Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shirley Hulme

ORCID ID

Contact details

Research Registrar
St Helens & Knowsley Hospitals NHS Trust
Whiston Hospital
Prescot
Merseyside
L35 5DR
United Kingdom

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes