Comparing Safety and Efficacy of Amlodipine Verses S Amlodipine in Patients With Essential Hypertension

NCT04554303 | Unknown FDA Drug

• 1 other identifier: AG-C1908
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Essential Hypertension

Keywords

Essential Hypertension; Amlodipine; S-Amlodipine; Hypertension; Blood Pressure; Edema

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

  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.

  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 are measured at week 4, 8, and 12 of treatment.

Study Arms (2)

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.

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.

Drug: Amlodipine 5mg

Interventions

S-amlodipine 2.5mg DRUG

Oral administration, 1 tablet per day

Also known as: Levotension Tab.

S-amlodipine treatment group

Amlodipine 5mg DRUG

Oral administration, 1 tablet per day

Also known as: Norvasc Tab.

Amlodipine treatment group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ordinary patients with essential hypertension who visits the medical institution participating in this study, and volunteers to enroll in this study.

You may qualify if:

• 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

You may not qualify if:

• 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);
• 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.);

Sponsors & Collaborators

• Ahn-Gook Pharmaceuticals Co.,Ltd: lead
• Korea University Guro Hospital: collaborator
• Dt&Sanomedics: collaborator

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

Related Publications (11)

• 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.

  PMID: 15636308 BACKGROUND

• Pedrinelli 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.

  PMID: 10679507 BACKGROUND

• Messerli 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.

  PMID: 12379167 BACKGROUND

• Sener 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.

  PMID: 15728328 BACKGROUND

• Brown NJ, Vaughan DE. Angiotensin-converting enzyme inhibitors. Circulation. 1998 Apr 14;97(14):1411-20. doi: 10.1161/01.cir.97.14.1411.

  PMID: 9577953 BACKGROUND

• Elliott 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.

  PMID: 17240286 BACKGROUND

• Makani 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.

  PMID: 21558959 BACKGROUND

• Galappatthy 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.

  PMID: 27586538 BACKGROUND

• Liu 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.

  PMID: 24683248 BACKGROUND

• Kim 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.

  PMID: 18555932 BACKGROUND

• Schoeller 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.

  PMID: 22385927 BACKGROUND

MeSH Terms

Conditions

Essential Hypertension; Hypertension; Edema

Interventions

levamlodipine; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eung Ju Kim, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Ho Kim, Master's

CONTACT

8207042335338; jhkim@dtnsm.com

Sun Kyung Lee, Bachelor's

CONTACT

8207041521475; sklee@dtnsm.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 18, 2020
• Study Start: October 28, 2020
• Primary Completion: May 23, 2022
• Study Completion: May 23, 2022
• Last Updated: November 12, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)