolic blood pressure (SBP) [ Time Frame: Week 8 ]
  2. Change from baseline in diastolic blood pressure (DBP) [ Time Frame: Week 8 ]
  3. Incidence of adverse effects [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131546


Locations
China
Peking University People's Hospital
Beijing, China
Sponsors and Collaborators
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

Responsible Party: Jinsheng Ren, Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
ClinicalTrials.gov Identifier: NCT01131546     History of Changes
Other Study ID Numbers: SIM-77
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 2011

Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:
Essential Hypertension
Levamlodipine Besylate
Amlodipine Maleate

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Niacin
Maleic acid
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Enzyme Inhibitors
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs