Efficacy and Safety of Fimasartan Alone or Combined With HCTZ in Mexican Patients With Essential Hypertension

NCT02466490 | Completed Phase 3

• 1 other identifier: FIMA-MEX-12-01
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 13

Brief Summary

Fimasartan (FMS) is an AT1 receptor antagonist indicated for once a day administration, currently approved for the treatment of essential hypertension in Corea and Mexico. As the safety and efficacy of FMS was initially demonstrated in Korea only, it was necessary to address the potential for ethnic factors to have an effect on the drug´s efficacy and safety in the Mexican population. To address this need, a cohort of 272 Mexican subjects with grades 1-2 essential hypertension were sequentially treated on a treat to target basis (target: sitting Diastolic Blood Pressure (sDBP) \<90 mmHg) with 60 mg FMS once a day (8 weeks), either 120 mg FMS or 60 mg FMS+12.5 mg HCTZ once a day (randomized 4 week treatment period) and 120 mg FMS once a day (during 12 weeks) for a total treatment period of 24 weeks.

Conditions

Hypertension, Essential

Outcome Measures

Primary Outcomes (1)

• Blood Pressure Change From Baseline

  Treatment Week 8 mean sDBP and sitting Systolic Blood Pressure (SBP) changes from baseline (all study subjects treated with 60 mg FMS once a day)

  Baseline to Treatment Week 8

Secondary Outcomes (6)

• Blood Pressure Change from Week 8

  Treatment Week 8 to Treatment Week 12

• Week 8 Treatment Response Rate

  Baseline to Treatment Week 8

• Week 12 Treatment Response Rate

  Treatment Weeks 8 to 12

• Blood Pressure Change from Week 12

  Treatment Weeks 12 to 24

• Week 24 Treatment Response Rate

  Treatment Weeks 12 to 24

Other Outcomes (4)

• Pro-inflammatory marker changes from baseline

  Baseline to treatment week 8

• Treatment Week 8 ABPM mean 24-hour BP changes from baseline

  Baseline to treatment week 8

• Treatment Week 8 ABPM mean Daytime BP changes from baseline

  Baseline to treatment week 8

Study Arms (4)

Fimasartan 60 mg Tablets

EXPERIMENTAL

FMS 60 mg tablets once a day during the initial 8 treatment weeks of the study

Drug: Fimasartan

Fimasartan 120 mg Tablets

ACTIVE COMPARATOR

FMS 120 mg tablets once a day during 4 weeks (treatment weeks 8 to 12)

Drug: Fimasartan

Fimasartan; Hydrochlorothiazide 60/12.5

ACTIVE COMPARATOR

FMS 60 mg + HCTZ 12.5 mg tablets (fixed dose combination) once a day during 4 weeks (treatment weeks 8 to 12)

Drug: Fimasartan; Hydrochlorothiazide

Fimasartan; Hydrochlorothiazide 120/12.5

EXPERIMENTAL

FMS 120 mg + HCTZ 12.5 mg tablets (fixed dose combination) once a day during 12 weeks (treatment weeks 12 to 24)

Drug: Fimasartan; Hydrochlorothiazide

Interventions

Fimasartan DRUG

Fimasartan tablets

Also known as: Arakhor, Kanarb

Fimasartan 120 mg Tablets; Fimasartan 60 mg Tablets

Fimasartan; Hydrochlorothiazide DRUG

Fimasartan plus hydrochlorothiazide fixed dose combination tablets

Also known as: Diarakhor, Kanarb plus

Fimasartan; Hydrochlorothiazide 120/12.5; Fimasartan; Hydrochlorothiazide 60/12.5

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand the study subject information and to voluntarily grant their informed consent.
• Men or women, 18 to 70 years old.
• With grade 1 or 2 essential arterial hypertension based on a sitting diastolic blood pressure (DBP) ≥90 mmHg and ≤109 mmHg (MEXICAN OFFICIAL NORM 030-SSA).
• Trustworthiness and willingness to attend all the study follow-up visits , according to the investigator's judgment.
• Patients already on antihypertensive therapy, not adequately controlled and that, according to the investigator's judgment, could be safely submitted to a two-week washout period.

You may not qualify if:

• Severe hypertension (Grade 3), with SBP≥180 mmHg and/or DBP≥110 mmHg, according to OFFICIAL MEXICAN NORM NOM 030-SSA criteria.
• Secondary hypertension.
• Impossibility to safely undergo a two week washout period from previous treatment prior to assignment to the study treatment, if applicable and according to the principal investigator´s judgment.
• Systemic diseases such as renal dysfunction (creatinine ≥1.5 time above the upper limit of the reference range), gastrointestinal disorders, hematological disorders or liver dysfunction (AST y/o ALT ≥1.5 times the upper limit of the reference range), capable to affect the absorption, distribution, metabolism and excretion of the study drug.
• Non-controlled diabetes mellitus (HbA1c\>9%)
• Morbid obesity (BMI≥40 kg/m2)
• Myocardial infarction or severe coronary artery disease or clinically significant congestive heart failure, within the six months prior to the screening visit.
• Auto-immune or connective tissue disease.
• Evidence in the medical record of serious infectious diseases such as hepatitis type B or C or a positive HIV test at screening.
• Clinically significant laboratory test abnormalities, according to the investigator's judgment.
• Concomitant treatment which might affect blood pressure values.
• Known allergies or contraindication to the use of angiotensin II receptor antagonists.
• Pregnancy, breastfeeding or in the case of women with childbearing potential, the rejection to use an effective contraceptive method, according to the investigator's judgment.
• History of alcohol or addictive substance abuse.
• Subjects participating in other clinical studies or who have participated in other study within the 6 months prior to screening.

