HypertensionPhase 4NCT01830517
Diurnal Variation in Hypertensive Stroke Patients
A Phase 4 study testing Amlodipine, Losartan in people with Hypertension and Stroke, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
This study was conducted to evaluate and compare the effectiveness of Amodipin® (amlodipine camsylate) with that of Cozaar® (losartan potassium) in hypertensive patients with an acute ischemic stroke by measuring their 24-hour ambulatory BP (ABP). Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Hypertension, Stroke
- What is being tested?
- Amlodipine, Losartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2007to Feb 2012
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 35 to 85 years
- hypertensive patients who had an ischemic stroke
Who cannot join
- patients aged below 35 years or above 86 years;
- patients who had a hemorrhagic stroke;
- patients whose systolic BP (SBP) was over 220 mmHg or whose diastolic BP (DBP) was above 120 mmHg during an acute phase, or whose SBP was over 180 mmHg or whose DBP was over 110 mmHg one week after their hospital visit;
- patients with secondary hypertension related to renovascular, endocrinologic, or pregnant conditions
- patients who went to bed in the middle of the day or very late at night; (6) patients who were using intravenous antico-agulants or thrombolytics;
- patients with a severe stroke (NIH stroke scale > 20); (8) patients who could not give their consent to investigators; (9) patients with severely impaired liver function (AST or ALT ≥ 100); (10) patients with severely impaired renal function (serum creatinine ≥ 2.0 mg/dL); (11) patients with cancer; (12) patients who were pregnant or lactating; (13) patients with other grave diseases such as hypertensive encephalopathy, aortic dissection, acute myocardial infarction, or severe congestive heart failure; and (14) patients who were allergic to the test or control drugs
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Boramae Medical Center
Boramae-ro 5-gil 20, Dongjak-gu, Seoul, 156-707
About this study
Official title: Comparison of the Effects of Amlodipine and Losartan on Blood Pressure and Diurnal Variation in Hypertensive Stroke Patients
This study was conducted to evaluate and compare the effectiveness of Amodipin® (amlodipine camsylate) with that of Cozaar® (losartan potassium) in hypertensive patients with an acute ischemic stroke by measuring their 24-hour ambulatory BP (ABP).
- Conditions
- Hypertension, Stroke
- Being tested
- Amlodipine, Losartan
- Medical subject headings
- Hypertension, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine, LosartanDrug
| Study group | Role | What they receive |
|---|---|---|
| amlodipine camsylate | Experimental | amlodipine camsylate 5mg Receives: Drug: Amlodipine, Losartan |
| losartan potassium | Active comparator | losartan potassium 50mg Receives: Drug: Amlodipine, Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour ambulatory mean SBP
Measured: baseline and 8weeks
Secondary outcomes (1)
24H mean DBP, 24H mean SBP/DBP Variability,clinic SBP/DBP, awake, sleep, morning, evening, and prewake BPs, the morning surge, and the nocturnal dipping
Measured: baseline and 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startAug 2007
- Primary completionJun 2011
- Study completionFeb 2012
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.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyunwoo Nam, M.D., Ph.D., Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830517
- Sponsor's protocol ID
- HM-AMO-401
- Status last verified
- Apr 2013
- First submitted
- 10 Apr 2013
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kwon HM, Shin JW, Lim JS, Hong YH, Lee YS, Nam H. Comparison of the effects of amlodipine and losartan on blood pressure and diurnal variation in hypertensive stroke patients: a prospective, randomized, double-blind, comparative parallel study. Clin Ther. 2013 Dec;35(12):1975-82. doi: 10.1016/j.clinthera.2013.10.013. Epub 2013 Dec 2.
PubMed 24296324
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Amlodipine and Losartan on Blood Pressure and Diurnal Variation in Hypertensive Stroke Patients
- ClinicalTrials.gov ID
- NCT01830517
- Acronym / sponsor ID
- HM-AMO-401
- Conditions
- Hypertension, Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 12 Apr 2013 (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.
This study was conducted to evaluate and compare the effectiveness of Amodipin® (amlodipine camsylate) with that of Cozaar® (losartan potassium) in hypertensive patients with an acute ischemic stroke by measuring their 24-hour ambulatory BP (ABP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amlodipine camsylate | Experimental | Drug: Amlodipine, Losartanamlodipine camsylate 5mg |
| losartan potassium | Active comparator | Drug: Amlodipine, Losartanlosartan potassium 50mg |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 35 to 85 years
- hypertensive patients who had an ischemic stroke
Key exclusion criteria (6 listed)
- patients aged below 35 years or above 86 years;
- patients who had a hemorrhagic stroke;
- patients whose systolic BP (SBP) was over 220 mmHg or whose diastolic BP (DBP) was above 120 mmHg during an acute phase, or whose SBP was over 180 mmHg or whose DBP was over 110 mmHg one week after their hospital visit;
- patients with secondary hypertension related to renovascular, endocrinologic, or pregnant conditions
- patients who went to bed in the middle of the day or very late at night; (6) patients who were using intravenous antico-agulants or thrombolytics;
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 |
|---|---|---|
| Amlodipine, Losartan | Drug | amlodipine camsylate, losartan potassium |
Primary outcome
24-hour ambulatory mean SBP
Time frame: baseline and 8weeks
1 secondary outcome
24H mean DBP, 24H mean SBP/DBP Variability,clinic SBP/DBP, awake, sleep, morning, evening, and prewake BPs, the morning surge, and the nocturnal dipping
Time frame: baseline and 8weeks
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 12 Apr 2013.
- Derived from this study: PubMed 24296324Kwon HM, Shin JW, Lim JS, Hong YH, Lee YS, Nam H. Comparison of the effects of amlodipine and losartan on blood pressure and diurnal variation in hypertensive stroke patients: a prospective, randomized, double-blind, comparative parallel study. Clin Ther. 2013 Dec;35(12):1975-82. doi: 10.1016/j.clinthera.2013.10.013. Epub 2013 Dec 2.
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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.
Hyunwoo Nam, M.D., Ph.D. principal investigator
SMG-SNU Boramae Medical Center
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 Amlodipine, Losartan in people with Hypertension and Stroke, run by Hanmi Pharmaceutical Company Limited 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 2 inclusion and 6 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 12 Apr 2013. 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?
24-hour ambulatory mean SBP (time frame: baseline and 8weeks). 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 NCT01830517, 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 12 Apr 2013.