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

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ClinicalTrials.gov Identifier: NCT00533858
Recruitment Status : Unknown
Verified October 2008 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : September 24, 2007
Last Update Posted : October 21, 2008
Sponsor:
Information provided by:
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: lacidipine (4 mg) or losartan (50 mg) Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2007
Estimated Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: 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


Primary Outcome Measures :
  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 Outcome Measures :
  1. 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
  2. The difference of the changes in office diastolic and systolic BP after 12 weeks' treatment between lacidipine group and losartan group
  3. The difference of the mean 24-hour ABPM systolic and diastolic BP after 12 weeks' treatment between lacidipine group and losartan group
  4. The difference of the diastolic and systolic BP control rates after treatment between the 2 groups
  5. The difference of the changes in 24-hour, one day BP standard deviation (SD) within subjects between lacidipine group and losartan group
  6. 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
  7. 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
  8. The difference of the changes in pulse pressure after treatment between the 2 groups


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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533858


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

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Kyeonggi, Korea, Republic of, 463-707
Contact: Cheol-Ho Kim, MD, PhD    82-31-787-7001    cheolkim@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Cheol-Ho Kim, MD, PhD Seoul National University Bundang Hospital

ClinicalTrials.gov Identifier: NCT00533858     History of Changes
Other Study ID Numbers: 06-2007-083
First Posted: September 24, 2007    Key Record Dates
Last Update Posted: October 21, 2008
Last Verified: October 2008

Keywords provided by Seoul National University Hospital:
Systolic hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Lacidipine
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators