Essential HypertensionNCT04554303
Comparing Safety and Efficacy of Amlodipine Verses S Amlodipine in Patients With Essential Hypertension
An observational study of Essential Hypertension, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 1 site in South Korea.
Trial summary
As a third-generation dihydropyridine calcium channel blocker (CCB), Amlodipine is mainly used in a single therapy or combined therapy for hypertension or angina. Edema, one of the most common side effects of dihydropyridine CCB formulations, may lead to drug control or discontinuation of drugs. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- S-amlodipine 2.5mg and Amlodipine 5mg
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Oct 2020to 23 May 2022
- 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: Ordinary patients with essential hypertension who visits the medical institution participating in this study, and volunteers to enroll in this study.
Who may be able to join
- Patients with essential hypertension and diagnosed with stage 1-2 hypertension in accordance with the 2019 Korean Society of Hypertension criteria (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg)
- Where a subject and his/her spouse (partner) have agreed to use medically acceptable contraceptives in the following during participation in this clinical study:
- Use of intrauterine device with proven failure rate of pregnancy;
- Simultaneous use of blocking contraception and spermicide;
- Has had a vasectomy;
- Has had a salpingectomy, tubal ligation, or hysterectomy;
- Those who have made voluntary decisions to participate in this clinical study and have consented to the Informed Consent Form in writing;
- Those who are able to understand and follow instructions and participate throughout the entire clinical study
Who cannot join
- Patients with uncontrolled, high-risk hypertension (SBP≥180mm Hg and DBP≥110mm Hg);
- Those who have a history of secondary hypertension and any history of suspected secondary hypertension (aortic congestion, hyperaldosteronism, renal artery stenosis, Cushing's disease, chromaffinoma, polycystic renal disease, etc.);
- Those who fall under one or more of the following items that may cause edema without underlying diseases:
- Those who have been diagnosed with myocardial infarction or heart failure within 6 months of screening;
- Those who have been diagnosed with a cerebrovascular accident (CVA) within 6 months of screening;
- Patients with renal failure requiring dialysis or those with edema caused by renal dysfunction (renal salt retention);
Show all 30Show fewer
- Those who have uncontrolled diabetes (HbA1c> 10.0%) or diabetic edema;
- Patients with severe liver dysfunction or edema caused by liver disease (cirrhosis);
- Other patients with hypothyroidism, proteinuria, and problems at the joint or ankle joint
- Those who have cerebrovascular disease, unstable angina, or transient ischemic attack, or those who have had coronary artery bypass graft or coronary angioplasty;
- Patients who may develop edema by concomitant drugs at screening:
- Drugs that constrict intrarenal blood vessels (e.g. nonsteroidal anti-inflammatory drugs, cyclosporine, etc.);
- Drugs that dilate arterioles (e.g. vasodilators, etc.);
- Drugs that increase sodium reabsorption in the kidneys (e.g. steroids, etc.);
- Drugs that damage capillaries (e.g. interleukin-2, etc.);
- Glitazone-based drugs for diabetes
- Those who show hypersensitive reaction* to the investigational product;
- Those who are taking the following drugs that may cause drug interactions:
- Drugs that may change the plasma concentration of amlodipine [e.g. CYP3A4 inducers (e.g. rifampicin, St. John's wort (Hypericum perforatum), etc.);
- Drugs that may increase the antihypertensive action [e.g. other antihypertensives (calcium channel blockers, beta blockers, ACEi, ARB, alpha blockers, diuretics, nitroglycerin), tricyclic antidepressants (amitriptyline, desipramine, imipramine, nortriptyline, protriptyline, trimipramine, etc.), nitrate formulation, baclofen, pioglitazone, sildenafil, etc.];
- Systemic corticosteroids (fluocinolone, triamcinolone), etc.: Local application allowed;
- Drugs that may increase the inhibitory action of muscle contraction [e.g. antiarrhythmics (amiodarone, quinidine, etc.);
- Drugs that may cause ventricular spasms (e.g. intravenous administration of dantrolene and verapamil);
- Drugs that may increase the risk of hypotension [e.g. CYP3A4 inhibitors (clarithromycin), etc.]
