Clinical trial NCT00338338: The Efficacy And Safety Of Lacidipine And Amlodipine Once-Daily Treatment In Hypertensive Adult Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uncomplicated Hypertension
Hypertension
Essential
Keywords: essential hypertension
Amlodipine
blood pressure
lacidipine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-20
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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:
measure: 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.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD, PhD
role: STUDY_DIRECTOR
References: