E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intermittent claudication (peripheral arterial disease) Fontaine’s stage II Deutsch: Periphere arterielle Verschlusskrankheit, Fontaine Staidum II |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062585 |
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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 assess the effect of nebivolol as compared to metoprolol on endothelial function by means of flow mediated dilation Deutsch: Untersuchung des Einflusses von Nebivolol vs. Metoprolol auf die Endothelfunktion mittels Fluss-mediierter Dilatation |
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E.2.2 | Secondary objectives of the trial |
to assess the effects of nebivolol as compared to metoprolol on: - functional arterial leg perfusion - systolic and diastolic blood pressure - erectile function (International Index of Erectile Function, IIEF) in males - quality of life (Claudication Scale / CLAU-S) - laboratory markers of cardiovascular risk and coagulation (hs-CRP, homocysteine, NT-proBNP, fibrinogen) - safety (adverse events, safety laboratory parameters, heart rate) Deutsch: Untersuchung des Einflusses von Nebivolol vs. Metoprolol auf: - die funktionelle Beindurchblutung - den Blutdruck - die erektile Funktion - die Lebensqualität - Laborparameter zur Einstufung des kardiovaskuläen Riskos und des Gerinnungsstatus (hs-CRP, NT-proBNP, Fibrinogen) - Sicherheit (unerwünschte Ereignisse, Sicherheitslaborparameter, Herzfrequenz) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- PAOD Fontaine’s stage IIa or IIb with - Stage I hypertension according to JNC (SBP 140-159 mmHg or DBP 90-99 mmHg) with or without antihypertensive treatment
Deutsch: - Periphere arterielle Verschlusskrankheit, Fonatine Stadium II a oder IIb - Hypertonie im Stadium I nach JNC (SBD 140 -159 mmHg oder DBD 90-99 mmHg) mit oder ohne aktuelle antihypertensive Therapie
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E.4 | Principal exclusion criteria |
- PAOD with rest pain or leg ulcer or gangrene - Concomitant treatment with drugs that may influence the outcome measures if not taken in stable doses during the study and within certain periods priot to enrolment or anticipated need of dose adjustments of those drugs during the study - Previous treatment with nebivolol or carvedilol - Contraindication to the study drugs Deutsch: - Periphere arterielle Verschlusskrankheit mit Ruheschmerz oder Beinulcus oder Gangrän - Begleittherapie mit Medikamenten, die die Outcome Untersuchungen in der Studie beeinflussen könnten, sofern diese nicht in stabilen Dosen während der Studie eingenommen werden und auch vor Studienbeginn für bestimmte Zeiträume stabil eingenommen wurden oder vorhersehbare Notwendigkeit einer Dosisänderung dieser Substanzen während der Studie - Vortherapie mit Nebivolol oder Carvedilol - Kontrainidkation gegen eines der Studienmedikamente |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the percent change of flow-mediated diameter measurement of the brachial artery between baseline and visit 7 (week 48) Deutsch: Das primäre Wirksamkeitskriterium ist die prozentuale Veränderung des Fluss-mediierten Durchmesser der A. brachialis zwischen Baseline und Visite 7 (Woche 48) |
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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 | 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) | Yes |
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 | 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.8.3 |
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
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See Study protocol Deutsch: s. Studienprotokoll |
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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 | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |