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EffecTs of Amlodipine and Other Blood PREssure Lowering Agents on Microvascular FuncTion in Small Vessel Diseases
Multicentre, multinational, prospective randomised, open-label, 3 sequence crossover phase III b clinical trial with blinded endpoint assessment (PROBE-design) * in 75 patients with sporadic small vessel diseases (SVDs) and * in 30 patients with cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL)
TREAT-SVDs will be carried out as a multicentre open label trial at five trial sites across 3 European countries: Germany, the Netherlands, and the United Kingdom. Patients meeting eligibility criteria will be randomly allocated to one of three sequences of antihypertensive treatment which are given as open-label oral medications in standard dose in the following order Arm A: Amlodipine \> Losartan \> Atenolol Arm B: Atenolol \> Amlodipine \> Losartan Arm C: Losartan \> Atenolol \> Amlodipine. The study starts with a two week run-in phase. During these first two weeks, patients are not allowed to take antihypertensive drugs except for the rescue medication. After the run-in period,every patient will take subsequently three different antihypertensive drugs (each drug from a separate drug class) according to the randomly assigned arm. Each study drug will be administered for four weeks. Patients will be monitored telemetrically with a dedicated BP device during the whole trial period of 14 weeks.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Insitute for Stroke and Dementia Research
Munich, Germany
Maastricht University Medical Center
Maastricht, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Nuffield Department of Clinical Neurosciences
Oxford, England, United Kingdom
Centre for Clinical Brain Sciences
Edinburgh, Scotland, United Kingdom
Start Date
February 22, 2018
Primary Completion Date
July 28, 2022
Completion Date
July 28, 2022
Last Updated
March 9, 2023
101
ACTUAL participants
Amlodipine
DRUG
Losartan
DRUG
Atenolol
DRUG
Lead Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
NCT04753970
NCT06164262
Data Source & Attribution
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