Fimasartan Plus Amlodipine on Hemodynamic Parameters and Arterial Stiffness in Patients With Hypertension

NCT03294070 | Unknown Phase 4

• 1 other identifier: INTEC-1
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

24-week open clinical trial to assess tolerability and effect on pressure, hemodynamic parameters and arterial rigidity of the combined treatment based on Fimasartan 60 mg and amlodipine besylate 5 mg given once daily in patients with arterial hypertension in stages 2-3

Conditions

Arterial Hypertension

Keywords

hemodynamic parameters; arterial stiffness

Outcome Measures

Primary Outcomes (1)

• Reduction of pulse wave velocity

  The administration of combined dose-based treatment of 60 mg of fimasartan plus 5 mg of amlodipine besylate QD administered according to the treatment schedule for 24 weeks reduces VOPcf in Mexican Patients with Essential Arterial Hypertension grades 2 and 3

  24 week

Secondary Outcomes (3)

• Central Aortic Pressure

  24 week

• Central Pulse Pressure

  24 week

• Rising Index

  24 week

Study Arms (1)

Fimasartan 60 mg + amlodipine besylate 5 mg

EXPERIMENTAL

Fimasartan 60 mg + amlodipine besylate 5 mg. In subjects with a DBP equal to or greater than 90 mmHg and / or SBP equal to or greater than 140 mmHg at week 8, the investigator will have the option, according to his clinical criteria, to add 12.5 mg of HCTZ QD (in these cases, the subject will receive one 60 mg Fimasartan tablet plus 12.5 mg HCTZ plus one 5 mg amlodipine besylate tablet.

Combination Product: Fimasartan plus amlodipine besylate

Interventions

Fimasartan plus amlodipine besylate COMBINATION_PRODUCT

Fimasartan 60 mg plus amlodipine besylate 5 mg or Fimasartan plus 12.5 mg HCTZ plus one 5 mg amlodipine besylate

Fimasartan 60 mg + amlodipine besylate 5 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject capable of understanding and signing voluntarily informed consent.
• Men and women aged 18-65 years.
• To have essential hypertension grade 2 or 3 according to the figures of diastolic blood pressure and / or systolic in office according to NOM-030 SSA.
• Reliable and willing to attend all study visits for the duration of the study and the follow-up according to the researcher's criteria.
• Patients on antihypertensive treatment and who in the judgment of the investigator and taking care of the health and safety of the patient can undergo 2 weeks of previous washing to the visit of day 0.

You may not qualify if:

• Secondary arterial hypertension.
• Patients currently under treatment that at the discretion of the investigator can not be submitted to wash period.
• Severe renal insufficiency (glomerular filtration rate \<30 mL / min / 1.73 m2)
• Moderate to severe hepatic impairment (Child-Pugh B or C classification).
• Hypersensitivity to any of the components of the research products
• Hepatobiliary obstruction
• Myocardial infarction or severe coronary artery disease (including angina pectoris unstable) or clinically significant congestive heart failure within 6 months prior to visit to week-1 (selection).
• Left ventricular ejection fraction ≤40%
• Resting heart rate ≥90 lpm
• Thyroid disorder (treated subjects may be involved who are euthyroid)
• Clinically significant mitral or aortic valve disease (Grade ≥ 2) Hypertrophic obstructive cardiomyopathy
• \. Clinically significant rhythm disorders 14. Clinically significant abnormal laboratory parameters in the investigator's judgment.
• \. Concurrent treatment that may affect blood pressure and which can not be withdrawn in the opinion of the investigator. 16. A history of galactose intolerance or glucose-galactose malabsorption. 17. Pregnancy, breastfeeding. 18. Women capable of procreation DO NOT adopt an effective contraceptive method according to criterion of the investigator.
• \. Patients participating in or participating in other research protocols within 3 months prior to week 1 visit (selection). 20. Another reason not previously specified but in the opinion of the investigator may contraindicate their participation in the study.

Sponsors & Collaborators

• Centro Universitario de Ciencias de la Salud, Mexico: lead

MeSH Terms

Conditions

Hypertension

Interventions

fimasartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Ernesto G Cardona -Muñoz, PhD

CONTACT

+52 3336173499; cameg1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ernesto German Cardona Muñoz

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 26, 2017
• Study Start: September 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 26, 2017

Record last verified: 2017-09