Sponsors & Collaborators

• Stendhal Americas, S.A.: lead

Study Sites (13)

Hospital de Jesús IAP

México, D.f., 06090, Mexico

Location

Hospital General de Ticomán

México, D.f., 07330, Mexico

Location

Centro Médico Exel

Tijuana, Estado de Baja California, 22010, Mexico

Location

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44100, Mexico

Location

Unidad de Investigación Clínica Cardiometabólica de Occidente

Guadalajara, Jalisco, 44140, Mexico

Location

Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location

Icle S.C.

Guadalajara, Jalisco, 44600, Mexico

Location

Núcleo Médico La Paz

Guadalajara, Jalisco, 44860, Mexico

Location

Hospital Dr. Ángel Leaño

Zapopan, Jalisco, 45157, Mexico

Location

Instituto Jalisciense de Investigación en Diabetes y Obesidad S. C.

Guadalajara, Jalsico, 44600, Mexico

Location

Cardiolink Clintrials

Monterrey, Nuevo León, 64060, Mexico

Location

Centro de Estudios Clínicos y Especialidades Médicas

Monterrey, Nuevo León, 64620, Mexico

Location

Hospital Dr. Ignacio Morones Prieto

San Luis Potosí City, San Luis Potosí, 78240, Mexico

Location

Related Publications (6)

• Lee H, Yang HM, Lee HY, Kim JJ, Choi DJ, Seung KB, Jeon ES, Ha JW, Rim SJ, Park JB, Shin JH, Oh BH. Efficacy and tolerability of once-daily oral fimasartan 20 to 240 mg/d in Korean Patients with hypertension: findings from Two Phase II, randomized, double-blind, placebo-controlled studies. Clin Ther. 2012 Jun;34(6):1273-89. doi: 10.1016/j.clinthera.2012.04.021. Epub 2012 May 17.

  PMID: 22608107 RESULT

• Lee SE, Kim YJ, Lee HY, Yang HM, Park CG, Kim JJ, Kim SK, Rhee MY, Oh BH; Investigators. Efficacy and tolerability of fimasartan, a new angiotensin receptor blocker, compared with losartan (50/100 mg): a 12-week, phase III, multicenter, prospective, randomized, double-blind, parallel-group, dose escalation clinical trial with an optional 12-week extension phase in adult Korean patients with mild-to-moderate hypertension. Clin Ther. 2012 Mar;34(3):552-568, 568.e1-9. doi: 10.1016/j.clinthera.2012.01.024. Epub 2012 Mar 3.

  PMID: 22381711 RESULT

• Lee H, Kim KS, Chae SC, Jeong MH, Kim DS, Oh BH. Ambulatory blood pressure response to once-daily fimasartan: an 8-week, multicenter, randomized, double-blind, active-comparator, parallel-group study in Korean patients with mild to moderate essential hypertension. Clin Ther. 2013 Sep;35(9):1337-49. doi: 10.1016/j.clinthera.2013.06.021. Epub 2013 Aug 7.

  PMID: 23932463 RESULT

• Park JB, Sung KC, Kang SM, Cho EJ. Safety and efficacy of fimasartan in patients with arterial hypertension (Safe-KanArb study): an open-label observational study. Am J Cardiovasc Drugs. 2013 Feb;13(1):47-56. doi: 10.1007/s40256-013-0004-9.

  PMID: 23344912 RESULT

• Chi YH, Lee H, Paik SH, Lee JH, Yoo BW, Kim JH, Tan HK, Kim SL. Safety, tolerability, pharmacokinetics, and pharmacodynamics of fimasartan following single and repeated oral administration in the fasted and fed states in healthy subjects. Am J Cardiovasc Drugs. 2011 Oct 1;11(5):335-46. doi: 10.2165/11593840-000000000-00000.

  PMID: 21910510 RESULT

• Madamanchi NR, Vendrov A, Runge MS. Oxidative stress and vascular disease. Arterioscler Thromb Vasc Biol. 2005 Jan;25(1):29-38. doi: 10.1161/01.ATV.0000150649.39934.13. Epub 2004 Nov 11.

  PMID: 15539615 RESULT

MeSH Terms

Conditions

Essential Hypertension

Interventions

fimasartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ignacio Conde-Carmona, M.D.

  Específicos Stendhal S.A. de C.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 9, 2015
• Study Start: April 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 9, 2015

Record last verified: 2015-06

Locations

ME (13)