A rotation study through the main therapeutic classes of antihypertensive in patients with polycystic kidney disease and hypertension

ISRCTN	ISRCTN57653760
DOI	https://doi.org/10.1186/ISRCTN57653760
Secondary identifying numbers	N0544099293

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 16/05/2014

Recruitment status: Stopped
Overall study status: Stopped
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 Kevin M O'Shaugnessy
Scientific

Box No 110
Clinical Pharmacology Unit
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)1223 245151 ext.2894
Email	kmo22@medschl.cam.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Amlodipine, doxazosin, lisinopril, benrofluazide, bisoprolol
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	24/02/2000
Completion date	24/02/2007
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	40
Key inclusion criteria	40 outpatients aged 18 - 65 years.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	24/02/2000
Date of final enrolment	24/02/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Box No 110

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Cambridge Consortium - Addenbrookes Hospital (UK)

No information available

British Heart Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): the_bhf, The British Heart Foundation, BHF
Location: United Kingdom

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan