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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00338338
First received: June 16, 2006
Last updated: May 26, 2011
Last verified: May 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 70
Study Start Date: November 2005
Intervention Details:
    Drug: Lacidipine 4 or 6 mg (oral) Drug: Amlodipine 5 or 10 mg(oral)
    Other Names:
    • Amlodipine 5 or 10 mg(oral)
    • Lacidipine 4 or 6 mg (oral)
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338338

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00338338     History of Changes
Other Study ID Numbers: 106357
Study First Received: June 16, 2006
Last Updated: May 26, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by GlaxoSmithKline:
essential hypertension
Amlodipine
blood pressure
lacidipine

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lacidipine
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on August 20, 2014