Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shirley Hulme

ORCID ID

Contact details

Diabetes Centre
Whiston Hospital
Prescot
L35 5DR
United Kingdom
+44 (0)151 426 1600

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0237101856

Study information

Scientific title

Acronym

Study hypothesis

The aim of the study is to evaluate the impact on blood pressure control, patient satisfaction and well being and adherence to medication of conventional gradual titration of anti-hypertensive treatment versus rapid introduction and dose escalation of four anti-hypertensive agents in subjects with diabetic nephropathy.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial, open design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular: Hypertension

Intervention

Standard versus rapid initiation of anti-hypertensive therapy

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Patient adherence to treatment
2. Blood pressure
3. Proteinuria
4. Adverse events
5. Treatment satisfaction

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2001

Overall trial end date

01/04/2004

Reason abandoned

Eligibility

Participant inclusion criteria

24 subjects recruited from new patients entering the nephropathy clinic

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

24

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2001

Recruitment end date

01/04/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Diabetes Centre
Prescot
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

Government

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