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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00338338
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : October 9, 2017
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Uncomplicated Hypertension Hypertension Essential Drug: Lacidipine 4 or 6 mg (oral) Drug: Amlodipine 5 or 10 mg(oral) Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 7, 2005
Actual Primary Completion Date : September 14, 2007
Actual Study Completion Date : September 14, 2007

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Lacidipine 4 or 6 mg (oral)
  • Drug: Amlodipine 5 or 10 mg(oral)
    Other Name: Lacidipine 4 or 6 mg (oral)

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  1. Patients previously untreated for hypertension;
  2. Intolerant or not responding to their current therapy;
  3. 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00338338

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GSK Investigational Site
Taipei, Taiwan, 100
Sponsors and Collaborators
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Study Director: GSK Clinical Trials, MD, PhD GlaxoSmithKline

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Responsible Party: GlaxoSmithKline Identifier: NCT00338338     History of Changes
Other Study ID Numbers: 106357
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Keywords provided by GlaxoSmithKline:
essential hypertension
blood pressure
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents