NCT03626259

Losartan/Amlodipine on Hemodynamics Parameters and Arterial Stiffness in Arterial Hypertension

Status unknown Phase 4 Last updated 17 August 2018

What this trial tests

Phase 4 trial testing Losartan and Amlodipine in Hypertension in 28 participants. Status unknown.

Timeline

6 August 2018

Primary endpoint
15 January 2019

14 June 2019

Quick facts

Lead sponsor	Centro Universitario de Ciencias de la Salud, Mexico
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	28
Start date	6 August 2018
Primary completion	15 January 2019
Estimated completion	14 June 2019
Sites	1 location across Mexico

Drugs / interventions tested

• Losartan and Amlodipine — full drug profile →
• Losartan (losartan) — full drug profile →

Conditions studied

• Hypertension — all drugs for Hypertension →

Sponsor

Centro Universitario de Ciencias de la Salud, Mexico — full company profile →

Who can join

Adults 40 to 65, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Systemic Arterial Hypertension (SAH) is a disease with a high prevalence in Mexico and worldwide. SAH is associated with an increase in cardiovascular morbidity and mortality, causing cardiovascular disease (CVD), heart failure (HF), as well as chronic kidney disease (CKD). Several of the physiopathological mechanisms observed are: the increase in cardiac output, central aortic pressure (CAP), pulse wave velocity (PWV) and peripheral vascular resistance (PVR), which leads to the generation of damage to the target organ. The identification not only of the peripheral arterial pressure, but also of these hemodynamic parameters and arterial stiffness would allow a better cardiovascular characterization of the patients. However, the measurements of hemodynamic parameters and arterial stiffness can vary during the 24 hours from individual to individual by all known mechanisms involved in the regulation of blood pressure such as cortisol, central nervous system, the peripheral nervous system, along with the renin angiotensin and aldosterone system, which are usually only measured in a single moment. Generally, the choice of drug in a patient with SAH is based only on the values of peripheral blood pressure at the time of the measurement. The use of oscillometric equipment such as the Mobil-O-Graph 24 allows to the investigators to know the hemodynamic and arterial stiffness behavior during 24 hours; therefore, this could favor the choice of the most appropriate antihypertensive drug, dose and administration time. The use of angiotensin II receptor antagonists (ARA II) At1 blockers such as losartan and calcium channel blockers (CCB) for instance amlodipine have shown a reduction in CAP and peripheral blood pressure respectively in patients with SAH. The most prescribed drugs in health units worldwide are enalapril, amlodipine, losartan and atenolol, of which the most used combination is losartan with amlodipine. There are no studies to date that allow investigators to identify the effect of the administration of losartan / amlodipine in a fixed combination form on the hemodynamic parameters and arterial stiffness of patients with SAH. Therefore, the objective of the present study is to evaluate the effect of this fixed combination versus losartan on hemodynamic and arterial stiffness parameters based on the behavior of these for 24 hours.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.