Ignite Creation Date:
2025-12-18 @ 9:57 AM
Ignite Modification Date:
2025-12-23 @ 10:58 PM
Study NCT ID:
NCT03082014
Status:
None
Last Update Posted:
2023-03-09 00:00:00
First Post:
2017-03-08 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Amlodipine and Other Blood Pressure Lowering Agents on Microvascular Function
Sponsor:
None
Organization:
Study Overview
Official Title:
EffecTs of Amlodipine and Other Blood PREssure Lowering Agents on Microvascular FuncTion in Small Vessel Diseases
Status:
None
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
completed for the primary study group of sporadic SVD patients, halted prematurely for the additional study group due to slow recruitment at 26 of 30 CADASIL patients in December 2022
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREAT-SVDs
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: