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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Hypertension

Essential

Uncomplicated Hypertension

Treatments

Drug: Lacidipine 4 or 6 mg (oral)

Drug: Amlodipine 5 or 10 mg(oral)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00338338

106357

Details and patient eligibility

About

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.

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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