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

NCT03082014 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-03-09

No results posted yet for this study

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)

Conditions

  • Cerebral Small Vessel Diseases

Interventions

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

Sponsors & Collaborators

  • University of Edinburgh

    collaborator OTHER

  • Maastricht University Medical Center

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • University of Oxford

    collaborator OTHER

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Martin Dichgans, Prof. · Institute for Stroke and Dementia Research

  • Joanna Wardlaw, Prof. · Neuroimaging Sciences and Brain Research Imaging Centre

  • Robert van Oostenbrugge, Prof. · Maastricht University Medical Center (UM), Department of Neurology

  • Geert Jan Biessels, Prof. · UMC Utrecht Brain Center Robert Magnus (UMCU)

  • Peter Rothwell, Prof. · Nuffield Department of Clinical Neurosciences, Oxford (UOXF)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-22
Primary Completion
2022-07-28
Completion
2022-07-28

Countries

  • Germany
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03082014 on ClinicalTrials.gov