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ISRCTN
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ISRCTN21821912
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ClinicalTrials.gov identifier
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Public title
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Double blind, randomised controlled cross over trial comparing the antihypertensive effects of amiloride and spironolactone in black hypertensives with and without the T594M mutation
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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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PG/2001084
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Study hypothesis
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Not provided at time of registration
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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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Hypertension
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Participants - inclusion criteria
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1. Hypertensives of African origin
2. Subjects with the T594M polymorphism and controls with the wild-type sodium channel
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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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01/01/2002
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Anticipated end date
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31/12/2002
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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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Not provided at time of registration
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Interventions
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1. Amiloride 5 mg bd for 2 weeks, increased to 10 mg bd for further 6 weeks. Then cross over to spironolactone as below, then to a combination of amiloride 5 mg bd plus spironolactone 25 mg bd
2. Spironolactone 25 mg bd for 2 weeks then increased to 50 mg bd for further 6 weeks. Then cross over to amiloride as above, then to a combination of amiloride 5 mg bd plus spironolactone 25 mg bd
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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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British Heart Foundation (UK)
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Trial website
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Publications
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Contact name
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Dr
PA
Swift
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Address
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Blood Pressure Unit
Department of Physiological Medicine
St George's Hospital Medical School
Cranmer Terrace
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City/town
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London
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Zip/Postcode
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SW17 0RE
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Country
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United Kingdom
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Tel
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+44 (0)20 8725 3176
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Fax
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+44 (0)20 8725 2959
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Email
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pswift@sghms.ac.uk
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Sponsor
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British Heart Foundation (UK)
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Address
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14 Fitzhardinge Street
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City/town
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London
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Zip/Postcode
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W1H 6DH
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Country
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United Kingdom
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Tel
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+44 (0)20 7935 0185
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Fax
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+44 (0)20 7486 5820
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Email
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research@bhf.org.uk
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Sponsor website:
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http://www.bhf.org.uk/
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Date applied
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08/03/2002
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Last edited
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18/12/2007
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Date ISRCTN assigned
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08/03/2002
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