NCT03082014

Effects of Amlodipine and Other Blood Pressure Lowering Agents on Microvascular Function

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Cerebral Small Vessel Diseases

Interventions

Type	Name	Description
DRUG	Amlodipine	blood pressure lowering agent - dihydropyridine Ca2+-channel blocker
DRUG	Losartan	blood pressure lowering agent - angiotensin-receptor blockers
DRUG	Atenolol	blood pressure lowering agent - beta-blocker

Timeline

• Start date: 2018-02-22
• Primary completion: 2022-07-28
• Completion: 2022-07-28
• First posted: 2017-03-17
• Last updated: 2023-03-09

Locations

5 sites across 3 countries: Germany, Netherlands, United Kingdom