Summary
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EudraCT Number: | 2008-007871-26 |
Sponsor's Protocol Code Number: | |
National Competent Authority: | Denmark - DHMA |
Clinical Trial Type: | EEA CTA |
Trial Status: | Completed |
Date on which this record was first entered in the EudraCT database: | 2009-01-29 |
Trial results |
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A. Protocol Information
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A.1 | Member State Concerned | Denmark - DHMA |
A.2 | EudraCT number | 2008-007871-26 |
A.3 | Full title of the trial | |
A.4.1 | Sponsor's protocol code number | |
A.7 | Trial is part of a Paediatric Investigation Plan | Information not present in EudraCT |
A.8 | EMA Decision number of Paediatric Investigation Plan |
B. Sponsor Information
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D. IMP Identification
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D.8 Information on Placebo
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E. General Information on the Trial
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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 | |
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | |
E.4 | Principal exclusion criteria | |
E.5 End points | ||
E.5.1 | Primary end point(s) | |
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 | 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) | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
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 | 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 | |
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 | |
E.8.9.1 | In the Member State concerned days |
F. Population of Trial Subjects
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F.1 Age Range | ||
F.1.1 | Trial has subjects under 18 | No |
F.1.1.1 | In Utero | No |
F.1.1.2 | Preterm newborn infants (up to gestational age < 37 weeks) | No |
F.1.1.3 | Newborns (0-27 days) | No |
F.1.1.4 | Infants and toddlers (28 days-23 months) | No |
F.1.1.5 | Children (2-11years) | No |
F.1.1.6 | Adolescents (12-17 years) | No |
F.1.2 | Adults (18-64 years) | No |
F.1.3 | Elderly (>=65 years) | No |
F.2 Gender | ||
F.2.1 | Female | No |
F.2.2 | Male | No |
F.3 Group of trial subjects | ||
F.3.1 | Healthy volunteers | No |
F.3.2 | Patients | No |
F.3.3 | Specific vulnerable populations | No |
F.3.3.1 | Women of childbearing potential not using contraception | No |
F.3.3.2 | Women of child-bearing potential using contraception | No |
F.3.3.3 | Pregnant women | No |
F.3.3.4 | Nursing women | No |
F.3.3.5 | Emergency situation | No |
F.3.3.6 | Subjects incapable of giving consent personally | No |
F.3.3.7 | Others | No |
F.4 Planned number of subjects to be included | ||
F.4.1 | In the member state |
G. Investigator Networks to be involved in the Trial
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N. Review by the Competent Authority or Ethics Committee in the country concerned
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N. | Competent Authority Decision | Authorised |
N. | Date of Competent Authority Decision | 2009-02-23 |
N. | Ethics Committee Opinion of the trial application | Favourable |
N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion |
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N. | Date of Ethics Committee Opinion | 2009-02-19 |
P. End of Trial
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P. | End of Trial Status | Completed |
P. | Date of the global end of the trial | 2014-03-17 |