Effects of single-pill combination of telmisartan/amlodipine and telmisartan/amlodipine/hydrochlorothiazide on 24-hour blood pressure (BP) reduction, 24-h BP variability and office BP control in patients with arterial hypertension – SATELLITE - KCT02/2023-SATELLITE

KRKA tovarna zdravil d.d. Novo mesto0 个研究点目标入组 191 人开始时间: 2023年9月22日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Patients with diagnosed Grade 1, Grade 2 or Grade 3 Arterial Hypertension at Visit 1 AND Visit 2., Average 24-hour SBP =130 mmHg AND/OR average 24-hour DBP =80 mmHg, obtained by the ambulatory blood pressure monitoring (ABPM) device at the study baseline., Patients who are treatment-naïve OR uncontrolled on: existing antihypertensive monotherapy or dual combinational therapy (except those on telmisartan and amlodipine therapy)., Female or male patients, aged =18 years., Patients with ability to adhere to the trial protocol according to the investigator’s judgement, Patients who have been provided with information about the trial and have voluntarily signed the informed consent., Patients who have signed the consent for collection, analysis and processing of personal data, that will be collected during this clinical trial for the purpose of statistical analysis and final report of this clinical trial.

•Previous or current antihypertensive therapy with telmisartan and amlodipine taken concomitantly or as single-pill combination., Any of the following laboratory or ECG findings: significant anaemia with haemoglobin less than 100 g/L, abnormal values of serum potassium (i.e. hypo- and hyperkalaemia; with reference to the normal laboratory values) that are clinically significant according to the investigator’s judgement, hypercalcaemia (with reference to the normal laboratory values) that is clinically significant according to the investigator’s judgement, atrioventricular (A-V) block grade 2 or 3, ECG signs of acute ischemia., Renal impairment – GFR <45 ml/min/1.73 m2 (e.g. bilateral renal artery stenosis, renal artery stenosis in a solitary kidney or post-renal transplant patients, dialysis patients, anuria)., Concomitant therapy with: pressor amines, lithium, digoxin, aliskiren-containing products, drugs that can provoke hyperkalaemia: potassium supplements, or potassium-containing salt substitutes, drugs that may reduce the antihypertensive effect: systemic corticosteroids., Non-compliance with 24-hour BP measurement quality criteria.

发起方

KRKA tovarna zdravil d.d. Novo mesto