- Patients in a state of chronic inflammation requiring chronic anti-inflammatory treatment;
- Those who have participated in other interventional clinical studies within 6 months of screening;
- Those who have been diagnosed as having malignant tumors within 5 years of screening;
- Those who showed clinically significant abnormal results in electrocardiogram and laboratory tests at screening;
- Those who are pregnant or lactating, or have been confirmed as being pregnant through the Urine HCG test;
- Those who have been judged to be inappropriate to participate in the clinical study by the principal investigator or subinvestigator.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul, 08308
Eung-Ju Kim, Ph.D, 820226263022, withnoel@empas.com
Eung-Ju Kim, Ph.D
About this study
Official title: A 12 Weeks, Multi-center, Randomized, Open Label, Active Control, Phase IV Clinical Trial to Compare Evaluated Improvement of Edema Index, Safety and Efficacy of Amlodipine Versus S Amlodipine in Patients With Essential Hypertension
As a third-generation dihydropyridine calcium channel blocker (CCB), Amlodipine is mainly used in a single therapy or combined therapy for hypertension or angina.
Edema, one of the most common side effects of dihydropyridine CCB formulations, may lead to drug control or discontinuation of drugs.
This clinical study intends to assess the safety and efficacy of S-amlodipine, which is assessed to be superior to Amlodipine in the aspects of antihypertensive effect and side effects, in edema of patients with essential hypertension.
Read the detailed description
- Clinical Study Design
- In this clinical study, Part 1 is conducted as a preliminary study on 10 subjects at a single center, and based on the results of Part 1, the sponsor and the principal investigator determine whether to proceed with Part 2. With Part 2 as the multicenter main study conducted on the remaining 70 subjects, 80 subjects in total have been planned for Part 1 and Part 2.
- Interim analysis
- The interim analysis is conducted when the study on 10 subjects at a Part 1 single center has been completed; the analysis is made on all endpoints planned for this clinical study.
- Clinical study methods - During screening, subjects who have voluntarily signed the Informed Consent Form are tested for eligibility to this clinical study.
After a wash-out period of at least two weeks, subjects who satisfy the inclusion/exclusion criteria are randomly assigned to two groups (S-amlodipine group, Amlodipine group). Thereafter, the subjects are enrolled and orally administered with the investigational product once a day for 12 weeks, during which they receive a total of five visits for tests conducted for assessment of efficacy and safety.
(In case of confirmed eligibility without administration of contraindications, the wash-out period may be omitted and Visits 1 and 2 may be paid on the same day)
- Conditions
- Essential Hypertension
- Being tested
- S-amlodipine 2.5mg, Amlodipine 5mg
- Keywords
- Essential Hypertension, Amlodipine, S-Amlodipine, Hypertension, Blood Pressure, Edema
- Medical subject headings
- Essential Hypertension, Hypertension, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-amlodipine 2.5mgDrug
Also called Levotension Tab.
Oral administration, 1 tablet per day
Amlodipine 5mgDrug
Also called Norvasc Tab.
Oral administration, 1 tablet per day
| Study group | Role | What they receive |
|---|---|---|
| S-amlodipine treatment group | Patients with essential hypertension, who satisfies all criteria listed in eligibility section are randomly assigned, after a wash-out period of at least two weeks. Receives: Drug: S-amlodipine 2.5mg | |
| Amlodipine treatment group | Patients with essential hypertension, who satisfies all criteria listed in eligibility section are randomly assigned, after a wash-out period of at least two weeks. Receives: Drug: Amlodipine 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The variance in edema index [Extracellular water (ECW) / total body water (TBW)] using Inbody measurement between groups at week 12, compared to the baseline.
Descriptive statistics (number of observation subjects, mean, standard deviation, median, minimum, maximum) are summarized by treatment group. Depending on whether there is a difference in the variance between treatment groups (S-amlodipine group, Amlodipine group) that satisfies the normality assumption, analysis is made using either two sample t-test or Wilcoxon's rank sum test.
