ISRCTN ISRCTN16286916
DOI https://doi.org/10.1186/ISRCTN16286916
Protocol serial number N0237101856
Sponsor Department of Health (UK)
Funder St Helens and Knowsley Hospitals NHS Trust (UK)
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
16/09/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Shirley Hulme
Scientific

Diabetes Centre
Whiston Hospital
Prescot
L35 5DR
United Kingdom

Phone +44 (0)151 426 1600

Study information

Primary study designInterventional
Study designRandomised controlled trial, open design
Secondary study designRandomised controlled trial
Scientific title
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCardiovascular: Hypertension
InterventionStandard versus rapid initiation of anti-hypertensive therapy
Intervention typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/04/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration24
Key inclusion criteria24 subjects recruited from new patients entering the nephropathy clinic
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/11/2001
Date of final enrolment01/04/2004

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Diabetes Centre
Prescot
L35 5DR
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan