| Source of record | UK Trials |
| ISRCTN | ISRCTN21821912 |
| Date ISRCTN assigned | 08/03/2002 |
| Local reference number(s) | PG/2001084 |
| Public title | Double blind, randomised controlled cross over trial comparing the antihypertensive effects of amiloride and spironolactone in black hypertensives with and without the T594M mutation |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Hypertension |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Hypertensives of African origin
2. Subjects with the T594M polymorphism and controls with the wild-type sodium channel |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/2002 |
| Anticipated end date | 31/12/2002 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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 |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | British Heart Foundation (UK) |
| Sponsor name | British Heart Foundation (UK) |
| Sponsor details | 14 Fitzhardinge Street
London
United Kingdom
W1H 6DH |
| Sponsor telephone | +44 (0)20 7935 0185 |
| Sponsor fax | +44 (0)20 7486 5820 |
| Sponsor email | research@bhf.org.uk |
| Sponsor website | http://www.bhf.org.uk/ |
| Contact name | Dr PA Swift |
| Contact details | Blood Pressure Unit
Department of Physiological Medicine
St George's Hospital Medical School
Cranmer Terrace
London
United Kingdom
SW17 0RE |
| Contact telephone | +44 (0)20 8725 3176 |
| Contact fax | +44 (0)20 8725 2959 |
| Contact email | pswift@sghms.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN21821912 |
| Date last extracted from ISRCTN register | 17/04/2008 |
