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

Phase 1

Recruiting

• Conditions: Arterial hypertension; MedDRA version: 21.1Level: LLTClassification code: 10081425Term: Arterial hypertension Class: 10047065; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-504812-13-00
• Lead Sponsor: KRKA tovarna zdravil d.d. Novo mesto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-22
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: To assess efficacy of treatment with SPC of T/A and SPC of T/A/HCTZ on office BP control and on 24-hour BP variability after 16 weeks of treatment in patients with Grade 1, Grade 2 or Grade 3 arterial hypertension.;Primary end point(s): Mean absolute change of 24-hour SBP after 16 weeks of treatment (from baseline to Visit 7) with TIMP.