Measured: Edema indexs (ECW/TBW) are measured at week 4, 8, 12 of treatment.
Secondary outcomes (4)
The variance in edema index between groups at weeks 4 and 8, compared to the baseline
Descriptive statistics (number of observation subjects, mean, standard deviation, median, minimum, maximum) are summarized by treatment group. Depending on whether there is a difference in the variance between treatment groups (S-amlodipine group, Amlodipine group) that satisfies the normality assumption, analysis is made using either two sample t-test or Wilcoxon's rank sum test.
Measured: Edema indexs (ECW/TBW) are measured at week 4, 8, 12 of treatment.
The variance in ankle size (mean size of both ankles using a medical tape measure) between groups at weeks 4, 8, and 12, compared to the baseline.
Mean size of both anckles are tape-measured using medical tape.
Measured: Ankel sizes are measured in at week 4, 8, and 12 of treatment.
The variance in edema index (extracellular moisture per site/water per site) by site (body, right arm, left arm, trunk, right leg, left leg) between groups at weeks 4, 8, and 12, compared to the baseline.
Descriptive statistics (number of observation subjects, mean, standard deviation, median, minimum, maximum) are summarized by site(body, right arm, left arm, trunk, right leg, left leg) and treatment group. Depending on whether there is a difference in the variance between treatment groups (S-amlodipine group, Amlodipine group) that satisfies the normality assumption, analysis is made using either two sample t-test or Wilcoxon's rank sum test.
Measured: Edema indexs (ECW/TBW) by site (body, right arm, left arm, trunk, right leg, left leg) are measured at the week 4, 8, and 12 of treatment.
The variance in blood pressure between groups at weeks 4, 8, and 12, compared to the baseline.
Blood pressure is measured at five-minute intervals after a five-minute rest while seated; three measurements are made for one arm and the SBP and DBP values at each measurement are collected and calculated to derive the mean value.
Measured: Blood pressure are measured at week 4, 8, and 12 of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start28 Oct 2020
- Primary completion23 May 2022 (estimated)
- Study completion23 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Essential 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Korea University Guro Hospital, Dt&Sanomedics
- Responsible party
- Sponsor
- Investigators
- Eung Ju Kim, PhD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554303
- Sponsor's protocol ID
- AG-C1908
- Status last verified
- Sep 2020
- First submitted
- 14 Sep 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pathak L, Hiremath, Kerkar PG, Manade VG. Multicentric, clinical trial of S-Amlodipine 2.5 mg versus Amlodipine 5 mg in the treatment of mild to moderate hypertension--a randomized, double-blind clinical trial. J Assoc Physicians India. 2004 Mar;52:197-202.
PubMed 15636308Pedrinelli R, Dell'Omo G, Melillo E, Mariani M. Amlodipine, enalapril, and dependent leg edema in essential hypertension. Hypertension. 2000 Feb;35(2):621-5. doi: 10.1161/01.hyp.35.2.621.
PubMed 10679507Messerli FH. Vasodilatory edema: a common side effect of antihypertensive therapy. Curr Cardiol Rep. 2002 Nov;4(6):479-82. doi: 10.1007/s11886-002-0110-9.
PubMed 12379167Sener D, Halil M, Yavuz BB, Cankurtaran M, Ariogul S. Anasarca edema with amlodipine treatment. Ann Pharmacother. 2005 Apr;39(4):761-3. doi: 10.1345/aph.1E410. Epub 2005 Feb 22.
PubMed 15728328Brown NJ, Vaughan DE. Angiotensin-converting enzyme inhibitors. Circulation. 1998 Apr 14;97(14):1411-20. doi: 10.1161/01.cir.97.14.1411.
PubMed 9577953Elliott WJ, Meyer PM. Incident diabetes in clinical trials of antihypertensive drugs: a network meta-analysis. Lancet. 2007 Jan 20;369(9557):201-7. doi: 10.1016/S0140-6736(07)60108-1.
