- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00533858
Effect of Lacidipine and Losartan on 24 Hour Systolic Blood Pressure Variability in Elderly Hypertensive Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Cheol-Ho Kim, MD, PhD
- Phone Number: 82-31-787-7001
- Email: cheolkim@snu.ac.kr
Study Locations
-
-
Kyeonggi
-
Seongnam, Kyeonggi, Korea, Republic of, 463-707
- Recruiting
- Seoul National University Bundang Hospital
-
Contact:
- Cheol-Ho Kim, MD, PhD
- Phone Number: 82-31-787-7001
- Email: cheolkim@snu.ac.kr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome 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 Outcome Measures
Outcome 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
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Cheol-Ho Kim, MD, PhD, Seoul National University Bundang Hospital
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Losartan
- Lacidipine
Other Study ID Numbers
- 06-2007-083
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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