Last updated: 11/03/2018 08:47:22
The Efficacy And Safety Of Lacidipine And Amlodipine Once-Daily Treatment In Hypertensive Adult Patients
GSK study ID
106357
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Lacidipine 4 or 6 mg (oral)
Drug: Amlodipine 5 or 10 mg(oral)
Enrollment:
70
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Uncomplicated Hypertension, Essential
Product
lacidipine
Collaborators
Not applicable
Study date(s)
November 2005 to September 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
- Informed consent written prior to the recruit into the study
- Male or female subjects
- Any form of secondary hypertension
- History of malignant hypertension or evidence of accelerated hypertension
Inclusion and exclusion 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
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-14-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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