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

NCT00533858 | Unknown Phase 4 DMC

• 1 other identifier: 06-2007-083
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Systolic hypertension

Outcome Measures

Primary Outcomes (1)

• 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 (8)

• 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

Interventions

lacidipine (4 mg) or losartan (50 mg) DRUG

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Kyeonggi, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Hypertension; Isolated Systolic Hypertension

Interventions

lacidipine; Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Essential Hypertension

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Cheol-Ho Kim, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheol-Ho Kim, MD, PhD

CONTACT

82-31-787-7001; cheolkim@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2007
• First Posted: September 24, 2007
• Study Start: September 1, 2007
• Study Completion: September 1, 2008
• Last Updated: October 21, 2008

Record last verified: 2008-10

Locations

KR (1)