PubMed 17240286Makani H, Bangalore S, Romero J, Htyte N, Berrios RS, Makwana H, Messerli FH. Peripheral edema associated with calcium channel blockers: incidence and withdrawal rate--a meta-analysis of randomized trials. J Hypertens. 2011 Jul;29(7):1270-80. doi: 10.1097/HJH.0b013e3283472643.
PubMed 21558959Galappatthy P, Waniganayake YC, Sabeer MI, Wijethunga TJ, Galappatthy GK, Ekanayaka RA. Leg edema with (S)-amlodipine vs conventional amlodipine given in triple therapy for hypertension: a randomized double blind controlled clinical trial. BMC Cardiovasc Disord. 2016 Sep 1;16(1):168. doi: 10.1186/s12872-016-0350-z.
PubMed 27586538Liu F, Qiu M, Zhai SD. Tolerability and effectiveness of (S)-amlodipine compared with racemic amlodipine in hypertension: a systematic review and meta-analysis. Curr Ther Res Clin Exp. 2010 Feb;71(1):1-29. doi: 10.1016/j.curtheres.2010.02.005.
PubMed 24683248Kim SA, Park S, Chung N, Lim DS, Yang JY, Oh BH, Tahk SJ, Ahn TH. Efficacy and safety profiles of a new S(-)-amlodipine nicotinate formulation versus racemic amlodipine besylate in adult Korean patients with mild to moderate hypertension: an 8-week, multicenter, randomized, double-blind, double-dummy, parallel-group, phase III, noninferiority clinical trial. Clin Ther. 2008 May;30(5):845-57. doi: 10.1016/j.clinthera.2008.05.013.
PubMed 18555932Schoeller DA, Alon A, Manekas D, Mixson LA, Lasseter KC, Noonan GP, Bolognese JA, Heymsfield SB, Beals CR, Nunes I. Segmental bioimpedance for measuring amlodipine-induced pedal edema: a placebo-controlled study. Clin Ther. 2012 Mar;34(3):580-92. doi: 10.1016/j.clinthera.2012.01.018. Epub 2012 Mar 3.
PubMed 22385927
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Weeks, Multi-center, Randomized, Open Label, Active Control, Phase IV Clinical Trial to Compare Evaluated Improvement of Edema Index, Safety and Efficacy of Amlodipine Versus S Amlodipine in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT04554303
- Acronym / sponsor ID
- AG-C1908
- Conditions
- Essential Hypertension
- Keywords
- Essential Hypertension, Amlodipine, S-Amlodipine, Hypertension, Blood Pressure, Edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Korea University Guro Hospital, Dt&Sanomedics
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 23 May 2022 (estimated)
- Study completion
- 23 May 2022 (estimated)
- First posted
- 18 Sep 2020 (actual)
- 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.
As a third-generation dihydropyridine calcium channel blocker (CCB), Amlodipine is mainly used in a single therapy or combined therapy for hypertension or angina.
Edema, one of the most common side effects of dihydropyridine CCB formulations, may lead to drug control or discontinuation of drugs.
This clinical study intends to assess the safety and efficacy of S-amlodipine, which is assessed to be superior to Amlodipine in the aspects of antihypertensive effect and side effects, in edema of patients with essential hypertension.
Detailed description
- Clinical Study Design
- In this clinical study, Part 1 is conducted as a preliminary study on 10 subjects at a single center, and based on the results of Part 1, the sponsor and the principal investigator determine whether to proceed with Part 2. With Part 2 as the multicenter main study conducted on the remaining 70 subjects, 80 subjects in total have been planned for Part 1 and Part 2.
- Interim analysis
- The interim analysis is conducted when the study on 10 subjects at a Part 1 single center has been completed; the analysis is made on all endpoints planned for this clinical study.
- Clinical study methods - During screening, subjects who have voluntarily signed the Informed Consent Form are tested for eligibility to this clinical study.
After a wash-out period of at least two weeks, subjects who satisfy the inclusion/exclusion criteria are randomly assigned to two groups (S-amlodipine group, Amlodipine group). Thereafter, the subjects are enrolled and orally administered with the investigational product once a day for 12 weeks, during which they receive a total of five visits for tests conducted for assessment of efficacy and safety.
