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NCT Number: NCT01131546

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

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University People's Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levamlodipine besylate

Drug

Once daily, 7AM - 10AM

Amlodipine maleate

Drug

Once daily, 7AM - 10AM

Primary outcomes

  1. 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 outcomes

  1. Change from baseline in systolic blood pressure (SBP)

    Time frame: Week 8

  2. Change from baseline in diastolic blood pressure (DBP)

    Time frame: Week 8

  3. Incidence of adverse effects

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 27, 2010
Registry last updated
Jun 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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