E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Physiological responses in patients with essential hypertension |
Fysiologiske effekter hos patienter med essentiel hypertension |
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E.1.1.1 | Medical condition in easily understood language |
Physiological responses in patients with high blood pressuee |
Fysiologiske effekter hos patienter med forhøjet blodtryk |
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E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10022891 |
E.1.2 | Term | Investigations |
E.1.2 | System Organ Class | 10022891 - Investigations |
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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 |
To investigate the effect af treatment with spironolactone for 4 weeks renal hemodynamics in patients with essentiel hypertension |
At undersøge effekten af 4 ugers behandling med spironolakton på renal hæmodynamik hos patienter med essentiel hypertension med specielt fokus på nyrernes blodgennemstrømning. |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Ikke relevant |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
40-80 years, BMI 18,5-30,0 kg/m2, fertile women must use contraception, hypertension, signed consent form |
40-80 år, DMI 18,5-30,0 kg/m2, fertile kvinder skal anvende sikker prævention, forhøjet blodtryk, underskrevet samtykkeerklæring |
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E.4 | Principal exclusion criteria |
Alcohol abuse, substance abuse, tobacco smoking, cancer, pregnancy or nursing, diabetes mellitus, GFR < 60 ml/min, Albuminuria > 700 mg/l, clinically significant signs of lung-, liver-, metabolic or neurologic disorders, clinically significant abnormalities in screening blood tests, urine tests or ECG, clinical signs of secondary hypertension, treatment with more than 3 different types of antihypertensives, office blood pressure > 170/105 repeatedly despite regulaion og antihypertensive medicine, donation of blood within one month of the first examination day, uacceptable symptoms due to high blood pressure |
Alkoholoverforbrug, stofmisbrug, tobaksrygning, cancer, graviditet eller amning, diabetes mellitus, GFR < 60 ml/min, albuminuri > 700 mg/l, kliniske tegn på betydende lunge-, lever-, stofskiftesygdomme eller neurologiske lidelser, Klinisk betydende afvigelser ved screeningsblodprøver, urinstix eller EKG, Klinisk mistanke om sekundær hypertension, Behandling med > 3 forskellige blodtrykspræparater, Konsultationsblodtryk over 170/105 mmHg ved gentagne målinger på trods af regulering af den antihypertensive medicin, Bloddonation inden for den seneste måned inden først undersøgelsesdag på Medicinsk Forskningsafsnit, Uacceptable kliniske symptomer på forhøjet blodtryk
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E.5 End points |
E.5.1 | Primary end point(s) |
Renal blood flow |
Nyrernes blodgennemstrømning |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of the trial when all subjects have completed the trial |
Ved slutningen af forsøget, når alle deltagere har gennemført forsøget |
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E.5.2 | Secondary end point(s) |
Renal plasma flow Renal vascular resistance Brachial blood pressure and central aortic systolic blood pressure, pulsewavevelocity, vascular stiffness Creatinine clearance, filtrationfraction Plasma levels of renin, aldosteron, angiotensin 2, atrial natriuretic peptide, brain natriuretic peptide, cGMP, Nox, nitrate, nitrite, vasopressin, osmolality, potassium, sodium, creatinine, albumin Urinary excretion of cGMP, cAMP, aquaporin 2, Enac, NKCC2, Nox, nitrate, nitrite, osmolality, potassium, sodium, creatinine, albumin |
Renalt plasma flow Renal vaskulær resistance Brachialt blodtryk og centralt systolisk blodtryk ved aorta, hjertefrekvens, pulsbølgehastighed og karstivhed Plasmaniveauer af renin, aldosteron, angiotensin II (angII), atrialt natriuretisk peptid (ANP), brain natriuretisk peptid (BNP), cyklisk guanosin monofosfat (cGMP), NOx, nitrit, nitrat, vasopressin (AVP), p-Osmolalitet (osm), kalium, natrium, albumin, creatinin Creatinin-clearance, filtrationsfraktionen Urinudskillelse af cGMP, cyklisk adenosin monofosfat (cAMP), aquaporin-2 (AQP-2), Endothelielle natriumkanaler (ENaC) og Natrium-Kalium-Klorid cotransporter (NKCC2), NOx, nitrit og nitrat, U-Osmolalitet (osm), kalium, natrium, albumin, creatinin, diurese
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of the trial when all subjects have completed the trial |
Ved slutningen af forsøget, når alle deltagere har gennemført forsøget |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.6 | Cross over | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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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1 week after LVLS |
1 uge efter LVLS |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |