Status:
COMPLETED
The Efficacy And Safety Of Lacidipine And Amlodipine Once-Daily Treatment In Hypertensive Adult Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Uncomplicated Hypertension
Hypertension
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
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 blocke...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 7 2005
Trial Type :
INTERVENTIONAL
End Date :
September 14 2007
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00338338
Start Date
November 7 2005
End Date
September 14 2007
Last Update
October 9 2017
Active Locations (1)
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1
GSK Investigational Site
Taipei, Taiwan, 100