Lower Leg EdemaNCT02415192
Observational Study to Evaluate the Safety and Efficacy for Levacalm Tab. Versus Valsartan/Amlodipine Combination Therapy in Essential Hypertension Patients
An observational study of Lower Leg Edema and Orthostatic Hypertension, run by LG Life Sciences at 1 site in South Korea.
Trial summary
Levacalm Tab. was approved in Jul 2013 by MFDS in South Korea. Levacalm Tab. is combination drug of Valsartan as an angiotensin II receptor blocker and Lercanidipine as a Calcium channel blocker. It is a new drug of combination of Valsartan and Lercanidipine. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lower Leg Edema, Orthostatic Hypertension
- What is being tested?
- Levacalm and Valsartan/amlodipine
- How many people
- 2,001 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Nov 2016
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with essential hypertension
Who may be able to join
- patients aged over 19 with essential hypertension
- Those who meet the inclusion criteria, fall under any of the following 3 cases and determined by the investigator to be prescribed Levacalm or Valsartan/Amlodipine combination:
- those who can't maintain the blood pressure with the antihypertensive drug before.
- those who diagnosed to a hypertension stage 2.(DBP is higher than 160mmHg or SBP is higher than 100mmHg)
- those who fall under the following :cardiovascular disease, Cerebrovascular disease, chronic Renal disease, diabetes mellitus, peripheral vascular disease
- Those who were informed of the purpose, method, and effect etc. of this study and signed the informed consent form.
Who cannot join
- Those who are included in the contraindication of study drug following the information for use of the product
- Those who is/will be participated in other drug clinical trial
- Those who adminitrated other antihypertensive drugs beside the levacalm or Valsartan/amlodipine combination drug.
- Those who judged by the invesigator as ineligible for this clinical study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
LG Life Science
Seoul, Jongno gu, 110-783
Hye jin Yoon
About this study
Official title: A Multicenter, Prospective Observational Study to Evaluate the Safety and Efficacy for Levacalm Tab. Versus Valsartan/Amlodipine Combination Therapy in Patient With Essential Hypertension
Levacalm Tab. was approved in Jul 2013 by MFDS in South Korea. Levacalm Tab. is combination drug of Valsartan as an angiotensin II receptor blocker and Lercanidipine as a Calcium channel blocker. It is a new drug of combination of Valsartan and Lercanidipine. Thus, there's no enough safety data and efficacy data defined from the clinical study.
Also, many combination drugs of valsartaa and amlodipine are widely used in the market.
LGLS will compare the safety(adverse events especially the lower leg edema) and efficacy (blood pressure and pulse) of Levacalm and Valsartan/amlodipine combination drug from this study.
- Conditions
- Lower Leg Edema, Orthostatic Hypertension
- Being tested
- Levacalm, Valsartan/amlodipine
- Keywords
- safety data, hypertension therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevacalmDrug
Valsartan/amlodipineDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Levacalm | In this group, the patients will be enrolled treated with Levacalm tab. as an anti-hypertensive drug.
The number of this group will be double than the control group to get more information about safety and efficacy. Receives: Drug: Levacalm | |
| Patients treated with Valsartan/amlodipine | In this group, the patients will be enrolled treated with Valsartan/amlodipine combination drug as an anti-hypertensive drug. Receives: Drug: Valsartan/amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of each group by observing the Adverse events especially detecting the incidence of lower leg edema and orthostatic hypertension by subject questionnaire.
Measured: 6month
Secondary outcomes (5)
mean change of the blood pressure and pulse after administation of drug at 12week and 24week.
Measured: 12weeks, 24weeks
BP control rate
Measured: 12weeks, 24weeks
Responder rate
Measured: 12weeks, 24weeks
Evaluation of the changes in metabolic syndrome markers after treatment if the factors are available
Measured: 12weeks, 24weeks
Evaluation of cardiovascular risk
Measured: 12weeks, 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJul 2014
- Primary completionOct 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Leg EdemaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,001 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keun Soo Bang, Study director, LG Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415192
- Sponsor's protocol ID
- LG-ZVOS001
- Status last verified
- Apr 2016
- First submitted
- 8 Apr 2015
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Observational Study to Evaluate the Safety and Efficacy for Levacalm Tab. Versus Valsartan/Amlodipine Combination Therapy in Patient With Essential Hypertension
- ClinicalTrials.gov ID
- NCT02415192
- Acronym / sponsor ID
- LG-ZVOS001
- Conditions
- Lower Leg Edema, Orthostatic Hypertension
- Keywords
- safety data, hypertension therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,001 participants (estimated)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 14 Apr 2015 (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.
Levacalm Tab. was approved in Jul 2013 by MFDS in South Korea. Levacalm Tab. is combination drug of Valsartan as an angiotensin II receptor blocker and Lercanidipine as a Calcium channel blocker. It is a new drug of combination of Valsartan and Lercanidipine. Thus, there's no enough safety data and efficacy data defined from the clinical study.
Also, many combination drugs of valsartaa and amlodipine are widely used in the market.
LGLS will compare the safety(adverse events especially the lower leg edema) and efficacy (blood pressure and pulse) of Levacalm and Valsartan/amlodipine combination drug from this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Levacalm | – | Drug: LevacalmIn this group, the patients will be enrolled treated with Levacalm tab. as an anti-hypertensive drug. The number of this group will be double than the control group to get more information about safety and efficacy. |
| Patients treated with Valsartan/amlodipine | – | Drug: Valsartan/amlodipineIn this group, the patients will be enrolled treated with Valsartan/amlodipine combination drug as an anti-hypertensive drug. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with essential hypertension
Key inclusion criteria (6 listed)
- patients aged over 19 with essential hypertension
- Those who meet the inclusion criteria, fall under any of the following 3 cases and determined by the investigator to be prescribed Levacalm or Valsartan/Amlodipine combination:
- Those who were informed of the purpose, method, and effect etc. of this study and signed the informed consent form.
Key exclusion criteria (4 listed)
- Those who are included in the contraindication of study drug following the information for use of the product
- Those who is/will be participated in other drug clinical trial
- Those who adminitrated other antihypertensive drugs beside the levacalm or Valsartan/amlodipine combination drug.
- Those who judged by the invesigator as ineligible for this clinical 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 |
|---|---|---|
| Levacalm | Drug | Patients treated with Levacalm |
| Valsartan/amlodipine | Drug | Patients treated with Valsartan/amlodipine |
Primary outcome
Safety of each group by observing the Adverse events especially detecting the incidence of lower leg edema and orthostatic hypertension by subject questionnaire.
Time frame: 6month
5 secondary outcomes
mean change of the blood pressure and pulse after administation of drug at 12week and 24week.
Time frame: 12weeks, 24weeks
BP control rate
Time frame: 12weeks, 24weeks
Responder rate
Time frame: 12weeks, 24weeks
Evaluation of the changes in metabolic syndrome markers after treatment if the factors are available
Time frame: 12weeks, 24weeks
Evaluation of cardiovascular risk
Time frame: 12weeks, 24weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
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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.
Keun Soo Bang study director
LG Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Leg Edema and Orthostatic Hypertension, run by LG Life Sciences 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 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 19 Apr 2016. 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.
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 Hye Jin Yoon (82-2-6924-3148, hyejin0611@lgls.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of each group by observing the Adverse events especially detecting the incidence of lower leg edema and orthostatic hypertension by subject questionnaire. (time frame: 6month). 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 19 Apr 2016.