Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/05/2014
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 Kevin M O'Shaugnessy

ORCID ID

Contact details

Box No 110
Clinical Pharmacology Unit
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 245151 ext.2894
kmo22@medschl.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544099293

Study information

Scientific title

Acronym

Study hypothesis

This will be a study in patients with Polycystic Kidney Disease (PKD) and hypertension designed to evaluate:
1. Individual responsiveness to 5 main drug groups:
1.1. Angiotensin Converting Enzyme (ACE)-inhibitor
1.2. Alpha-blockade
1.3. Beta-blockade
1.4. Diuretic
1.5. Calcium antagonist, and
2. Whether lowering blood pressure improves quality of life, Left Ventricular (LV) mass and endothelial function in PKD patients with mild/moderate hypertension and normal renal function.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular: Hypertension

Intervention

Following a 2-week placebo run-in period, patients eligible to enter this crossover, double-blind study will receive in a randomised order, daily, and for a six week period:
1. Amlodipine (5 mg)
2. Doxazosin (1 mg increasing to 4 mg)
3. Lisinopril (2.5 mg increasing to 10 mg)
4. Benrofluazide (2.5 mg)
5. Bisoprolol (5 mg)
6. Placebo

Patients will then receive an additional six weeks treatment with the agent that produced the greatest lowering of mean supine blood pressure.

Updated 16/05/2014: the trial was stopped in 2008 due to a lack of funding.

Intervention type

Drug

Phase

Not Specified

Drug names

Amlodipine, doxazosin, lisinopril, benrofluazide, bisoprolol

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

24/02/2000

Overall trial end date

24/02/2007

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant inclusion criteria

40 outpatients aged 18 - 65 years.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

24/02/2000

Recruitment end date

24/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box No 110
Cambridge
CB2 2QQ
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

Cambridge Consortium - Addenbrookes Hospital (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

British Heart Foundation (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Funder name

NHS R&D Support Funding (UK) (ref: 2007/08)

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