HypertensionPhase 4ELDERNCT00460915
Efficacy and Safety of Lacidipine and Amlodipine on Blood Pressure in Korean ISH Patients Aged 60 to 80 Years
A Phase 4 study testing Lacidipine & Amlodipine in people with Hypertension, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
Primary Objective -To investigate the clinical effectiveness of lacidipine and amlodipine on systolic blood pressure (SBP) in Korean ISH patients aged 60 to 80 years. Secondary Objectives -To investigate the clinical effectiveness of lacidipine and amlodipine on diastolic blood pressure (DBP) in Korean ISH patients… Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Lacidipine & Amlodipine
- How many people
- 204 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2007to Feb 2010
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 55 to 80 years of age at screening
- The subject has been newly diagnosed as essential hypertension or not treated in the past 2 weeks. If the subject took medication in the past 2 weeks, a wash-out period of at least 2 weeks will be completed prior to performing screening (week -2) assessments
- The subject has a mean seated SBP at screening visit ≥ 140mmHg (as measured by a mercury sphygmomanometer)
- Isolated systolic hypertension (ISH) patient (SBP≥ 140mmHg, DBP ≤90mmHg)
- If the subject is a female of child-bearing potential, she agrees to practice acceptable contraceptive measures during the study, and for 30 days after the last dose of study medication is taken
- The subject has given written informed consent
Who cannot join
- A subject will not be eligible for inclusion in this study if any of the following criteria apply :
- Mean seated SBP of > 180 mmHg at screening and during the study
- Known or suspected secondary hypertension
- The subject has anemia defined by hemoglobin concentration < 10.0 g/dL for male or female
- The subject has a hemoglobinopathy or peripheral vascular disease
- The subject has presence of clinically significant renal or hepatic disease (i.e., subjects with serum creatinine > 1.4 mg/dL;ALT, AST, total bilirubin, or alkaline phosphatase > 2.5 times the upper limit of the normal (ULN) reference range
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- The subject has presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring pharmacologic treatment
- The subject has a chronic disease requiring intermittent or chronic treatment with oral, intravenous, or intra-articular corticosteroids (i.e., only use of topical, inhaled or nasal corticosteroids is permissible)
- The subject has a clinically significant abnormality identified at screening which in the judgement of the investigator makes the subject unsuitable for inclusion in the study (e.g. physical examination, or electrocardiogram etc.)
- Past medical history or concomitant disease of metabolic acidosis or diabetic ketoacidosis
- The subject has a diagnosis of cancer (other than squamous or basal cell) in the past 3 years and is currently receiving treatment for the active cancer
- Subject who is taking medication known to affect blood pressure
- Known drug or alcohol dependency within 6 months prior to screening as determined by the investigator
- Has taken part in a clinical trial using a marketed product, investigational drug or device within 1 month prior to screening.
- Hypersensitivity to any component of lacidipine and amlodipine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Korea University Guro Hospital
Primary Objective -To investigate the clinical effectiveness of lacidipine and amlodipine on systolic blood pressure (SBP) in Korean ISH patients aged 60 to 80 years.
Secondary Objectives -To investigate the clinical effectiveness of lacidipine and amlodipine on diastolic blood pressure (DBP) in Korean ISH patients aged 60 to 80 years
To demonstrate the effectiveness of lacidipine and amlodipine on endothelial function through measurement of markers of inflammation.
Read the detailed description
Patients will receive lacidipine 4mg and amlodipine 5mg for initial 4 weeks. If SBP is less than 140mmHg at Week 4, subjects continue to take lacidipine 4mg and amlodipine 5mg.
If SBP is ≥140mmHg at Week 4, the dose of lacidipine will be increased to 6mg and amlodipine will be increased to 10mg.
