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NCT Number: NCT00338338

The Efficacy And Safety Of Lacidipine And Amlodipine Once-Daily Treatment In Hypertensive Adult Patients

The sustained reduction in elevated blood pressure and lower incidence of adverse events of Lacidipine may provide additional benefits for hypertension patients than other CCBs (calcium channel blockers). This study is to compare the efficacy and safety of Lacidipine with Amlodipine, the most widely used CCB in Taiwan, in hypertensive patients.

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Key information

Conditions

Uncomplicated Hypertension Cardiovascular Diseases Essential Essential Hypertension Hypertension Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent written prior to the recruit into the study
  • Male or female subjects
  • Patients with diagnosis of essential, uncomplicated hypertension
  • After one to two weeks washout period, patients showing, systolic blood pressure equal or lager than 160mmHg or diastolic blood pressure equal or lager than 90mmHg

Subject could be enrolled in one of the following state:

  • Patients previously untreated for hypertension;
  • Intolerant or not responding to their current therapy;
  • Patients controlled under their previous therapy but who can safely and agree to be switched to the trial therapy could clinically feasible for mono-therapy for hypertension control.

Exclusion criteria

  • Any form of secondary hypertension
  • History of malignant hypertension or evidence of accelerated hypertension
  • Myocardial infarction within 3 months
  • Unstable angina pectoris
  • Congestive heart failure
  • Atrial fibrillation
  • Life threatening arrhythmia
  • History of cerebrovascular accident
  • Clinically relevant renal disease; defines if serum creatinine equal or lager than 1.5 mg/dl
  • Liver function abnormal: glutamic-oxalacetic transaminase lager than 2 times of upper limit normal or glutamic-pyruvic transaminase lager than 2 times of upper limit normal
  • Existence of any serious systemic disease
  • Allergic history to the compounds of both study medication
  • Can not comply the study protocol or misunderstand the informed consent form
  • Other diseases which treated by calcium channel blockers

Treatment and study plan

Lacidipine 4 or 6 mg (oral)

Drug

Amlodipine 5 or 10 mg(oral)

Drug

Other names: Lacidipine 4 or 6 mg (oral)

Primary outcomes

  1. To evaluate the efficacy of of Lacidipine 4 or 6 mg and Amlodipine 5 or 10 mg on blood pressure profiles, in terms of blood pressure, heart rate, and edema after 8 weeks of treatment.

Secondary outcomes

  1. To compare the overall safety profile of Lacidipine and Amlodipine, in terms of percentage and types of adverse events reported after 8 weeks of treatment.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Randomized, Double-blind, Parallel Group, Single-Centre Study to Evaluate the Efficacy and Safety of Lacidipine and Amlodipine Once-daily Treatment in Hypertensive Adult Patients

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jun 20, 2006
Registry last updated
Oct 9, 2017

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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