Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-03-12 @ 6:55 AM
Study NCT ID:
NCT00533858
Status:
UNKNOWN
Last Update Posted:
2008-10-21
First Post:
2007-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Lacidipine and Losartan on 24 Hour Systolic Blood Pressure Variability in Elderly Hypertensive Patients
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2008-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: