E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Can the oral glucose tolerance test detect changes after 4 weeks treatment with the potassium sparing diuretic − amiloride hydrochloride? |
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E.2.2 | Secondary objectives of the trial |
Are metabolic changes different in patients treated with atenolol, bendroflumethiazide and amiloride? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in 2 hour glucose between amiloride treatment at 10mg vs 20mg vs baseline. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |