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

NCT00338338 | Completed Phase 4

• 1 other identifier: 106357
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Uncomplicated Hypertension; Hypertension; Essential

Keywords

essential hypertension; Amlodipine; blood pressure; lacidipine

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• 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.

Interventions

Lacidipine 4 or 6 mg (oral) DRUG

Amlodipine 5 or 10 mg(oral) DRUG

Also known as: Lacidipine 4 or 6 mg (oral)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• GSK Clinical Trials, MD, PhD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2006
• First Posted: June 20, 2006
• Study Start: November 7, 2005
• Primary Completion: September 14, 2007
• Study Completion: September 14, 2007
• Last Updated: October 9, 2017

Record last verified: 2017-10

Locations

TW (1)