E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess efficacy, safety and tolerability of treating scleroderma renal crisis with bosentan. |
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E.2.2 | Secondary objectives of the trial |
To assess any difference in outcomes of those patients commenced on treatment within 10 days of onset of scleroderma renal crisis, compared with those treated later. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients with scleroderma renal crisis, requiring both of 1. New onset blood pressure >150/80 obtained twice over a 24 hour period 2. A documented decrease in renal function of at least 30% in the calculated glomerular filtration rate. Patients with diffuse or limited systemic sclerosis of any disease duration Age 18 or older Women must be postmenopausal, surgically or naturally sterile, or use a reliable form of contraception during study treatment during and for three months after completion of the study. Hormone based contraception alone are not regarded as a reliable form of contraception.
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E.4 | Principal exclusion criteria |
Previous use of an endothelin receptor antagonist Significant baseline abnormalities in liver function testing (biochemical markers more than 3 times upper limit of normal) Patients with moderate or severe hepatic impairment i.e. Child-Pugh class B or C Patients with body weight <40kg Patients with a systolic blood pressure <85 mm Hg Patients with conditions that prevent compliance with the protocol or failure to adhere to therapy Patients with any other life threatening condition. Patients with known hypersensitivity to bosentan, or any of the excipients of the formulation. Patients receiving glibenclamide, cyclosporin A, or tacrolimus within 1 week prior to screening, or expecting to receive any of these agents during the study. Patients who have received an investigational agent in the month preceding screening.
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E.5 End points |
E.5.1 | Primary end point(s) |
Creatinine clearance - baseline, minimum and at 6 and 12 months 24hr urinary protein - baseline, minimum and at 6 and 12 month Serum creatinine - baseline, minimum and at 6 and 12 months Dialysis duration Time to achieve control of hypertension Maintenance anti-hypertensive therapy at 6 and 12 months (number of anti-hypertensives)
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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 | Yes |
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 | Information not present in EudraCT |
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) | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
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 | 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
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The last visit of the last subject undergoing the trial |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |