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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00338338

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

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Lacidipine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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:	September 2005

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:

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

Contacts and Locations

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

Locations

Taiwan
GSK Clinical Trials Call Center
Taipei, Taiwan, 100

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD, PhD

GlaxoSmithKline

More Information

Study ID Numbers:	106357
Study First Received:	June 16, 2006
Last Updated:	November 8, 2007
ClinicalTrials.gov Identifier:	NCT00338338
Health Authority:	Taiwan: Department of Health

Keywords provided by GlaxoSmithKline:

essential hypertension
lacidipine
Amlodipine
blood pressure

Study placed in the following topic categories:

Calcium, Dietary
Lacidipine
Vascular Diseases

Essential hypertension
Amlodipine
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Calcium Channel Blockers

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009