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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00338338
• Other study ID #: 106357
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2006
• Last updated: October 5, 2017
• Start date: November 7, 2005
• Est. completion date: September 14, 2007

Study information

• Verified date: October 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 14, 2007
• Est. primary completion date: September 14, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential
• Hypertension
• Uncomplicated Hypertension

Intervention

Drug:
• Lacidipine 4 or 6 mg (oral)

• Amlodipine 5 or 10 mg(oral)

Locations

Country	Name	City	State
Taiwan	GSK Investigational Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.