Clinical trial NCT00533858: Effect of Lacidipine and Losartan on 24 Hour Systolic Blood Pressure Variability in Elderly Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Keywords: Systolic hypertension
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2007-09-24
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change of 24-hour, one day systolic BP standard deviation (SD) within subjects (the difference of SD before and after 12 weeks' treatment) in lacidipine group and losartan group
Secondary outcomes:
measure: The change of 24-hour, one day diastolic BP standard deviation (SD) within subjects (the difference of SD before and after 12 weeks' treatment) in lacidipine group and losartan group
measure: The difference of the changes in office diastolic and systolic BP after 12 weeks' treatment between lacidipine group and losartan group
measure: The difference of the mean 24-hour ABPM systolic and diastolic BP after 12 weeks' treatment between lacidipine group and losartan group
measure: The difference of the diastolic and systolic BP control rates after treatment between the 2 groups
measure: The difference of the changes in 24-hour, one day BP standard deviation (SD) within subjects between lacidipine group and losartan group
measure: The difference of the variation of coefficient (CV) of the mean values (24-hour BP SD divided by the mean multiplied by 100) between 2 groups
measure: The difference of the smoothness index (SI, dividing the average of the 24 hourly change after treatment by the corresponding standard deviation) between 2 groups
measure: The difference of the changes in pulse pressure after treatment between the 2 groups
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Cheol-Ho Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: