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

Condition(s) targeted: Hypertension

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

Phase: Phase 4

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Cheol-Ho Kim, MD, PhD, Principal Investigator, Affiliation: Seoul National University Bundang Hospital

Overall contact:
Cheol-Ho Kim, MD, PhD, Phone: 82-31-787-7001, Email: cheolkim@snu.ac.kr

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.

Study design: Treatment, Randomized, Open Label, Parallel Assignment

Primary outcome: 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 outcome:

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

The difference of the changes in office diastolic and systolic BP after 12 weeks' treatment between lacidipine group and losartan group

The difference of the mean 24-hour ABPM systolic and diastolic BP after 12 weeks' treatment between lacidipine group and losartan group

The difference of the diastolic and systolic BP control rates after treatment between the 2 groups

The difference of the changes in 24-hour, one day BP standard deviation (SD) within subjects between lacidipine group and losartan group

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

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

The difference of the changes in pulse pressure after treatment between the 2 groups

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.

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

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.

Cheol-Ho Kim, MD, PhD, Phone: 82-31-787-7001, Email: cheolkim@snu.ac.kr

Seoul National University Bundang Hospital, Seongnam, Kyeonggi 463-707, Korea, Republic of; Recruiting
Cheol-Ho Kim, MD, PhD, Phone: 82-31-787-7001, Email: cheolkim@snu.ac.kr

Starting date: September 2007
Ending date: September 2008
Last updated: October 18, 2008