Status:
UNKNOWN
Fimasartan Plus Amlodipine on Hemodynamic Parameters and Arterial Stiffness in Patients With Hypertension
Lead Sponsor:
Centro Universitario de Ciencias de la Salud, Mexico
Conditions:
Arterial Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
Detailed Description
A prospective, open clinical trial of a cohort of adult patients of both sexes with recent 2-3 years high blood pressure. Intervention: Fimasartan 60 mg + amlodipine besylate 5 mg once daily Purpose...
Eligibility Criteria
Inclusion
- 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.
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Exclusion
- 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
- 13\. Clinically significant rhythm disorders 14. Clinically significant abnormal laboratory parameters in the investigator's judgment.
- 15\. Concurrent treatment that may affect blood pressure and which can not be withdrawn in the opinion of the investigator. 16.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.
- 19\. 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.
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Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2018
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03294070
Start Date
September 1 2017
End Date
August 1 2018
Last Update
September 26 2017
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