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

Essential Hypertension Clinical Trial

Official title:

A Randomized, Controlled, Multicenter Trial of Levamlodipine Besylate Versus Amlodipine Maleate in Patients With Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131546
• Other study ID #: SIM-77
• Status: Completed
• Phase: Phase 4
• First received: May 25, 2010
• Last updated: May 30, 2011
• Start date: December 2009
• Est. completion date: March 2011

Study information

• Verified date: May 2011
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: The State Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1080
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Levamlodipine besylate
Once daily, 7AM - 10AM
• Amlodipine maleate
Once daily, 7AM - 10AM

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Week 8	No
Secondary	Change from baseline in systolic blood pressure (SBP)		Week 8	No
Secondary	Change from baseline in diastolic blood pressure (DBP)		Week 8	No
Secondary	Incidence of adverse effects		8 weeks	Yes