2023-504812-13-00进行中（未招募）Phase III and phase IV (Integrated)
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
KRKA tovarna zdravil d.d. Novo mesto, KRKA tovarna zdravil d.d. Novo mesto, KRKA tovarna zdravil d.d. Novo mesto12 个研究点 分布在 3 个国家目标入组 110 人开始时间: 2024年1月16日最近更新:
试验速览
- 阶段
- Phase III and phase IV (Integrated)
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 12
- 主要终点
- Mean absolute change of 24-hour SBP after 16 weeks of treatment (from baseline to Visit 7) with TIMP.
研究概览
简要总结
To assess efficacy of treatment with single-pill combination (SPC) of telmisartan/amlodipine (T/A) and SPC of telmisartan/amlodipine/hydrochlorothiazide (T/A/HCTZ) on 24-hour blood pressure (BP) reduction after 16 weeks of treatment in patients with Grade 1, Grade 2 or Grade 3 arterial hypertension.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosed Grade 1, Grade 2 or Grade 3 Arterial Hypertension at Visit 1 AND Visit
- •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.
排除标准
- •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.
结局指标
主要结局
Mean absolute change of 24-hour SBP after 16 weeks of treatment (from baseline to Visit 7) with TIMP.
Mean absolute change of 24-hour SBP after 16 weeks of treatment (from baseline to Visit 7) with TIMP.
次要结局
- Mean change in average real variability of 24-hour SBP (ARVs) and mean change in average real variability of 24-hour DBP (ARVd) after 16 weeks of treatment (from baseline to Visit 7) with TIMP.
- Mean absolute change of 24-hour DBP after 16 weeks of treatment (from baseline to Visit 7) with TIMP.
- Mean absolute and relative changes of office SBP and DBP after 4, 8, 12 and 16 weeks of treatment (from baseline to Visit 3, Visit 4, Visit 5 and Visit 7, respectively) with TIMP.
- Mean absolute change of the calculated central SBP (cSBP) and calculated central DBP (cDBP) after 16 weeks of treatment (from baseline to Visit 7) with TIMP.
- Mean SI after 16 weeks of treatment (from baseline to Visit 7) with TIMP.
- Mean absolute changes of 24-hour SBP, separately in groups of dipping, extreme dipping and non-dipping patients after 16 weeks of treatment (from baseline to Visit 7) with TIMP.
- Mean absolute change of pulse wave velocity (PWV) after 16 weeks of treatment (from baseline to Visit 7) with TIMP.
研究者
Breda Barbič-Žagar
Scientific
KRKA tovarna zdravil d.d. Novo mesto
研究点 (12)
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