(In case of confirmed eligibility without administration of contraindications, the wash-out period may be omitted and Visits 1 and 2 may be paid on the same day)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-amlodipine treatment group | – | Drug: S-amlodipine 2.5mgPatients with essential hypertension, who satisfies all criteria listed in eligibility section are randomly assigned, after a wash-out period of at least two weeks. |
| Amlodipine treatment group | – | Drug: Amlodipine 5mgPatients with essential hypertension, who satisfies all criteria listed in eligibility section are randomly assigned, after a wash-out period of at least two weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ordinary patients with essential hypertension who visits the medical institution participating in this study, and volunteers to enroll in this study.
Key inclusion criteria (8 listed)
- Patients with essential hypertension and diagnosed with stage 1-2 hypertension in accordance with the 2019 Korean Society of Hypertension criteria (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg)
- Where a subject and his/her spouse (partner) have agreed to use medically acceptable contraceptives in the following during participation in this clinical study:
- Those who have made voluntary decisions to participate in this clinical study and have consented to the Informed Consent Form in writing;
- Those who are able to understand and follow instructions and participate throughout the entire clinical study
Key exclusion criteria (30 listed)
- Patients with uncontrolled, high-risk hypertension (SBP≥180mm Hg and DBP≥110mm Hg);
- Those who have a history of secondary hypertension and any history of suspected secondary hypertension (aortic congestion, hyperaldosteronism, renal artery stenosis, Cushing's disease, chromaffinoma, polycystic renal disease, etc.);
- Those who fall under one or more of the following items that may cause edema without underlying diseases:
- Those who have cerebrovascular disease, unstable angina, or transient ischemic attack, or those who have had coronary artery bypass graft or coronary angioplasty;
- Patients who may develop edema by concomitant drugs at screening:
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 |
|---|---|---|
| S-amlodipine 2.5mgAlso: Levotension Tab.Oral administration, 1 tablet per day | Drug | S-amlodipine treatment group |
| Amlodipine 5mgAlso: Norvasc Tab.Oral administration, 1 tablet per day | Drug | Amlodipine treatment group |
Primary outcome
The variance in edema index [Extracellular water (ECW) / total body water (TBW)] using Inbody measurement between groups at week 12, compared to the baseline.
Time frame: Edema indexs (ECW/TBW) are measured at week 4, 8, 12 of treatment.
Descriptive statistics (number of observation subjects, mean, standard deviation, median, minimum, maximum) are summarized by treatment group. Depending on whether there is a difference in the variance between treatment groups (S-amlodipine group, Amlodipine group) that satisfies the normality assumption, analysis is made using either two sample t-test or Wilcoxon's rank sum test.
4 secondary outcomes
The variance in edema index between groups at weeks 4 and 8, compared to the baseline
Time frame: Edema indexs (ECW/TBW) are measured at week 4, 8, 12 of treatment.
The variance in ankle size (mean size of both ankles using a medical tape measure) between groups at weeks 4, 8, and 12, compared to the baseline.
Time frame: Ankel sizes are measured in at week 4, 8, and 12 of treatment.
The variance in edema index (extracellular moisture per site/water per site) by site (body, right arm, left arm, trunk, right leg, left leg) between groups at weeks 4, 8, and 12, compared to the baseline.
Time frame: Edema indexs (ECW/TBW) by site (body, right arm, left arm, trunk, right leg, left leg) are measured at the week 4, 8, and 12 of treatment.
The variance in blood pressure between groups at weeks 4, 8, and 12, compared to the baseline.
Time frame: Blood pressure are measured at week 4, 8, and 12 of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Background: PubMed 15636308Pathak L, Hiremath, Kerkar PG, Manade VG. Multicentric, clinical trial of S-Amlodipine 2.5 mg versus Amlodipine 5 mg in the treatment of mild to moderate hypertension--a randomized, double-blind clinical trial. J Assoc Physicians India. 2004 Mar;52:197-202.