If BP is not controlled under 140mmHg at Week 8, diuretics will be added. For 12 weeks of treatment period, subjects will be visit to clinic at every 4 weeks
- Conditions
- Hypertension
- Being tested
- Lacidipine & Amlodipine
- Keywords
- Lacidipine, Amlodipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacidipine & AmlodipineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the mean SBP at week 12
Secondary outcomes (2)
Change from baseline in the mean DBP at week 12
Change from baseline in the CRP at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startJan 2007
- Primary completionJul 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Hong-seog Seo, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460915
- Sponsor's protocol ID
- COL109776
- Acronym
- ELDER
- Status last verified
- Nov 2009
- First submitted
- 16 Apr 2007
- Last updated
- 2 Mar 2010
- Results posted
- No
Publications
Na JO, Seo HS, Choi CU, Lim HE, Kim JW, Kim EJ, Han SW, Rha SW, Park CG, Oh DJ; ELDER investigators. Results of a 14-Week, Multicenter, Prospective, Randomized, Open-Label, Noninferiority Clinical Trial Comparing the Antihypertensive Effect and Edema Incidence of Lacidipine and Amlodipine in Older Korean Patients with Mild-to-Moderate Hypertension. Curr Ther Res Clin Exp. 2013 Jun;74:54-61. doi: 10.1016/j.curtheres.2013.02.001.
PubMed 24384734
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korea University Guro Hospital
- ClinicalTrials.gov ID
- NCT00460915
- Acronym / sponsor ID
- ELDER / COL109776
- Conditions
- Hypertension
- Keywords
- Lacidipine, Amlodipine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 17 Apr 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.
Primary Objective -To investigate the clinical effectiveness of lacidipine and amlodipine on systolic blood pressure (SBP) in Korean ISH patients aged 60 to 80 years.
Secondary Objectives -To investigate the clinical effectiveness of lacidipine and amlodipine on diastolic blood pressure (DBP) in Korean ISH patients aged 60 to 80 years
To demonstrate the effectiveness of lacidipine and amlodipine on endothelial function through measurement of markers of inflammation.
Detailed description
Patients will receive lacidipine 4mg and amlodipine 5mg for initial 4 weeks. If SBP is less than 140mmHg at Week 4, subjects continue to take lacidipine 4mg and amlodipine 5mg.
If SBP is ≥140mmHg at Week 4, the dose of lacidipine will be increased to 6mg and amlodipine will be increased to 10mg.
If BP is not controlled under 140mmHg at Week 8, diuretics will be added. For 12 weeks of treatment period, subjects will be visit to clinic at every 4 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female 55 to 80 years of age at screening
- The subject has been newly diagnosed as essential hypertension or not treated in the past 2 weeks. If the subject took medication in the past 2 weeks, a wash-out period of at least 2 weeks will be completed prior to performing screening (week -2) assessments
- The subject has a mean seated SBP at screening visit ≥ 140mmHg (as measured by a mercury sphygmomanometer)
- Isolated systolic hypertension (ISH) patient (SBP≥ 140mmHg, DBP ≤90mmHg)
- If the subject is a female of child-bearing potential, she agrees to practice acceptable contraceptive measures during the study, and for 30 days after the last dose of study medication is taken
Key exclusion criteria (15 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply :
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 & Amlodipine | Drug | – |
Primary outcome
Change from baseline in the mean SBP at week 12
2 secondary outcomes
Change from baseline in the mean DBP at week 12
Change from baseline in the CRP at week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
- Derived from this study: PubMed 24384734Na JO, Seo HS, Choi CU, Lim HE, Kim JW, Kim EJ, Han SW, Rha SW, Park CG, Oh DJ; ELDER investigators. Results of a 14-Week, Multicenter, Prospective, Randomized, Open-Label, Noninferiority Clinical Trial Comparing the Antihypertensive Effect and Edema Incidence of Lacidipine and Amlodipine in Older Korean Patients with Mild-to-Moderate Hypertension. Curr Ther Res Clin Exp. 2013 Jun;74:54-61. doi: 10.1016/j.curtheres.2013.02.001.
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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.
Hong-seog Seo principal investigator
Korea University Guro 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 & Amlodipine in people with Hypertension, run by Korea University Guro 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 6 inclusion and 15 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: finished, as of the sponsor's last update on 2 Mar 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the mean SBP at week 12. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00460915, which also lists 1 linked publication.
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 2 Mar 2010.