Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0237109527
Study information
Scientific title
Acronym
Study hypothesis
The aims of this study are to examine the two null hypotheses stated below and, as a secondary measure, to evaluate the relationship between urinary protein excretion and vascular compliance.
1. There is no difference in the effect of ramipril or irbesartan on vascular compliance measurements in subjects with type 2 diabetes complicated with nephropathy
2. Combination therapy with ramipril and irbesartan does not confer any additional effect on vascular compliance when compared to each drug used in isolation
Ethics approval
Not provided at time of registration
Study design
Randomised double blind controlled crossover group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Vascular compliance
Intervention
Please not that as of 22/09/09 the status of this trial has been changed to "Stopped". The trial did not commence due to funding and resource issues
Double blind randomised cross over design clinical trial. Subjects will be randomised to receive an angiotensin converting enzyme (ACE) inhibitor, ramipril plus placebo, or AT2 receptor antagonist, irbesartan plus placebo, or ramipril plus irbesartan for 6 weeks in maximum doses.
Intervention type
Drug
Phase
Not Specified
Drug names
Ramipiril, irbesartan
Primary outcome measures
1. Vascular compliance
2. Blood pressure
3. 24 h protein excretion
4. Adverse events
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2002
Overall trial end date
01/02/2004
Reason abandoned
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
42 Patients over 18 years of age.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
42
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/02/2002
Recruitment end date
01/02/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Research Registrar
Prescot, Merseyside
L35 5DR
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
St Helens and Knowsley Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary