Effect of Lacidipine and Losartan on 24 Hour Systolic Blood Pressure Variability in Elderly Hypertensive Patients

Seoul National University

Status and phase

Unknown

Phase 4

Conditions

Hypertension

Treatments

Drug: lacidipine (4 mg) or losartan (50 mg)

Study type

Interventional

Funder types

Other

Identifiers

NCT00533858

06-2007-083

Details and patient eligibility

About

The aim of this study is to evaluate the effect of lacidipine and losartan in elderly hypertensive patients on reducing the 24 hour systolic BP variability, which is one of the potential parameter to consider in treating elderly hypertensive patients.

Full description

In this study, we investigate the effects of two anti-hypertensive medications on systolic BP variability profile as a pilot study. This is a prospective, randomized, open-label, blinded end point (PROBE), parallel group study with two treatment arms. At the end of an initial 2-week washout period, during which any eventual anti-hypertensive drug is discontinued, patients fulfilling the inclusion criteria are randomly treated with the lacidipine (4 mg) or losartan (50 mg), both given once daily at the same hour in the morning (approximately at 8 AM) for 12 weeks. If the BP goal (SBP < 140 mmHg and DBP < 90 mmHg) has not been attained after 4 week's treatment, 12.5 mg hydrochlorothiazide (HCTS) once daily can be added.

Patients are checked 24-h ambulatory BP monitoring (ABPM) at the end of the washout period and after 12 weeks of active treatment. At each visit, seated cuff SBP and DBP, heart rate, use of concomitant medication and spontaneously reported adverse events are recorded.

Enrollment

160 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Elderly patients (age > 65 years)
Essential hypertension (systolic BP > 140 mmHg or diastolic BP > 90 mm Hg)
Provide written informed content

Exclusion criteria

Secondary hypertension
Myocardial infarction or cerebrovascular accident within the preceding 6 months
Clinically significant valvular heart disease, heart failure (Class III, IV), renal insufficiency (serum creatinine > 2.5mg/dl), hepatic failure, uncontrolled diabetes mellitus
Known hypersensitivity to the drugs used in the study.