Essential hypertension
Conditions
Interventions
Trade Name: No trade name (Generic amiloride hydrochloride)
Product Name: Amiloride hydrochloride
Pharmaceutical Form: Tablet
Sponsors
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Our ongoing, previously approved study is a double-blind, placebo controlled, cross-over study, of approximately 66 patients in which each patient receives in random order, 4 weeks treatment with either Bendrofluazide 5-10mg daily, Atenolol 50-100mg daily or combination of Bendrofluazide 2.5-5.0mg and Atenolol 25-50mg daily. Patients who have completed the main part of the study will be invited to take part in an open label phase with 10mg of amiloride for 2 weeks increasing to 20mg amiloride for 2 weeks. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: All patients will have taken part in the previous study and the original exclusion criteria still therefore stand: Any patient already taking thiazide diuretics or beta blockers in whom these drugs cannot be switched to alternative drugs with similar or better blood pressure control. Any patient who is intolerant of these medications will be excluded from the study. Patients with gout, asthma or any other contraindications to the study drugs will be excluded. Women of child bearing age not using contraception. Volunteers with heart failure, liver failure, renal failure, terminal illnesses (e.g. cancer) Volunteers not able to give informed consent Patients with diabetes New exclusion criteria include: Patients with plasma potassium over 5.5mmol/l, concomitant use of other potassium sparing agents or potassium supplements, anuria, acute renal failure, severe progressive renal disease (ie patients at highest risk of hyperkalaemia) would all be excluded from this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Can the oral glucose tolerance test detect changes after 4 weeks treatment with the potassium sparing diuretic - amiloride hydrochloride?;Secondary Objective: Are metabolic changes different in patients treated with atenolol, bendroflumethiazide and amiloride?;Primary end point(s): Change in 2 hour glucose between amiloride treatment at 10mg vs 20mg vs baseline. | — |
Countries
United Kingdom
Outcome results
None listed