Summary
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EudraCT Number: | 2014-000565-47 |
Sponsor's Protocol Code Number: | BAY59-7939/14372 |
National Competent Authority: | Finland - Fimea |
Clinical Trial Type: | EEA CTA |
Trial Status: | Completed |
Date on which this record was first entered in the EudraCT database: | 2015-08-31 |
Trial results | View results |
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A. Protocol Information
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A.1 | Member State Concerned | Finland - Fimea | |
A.2 | EudraCT number | 2014-000565-47 | |
A.3 | Full title of the trial |
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A.3.1 | Title of the trial for lay people, in easily understood, i.e. non-technical, language |
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A.3.2 | Name or abbreviated title of the trial where available |
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A.4.1 | Sponsor's protocol code number | BAY59-7939/14372 | |
A.7 | Trial is part of a Paediatric Investigation Plan | Yes | |
A.8 | EMA Decision number of Paediatric Investigation Plan | P/084/2014 |
B. Sponsor Information
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B.Sponsor: 1 | ||
B.1.1 | Name of Sponsor | Bayer AG |
B.1.3.4 | Country | Germany |
B.3.1 and B.3.2 | Status of the sponsor | Commercial |
B.4 Source(s) of Monetary or Material Support for the clinical trial: | ||
B.4.1 | Name of organisation providing support | Bayer AG |
B.4.2 | Country | Germany |
B.5 Contact point designated by the sponsor for further information on the trial | ||
B.5.1 | Name of organisation | Bayer AG |
B.5.2 | Functional name of contact point | Bayer Clinical Trials Contact |
B.5.3 | Address: | |
B.5.3.1 | Street Address | - |
B.5.3.2 | Town/ city | Berlin |
B.5.3.3 | Post code | 13342 |
B.5.3.4 | Country | Germany |
B.5.4 | Telephone number | +4930300139003 |
B.5.6 | clinical-trials-contact@bayer.com |
D. IMP Identification
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D.IMP: 1 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | No |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | Xarelto |
D.3.2 | Product code | BAY59-7939 |
D.3.4 | Pharmaceutical form | Film-coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | RIVAROXABAN |
D.3.9.1 | CAS number | 366789-02-8 |
D.3.9.2 | Current sponsor code | BAY 59-7939 |
D.3.9.4 | EV Substance Code | SUB29263 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 2 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | No |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | Xarelto |
D.3.2 | Product code | BAY59-7939 |
D.3.4 | Pharmaceutical form | Film-coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | RIVAROXABAN |
D.3.9.1 | CAS number | 366789-02-8 |
D.3.9.2 | Current sponsor code | BAY 59-7939 |
D.3.9.4 | EV Substance Code | SUB29263 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 7.5 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 3 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Xarelto 10 mg |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Bayer AG |
D.2.1.2 | Country which granted the Marketing Authorisation | European Union |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | Xarelto |
D.3.2 | Product code | BAY59-7939 |
D.3.4 | Pharmaceutical form | Film-coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | RIVAROXABAN |
D.3.9.1 | CAS number | 366789-02-8 |
D.3.9.2 | Current sponsor code | BAY 59-7939 |
D.3.9.4 | EV Substance Code | SUB29263 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 4 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Xarelto 15 mg |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Bayer AG |
D.2.1.2 | Country which granted the Marketing Authorisation | European Union |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | Xarelto |
D.3.2 | Product code | BAY59-7939 |
D.3.4 | Pharmaceutical form | Film-coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | RIVAROXABAN |
D.3.9.1 | CAS number | 366789-02-8 |
D.3.9.2 | Current sponsor code | BAY 59-7939 |
D.3.9.4 | EV Substance Code | SUB29263 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 15 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 5 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Xarelto 20 mg |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Bayer AG |
D.2.1.2 | Country which granted the Marketing Authorisation | European Union |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | Xarelto |
D.3.2 | Product code | BAY59-7939 |
D.3.4 | Pharmaceutical form | Film-coated tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | RIVAROXABAN |
D.3.9.1 | CAS number | 366789-02-8 |
D.3.9.2 | Current sponsor code | BAY 59-7939 |
D.3.9.4 | EV Substance Code | SUB29263 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 20 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 6 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | fondaparinux |
D.3.4 | Pharmaceutical form | Solution for injection |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Subcutaneous use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | FONDAPARINUX SODIUM |
D.3.9.1 | CAS number | 114870-03-0 |
D.3.9.4 | EV Substance Code | SUB12504MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg/kg milligram(s)/kilogram |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.1 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 7 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | vitamin K antagonist |
D.3.4 | Pharmaceutical form | Tablet |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | WARFARIN |
D.3.9.1 | CAS number | 81-81-2 |
D.3.9.4 | EV Substance Code | SUB00090MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | depend on patient |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 8 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | low molecular weight heparin |
D.3.4 | Pharmaceutical form | Solution for injection |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Subcutaneous use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Enoxaparin |
D.3.9.1 | CAS number | MI08400000 |
D.3.9.3 | Other descriptive name | LOW MOLECULAR WEIGHT HEPARIN |
D.3.9.4 | EV Substance Code | SUB91573 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg/ml milligram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | depend to patient |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | No |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | Yes |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | Yes |
D.3.11.13.1 | Other medicinal product type | Low-molecular-weight heparin |
D.IMP: 9 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | No |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | Xarelto |
D.3.2 | Product code | BAY59-7939 |
D.3.4 | Pharmaceutical form | Granules for oral suspension |
D.3.4.1 | Specific paediatric formulation | Yes |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | RIVAROXABAN |
D.3.9.1 | CAS number | 366789-02-8 |
D.3.9.2 | Current sponsor code | BAY 59-7939 |
D.3.9.4 | EV Substance Code | SUB29263 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg/ml milligram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Yes |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
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 |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] | ||||||||||||||||||||||||||||||
MedDRA Classification | ||||||||||||||||||||||||||||||||
E.1.2 Medical condition or disease under investigation | ||||||||||||||||||||||||||||||||
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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 |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No | ||||||||||||||||||||||||||||||
E.3 | Principal inclusion criteria |
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E.4 | Principal exclusion criteria |
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E.5 End points | ||||||||||||||||||||||||||||||||
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes | ||||||||||||||||||||||||||||||
E.6.5 | Efficacy | Yes | ||||||||||||||||||||||||||||||
E.6.6 | Pharmacokinetic | Yes | ||||||||||||||||||||||||||||||
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) | 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 | Yes | ||||||||||||||||||||||||||||||
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) | Yes | ||||||||||||||||||||||||||||||
E.8.2.2 | Placebo | No | ||||||||||||||||||||||||||||||
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 | 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.8.5.1 | Number of sites anticipated in the EEA | 50 | ||||||||||||||||||||||||||||||
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 | No | ||||||||||||||||||||||||||||||
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 | Yes | ||||||||||||||||||||||||||||||
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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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 | |||||||||||||||||||||||||||||||
E.8.9.2 | In all countries concerned by the trial years | 5 | ||||||||||||||||||||||||||||||
E.8.9.2 | In all countries concerned by the trial months | 2 |
F. Population of Trial Subjects
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F.1 Age Range | |||
F.1.1 | Trial has subjects under 18 | Yes | |
F.1.1 | Number of subjects for this age range: | 170 | |
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) | Yes | |
F.1.1.3.1 | Number of subjects for this age range: | 12 | |
F.1.1.4 | Infants and toddlers (28 days-23 months) | Yes | |
F.1.1.4.1 | Number of subjects for this age range: | 20 | |
F.1.1.5 | Children (2-11years) | Yes | |
F.1.1.5.1 | Number of subjects for this age range: | 50 | |
F.1.1.6 | Adolescents (12-17 years) | Yes | |
F.1.1.6.1 | Number of subjects for this age range: | 100 | |
F.1.2 | Adults (18-64 years) | No | |
F.1.3 | Elderly (>=65 years) | No | |
F.2 Gender | |||
F.2.1 | Female | Yes | |
F.2.2 | Male | Yes | |
F.3 Group of trial subjects | |||
F.3.1 | Healthy volunteers | No | |
F.3.2 | Patients | Yes | |
F.3.3 | Specific vulnerable populations | Yes | |
F.3.3.1 | Women of childbearing potential not using contraception | No | |
F.3.3.2 | Women of child-bearing potential using contraception | Yes | |
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 | Yes | |
F.3.3.6.1 | Details of subjects incapable of giving consent |
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F.3.3.7 | Others | Yes | |
F.3.3.7.1 | Details of other specific vulnerable populations |
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F.4 Planned number of subjects to be included | |||
F.4.1 | In the member state | 3 | |
F.4.2 | For a multinational trial | ||
F.4.2.1 | In the EEA | 90 | |
F.4.2.2 | In the whole clinical trial | 170 | |
F.5 | Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition) |
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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 | 2015-09-02 |
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 | 2015-08-27 |
P. End of Trial
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P. | End of Trial Status | Completed |
P. | Date of the global end of the trial | 2019-01-30 |