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

This study has been completed.
Sponsor:
Information provided by:
Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01131546
First received: May 25, 2010
Last updated: May 30, 2011
Last verified: May 2011
  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:


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
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

No publications provided

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
Cardiovascular Diseases
Vascular Diseases
Amlodipine
Maleic acid
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014