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

NCT ID: NCT00533858

Last Updated: 2008-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-09-30

Brief Summary

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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

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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.

Conditions

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Hypertension

Keywords

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Systolic hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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lacidipine (4 mg) or losartan (50 mg)

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Cheol-Ho Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, Kyeonggi, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Cheol-Ho Kim, MD, PhD

Role: CONTACT

Phone: 82-31-787-7001

Email: [email protected]

Facility Contacts

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Cheol-Ho Kim, MD, PhD

Role: primary

Other Identifiers

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06-2007-083

Identifier Type: -

Identifier Source: org_study_id