HypertensionPhase 4NCT00533858
Effect of Lacidipine and Losartan on 24 Hour Systolic Blood Pressure Variability in Elderly Hypertensive Patients
A Phase 4 study testing lacidipine (4 mg) or losartan (50 mg) in people with Hypertension, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- lacidipine (4 mg) or losartan (50 mg)
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2007to Sep 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
Who may be able to join
- Elderly patients (age > 65 years)
- Essential hypertension (systolic BP > 140 mmHg or diastolic BP > 90 mm Hg)
- Provide written informed content
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Kyeonggi, 463-707
Cheol-Ho Kim, MD, PhD, 82-31-787-7001, cheolkim@snu.ac.kr
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- lacidipine (4 mg) or losartan (50 mg)
- Keywords
- Systolic hypertension
- Medical subject headings
- Hypertension, Isolated Systolic Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study startSep 2007
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Cheol-Ho Kim, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533858
- Sponsor's protocol ID
- 06-2007-083
- Status last verified
- Oct 2008
- First submitted
- 21 Sep 2007
- Last updated
- 21 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lacidipine and Losartan on 24 Hour Systolic Blood Pressure Variability in Elderly Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00533858
- Acronym / sponsor ID
- 06-2007-083
- Conditions
- Hypertension
- Keywords
- Systolic hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Study completion
- Sep 2008 (estimated)
- First posted
- 24 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Elderly patients (age > 65 years)
- Essential hypertension (systolic BP > 140 mmHg or diastolic BP > 90 mm Hg)
- Provide written informed content
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | – |
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
8 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2008.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheol-Ho Kim, MD, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lacidipine (4 mg) or losartan (50 mg) in people with Hypertension, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheol-Ho Kim, MD, PhD (82-31-787-7001, cheolkim@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2008.