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

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00338338

First received: June 16, 2006

Last updated: May 26, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 16, 2006

Last Updated Date

May 26, 2011

Start Date ^ICMJE

November 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00338338 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Uncomplicated Hypertension
Hypertension
Essential

Intervention ^ICMJE

Drug: Lacidipine 4 or 6 mg (oral)
Drug: Amlodipine 5 or 10 mg(oral)
Other Names:
- Amlodipine 5 or 10 mg(oral)
- Lacidipine 4 or 6 mg (oral)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT00338338

Other Study ID Numbers ^ICMJE

106357

Has Data Monitoring Committee

Responsible Party

Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD, PhD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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