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Efficacy and Safety of Levamlodipine Besylate Compared to Amlodipine Maleate in Patients With Essential Hypertension
This study has been completed.
Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
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
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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 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 ]
Secondary Outcome Measures:
- Change from baseline in systolic blood pressure (SBP) [ Time Frame: Week 8 ]
- Change from baseline in diastolic blood pressure (DBP) [ Time Frame: Week 8 ]
- Incidence of adverse effects [ Time Frame: 8 weeks ]
| 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) |
| 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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01131546
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 |
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 July 24, 2017