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Effects of Amlodipine and Other Blood Pressure Lowering Agents on Microvascular Function — TREAT-SVDs  

Cerebral Small Vessel Diseases Clinical Trial

Official title:
EffecTs of Amlodipine and Other Blood PREssure Lowering Agents on Microvascular FuncTion in Small Vessel Diseases

Clinical Trial Summary

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)

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03082014
Study type Interventional
Source Ludwig-Maximilians - University of Munich
Contact
Status Terminated
Phase Phase 3
Start date February 22, 2018
Completion date July 28, 2022
View Details
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