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
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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 |

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 |
- 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 ]
- 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 ]

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

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
China | |
Peking University People's Hospital | |
Beijing, China |
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 |
Other Study ID Numbers: |
SIM-77 |
First Posted: | May 27, 2010 Key Record Dates |
Last Update Posted: | June 1, 2011 |
Last Verified: | May 2011 |
Essential Hypertension Levamlodipine Besylate Amlodipine Maleate |
Hypertension Essential Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Antihypertensive Agents |
Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents |