Efficacy and Safety of Levamlodipine Besylate Compared to Amlodipine Maleate in Patients With Essential Hypertension - Full Text View

Purpose

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	Intervention	Phase
Essential Hypertension	Drug: Levamlodipine besylate Drug: Amlodipine maleate	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Controlled, Multicenter Trial of Levamlodipine Besylate Versus Amlodipine Maleate in Patients With Essential Hypertension

Resource links provided by NLM:

Drug Information available for: Amlodipine Amlodipine besylate

U.S. FDA Resources

Further study details as provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:

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) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in systolic blood pressure (SBP) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Change from baseline in diastolic blood pressure (DBP) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Incidence of adverse effects [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	1080
Study Start Date:	December 2009
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information


Responsible Party:	Jinsheng Ren, Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
ClinicalTrials.gov Identifier:	NCT01131546 History of Changes
Other Study ID Numbers:	SIM-77
Study First Received:	May 25, 2010
Last Updated:	May 30, 2011
Health Authority:	China: The State Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 26, 2016