- Background: PubMed 10679507Pedrinelli R, Dell'Omo G, Melillo E, Mariani M. Amlodipine, enalapril, and dependent leg edema in essential hypertension. Hypertension. 2000 Feb;35(2):621-5. doi: 10.1161/01.hyp.35.2.621.
- Background: PubMed 12379167Messerli FH. Vasodilatory edema: a common side effect of antihypertensive therapy. Curr Cardiol Rep. 2002 Nov;4(6):479-82. doi: 10.1007/s11886-002-0110-9.
- Background: PubMed 15728328Sener D, Halil M, Yavuz BB, Cankurtaran M, Ariogul S. Anasarca edema with amlodipine treatment. Ann Pharmacother. 2005 Apr;39(4):761-3. doi: 10.1345/aph.1E410. Epub 2005 Feb 22.
- Background: PubMed 9577953Brown NJ, Vaughan DE. Angiotensin-converting enzyme inhibitors. Circulation. 1998 Apr 14;97(14):1411-20. doi: 10.1161/01.cir.97.14.1411.
- Background: PubMed 17240286Elliott WJ, Meyer PM. Incident diabetes in clinical trials of antihypertensive drugs: a network meta-analysis. Lancet. 2007 Jan 20;369(9557):201-7. doi: 10.1016/S0140-6736(07)60108-1.
- Background: PubMed 21558959Makani H, Bangalore S, Romero J, Htyte N, Berrios RS, Makwana H, Messerli FH. Peripheral edema associated with calcium channel blockers: incidence and withdrawal rate--a meta-analysis of randomized trials. J Hypertens. 2011 Jul;29(7):1270-80. doi: 10.1097/HJH.0b013e3283472643.
- Background: PubMed 27586538Galappatthy P, Waniganayake YC, Sabeer MI, Wijethunga TJ, Galappatthy GK, Ekanayaka RA. Leg edema with (S)-amlodipine vs conventional amlodipine given in triple therapy for hypertension: a randomized double blind controlled clinical trial. BMC Cardiovasc Disord. 2016 Sep 1;16(1):168. doi: 10.1186/s12872-016-0350-z.
- Background: PubMed 24683248Liu F, Qiu M, Zhai SD. Tolerability and effectiveness of (S)-amlodipine compared with racemic amlodipine in hypertension: a systematic review and meta-analysis. Curr Ther Res Clin Exp. 2010 Feb;71(1):1-29. doi: 10.1016/j.curtheres.2010.02.005.
- Background: PubMed 18555932Kim SA, Park S, Chung N, Lim DS, Yang JY, Oh BH, Tahk SJ, Ahn TH. Efficacy and safety profiles of a new S(-)-amlodipine nicotinate formulation versus racemic amlodipine besylate in adult Korean patients with mild to moderate hypertension: an 8-week, multicenter, randomized, double-blind, double-dummy, parallel-group, phase III, noninferiority clinical trial. Clin Ther. 2008 May;30(5):845-57. doi: 10.1016/j.clinthera.2008.05.013.
- Background: PubMed 22385927Schoeller DA, Alon A, Manekas D, Mixson LA, Lasseter KC, Noonan GP, Bolognese JA, Heymsfield SB, Beals CR, Nunes I. Segmental bioimpedance for measuring amlodipine-induced pedal edema: a placebo-controlled study. Clin Ther. 2012 Mar;34(3):580-92. doi: 10.1016/j.clinthera.2012.01.018. Epub 2012 Mar 3.
- Individual participant dataSharing planned: No
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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.
Eung Ju Kim, PhD 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?
An observational study of Essential Hypertension, run by Ahn-Gook Pharmaceuticals Co.,Ltd 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 8 inclusion and 30 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 12 Nov 2020. 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 Jin Ho Kim, Master's (8207042335338, jhkim@dtnsm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The variance in edema index [Extracellular water (ECW) / total body water (TBW)] using Inbody measurement between groups at week 12, compared to the baseline. (time frame: Edema indexs (ECW/TBW) are measured at week 4, 8, 12 of treatment.). 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 NCT04554303, which also lists 11 linked publications.
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 Nov 2020.