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 |
Efficacy of the investigational CAPD solution balance low sodium when compared to the registered CAPD Solution balance as an active control, in double blinded testing |
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E.2.2 | Secondary objectives of the trial |
Safety on the investigational CAPD solution balance low sodium when compared to the registered CAPD Solution balance as an active control, in double blinded testing Cardiovascular effects of balance low sodium solution as defined by changes on blood pressure, changes on the number or dosage of anti-hypertensive drugs as well as changes in serum markers related to the cardiovascular system Effects of balance low sodium solutin on sodium balance as defined by daily dietetic sodium uptake and daily sodium excretion Quality-of-life |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Adult CAPD patiens >= 18 years Patients with at least 3 months experience on CAPD prior to inclusion Patients treated with registered balance solution for at least 4 weeks prior to inclusion Patients receiving at least one anti-hypertensive drug (incl. diuretics) or showing a systolic office blood pressure of >=130 mmHg, defined by the mean of two measurements in seated position with 5 minutes in between each measurement Signed and dated informed consent by study patient and investigator/authorised physician |
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E.4 | Principal exclusion criteria |
Patients with known medical history of recurrent severe hyponatremia <130 mmol/L Peritonitis treatment <=4 weeks preceding inclusion Malignant disease without remission women of childbearing potential without effective means of contraception, pregnancy, lactation period Active HBV or HCV infection HIV positive Participation in another interventional clinical study during the preceding 30 days Previous participation in the same study Planned travel activities outiside the participating countries (Austria, Germany, Poland and the Netherlands) if the study medication cannot be transported by the patient himself |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
balance solution with 134 mmol sodium/l |
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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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | |
E.8.9.1 | In the Member State concerned months | 15 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 18 |