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ISRCTN
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ISRCTN57653760
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ClinicalTrials.gov identifier
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Public title
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A rotation study through the main therapeutic classes of antihypertensive in patients with polycystic kidney disease and hypertension
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0544099293
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular: Hypertension
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Participants - inclusion criteria
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40 outpatients aged 18 - 65 years.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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24/02/2000
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Anticipated end date
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24/02/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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40
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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1. Cambridge Consortium - Addenbrookes Hospital (UK)
2. British Heart Foundation (UK)
3. NHS R&D Support Funding (UK) (ref: 2007/08)
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Trial website
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Publications
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Contact name
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Dr
Kevin M
O'Shaugnessy
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Address
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Box No 110
Clinical Pharmacology Unit
Addenbrooke's NHS Trust
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QQ
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Country
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United Kingdom
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Tel
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+44 (0)1223 245151 ext.2894
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Email
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kmo22@medscl.cam.ac.uk
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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14/11/2007
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Date ISRCTN assigned
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12/09/2003
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