E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
At undersøge i et randomiseret, placebokontrolleret, dobbeltblindet interventionsforsøg, om tillæg af spironolakton til anden antihypertensiv behandling af behandlingsresistente hypertonikere med type 2 diabetes mellitus kan reducere blodtrykket. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005727 |
E.1.2 | Term | Blood pressure |
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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 |
At undersøge i et randomiseret, placebokontrolleret, dobbeltblindet interventionsforsøg, om tillæg af spironolakton til anden antihypertensiv behandling af behandlingsresistente hypertonikere med type 2 diabetes mellitus kan reducere blodtrykket |
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E.2.2 | Secondary objectives of the trial |
At undersøge hvor mange, der ved tillæg af spironolakton når et behandlingsmål på < 130/80 mmHg. At undersøge om tillæg af spironolakton påvirker insulinfølsomhed bestemt ved HOMA-IR og glykæmisk kontrol bestemt ved HbA1c
At undersøge om tillæg af spironolakton ændrer proteinudskillelsen i urin målt som albumin/creatinin ratio. At undersøge forekomsten af bivirkninger ved spironolaktonbehandlingen som hyperkaliæmi, gynækomasti, hovedpine, diarre, dyspepsi, impotens og menstruationsforstyrrelser |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Alder < 75 år 2. Type 2 diabetes karakteriseret ved: a) debut efter 30 års alderen b) ikke behov for insulin det første år. 3. Negativ graviditetstest for fertile kvinder ved inklusionen, samt sikker antikonception under forsøget, dvs. p-piller, spiral eller depot gestagen 4. Behandlingsresistent hypertension defineret ved a) BT ≥ 130/80 mmHg verificeret ved ABPM og b) Behandling af hypertension med mindst 3-stoffer med optimal dosis af ACEI eller ARB, thiazid eller indapamid samt et 3. antihypertensivum (ikke spironolacton eller amilorid).
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E.4 | Principal exclusion criteria |
1. HbA1c > 10,0 2. BT > 180/110 mmHg ved konsultationsmåling eller > 170/85 mmHg målt som gennemsnit af dagværdierne fra ABPM. 3. Ændring i antidiabetisk behandling i foregående 1 måned, fraset insulinjustering med mindre end 10 % ændring af den totale insulindosis. 4. Type 1 diabetes 5. Kendt sekundær hypertension forårsaget af a) obstruktiv søvnapnø b) primær hyperaldosteronisme, fæokromacytom, cushings syndrom c) kronisk nyresygdom (estimeret GFR < 50 ml/min) d) Nyrearteriestenose e) Coarctatio aortae teriestenose, coractatio aorta 6. Tidligere intolerance over for spironolacton 7. Medicin: Fast behandling med NSAID og glukokortikoider 8. Svær dyslipidæmi: total cholesterol > 10 mmol/l og/eller total triglycerid > 8 mmol/l 9. NYHA klasse III og IV 10. Gravide eller patienter der har planlagt graviditet i under¬søgelsesperioden 11. Psykisk sygdom som gør, at pt. ikke kan gennemføre protokollen 12. Klinisk relevant organisk eller systemisk sygdom inkl. malign lidelse 13. Forventning om manglende samarbejde eller manglende forståelse af forsøget
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E.5 End points |
E.5.1 | Primary end point(s) |
Ændring i blodtryk (systolisk og diastolisk) fra før til efter intervention |
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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 | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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
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The trial ends when the last inroled partipicipant has completed the trial period. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |