Multicentre, multinational, prospective randomised, open-label, 3 sequence crossover phase III b clinical trial with blinded endpoint assessment (PROBE-design)
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.
| Condition | Cerebral Small Vessel Diseases |
|---|---|
| Treatment | losartan, Amlodipine, Atenolol |
| Clinical Study Identifier | NCT03082014 |
| Sponsor | Ludwig-Maximilians - University of Munich |
| Last Modified on | 2 February 2023 |
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