Summary
|
|
---|---|
EudraCT Number: | 2007-001394-29 |
Sponsor's Protocol Code Number: | 31998 |
National Competent Authority: | Austria - BASG |
Clinical Trial Type: | EEA CTA |
Trial Status: | Completed |
Date on which this record was first entered in the EudraCT database: | 2007-12-14 |
Trial results | View results |
Expand All
Collapse All
A. Protocol Information
|
|||
---|---|---|---|
A.1 | Member State Concerned | Austria - BASG | |
A.2 | EudraCT number | 2007-001394-29 | |
A.3 | Full title of the trial |
|
|
A.3.2 | Name or abbreviated title of the trial where available |
|
|
A.4.1 | Sponsor's protocol code number | 31998 | |
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
|
||
---|---|---|
B.Sponsor: 1 | ||
B.1.1 | Name of Sponsor | BAXTER HEALTHCARE CORPORATION |
B.1.3.4 | Country | United States |
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 | |
B.4.2 | Country | |
B.5 Contact point designated by the sponsor for further information on the trial | ||
B.5.1 | Name of organisation | |
B.5.2 | Functional name of contact point |
D. IMP Identification
|
||
---|---|---|
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 | Yes |
D.2.1.1.1 | Trade name | EXTRANEAL - Peritonealdialyselösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Vertriebs GmbH, 1031 Wien |
D.2.1.2 | Country which granted the Marketing Authorisation | Austria |
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 | Extraneal |
D.3.4 | Pharmaceutical form | Solution for peritoneal dialysis |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intraperitoneal use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Icodextrin |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 75 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium chloride |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.4 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium lactate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Calcium chloride dihydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.257 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Magnesium chloride hexahydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.051 |
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) | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | Yes |
D.2.1.1.1 | Trade name | Nutrineal PD4 mit 1,1% Aminosäuren - Peritonealdialyselösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Vertriebs GmbH, Wien |
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 | Nutrineal |
D.3.4 | Pharmaceutical form | Solution for peritoneal dialysis |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intraperitoneal use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | L-Tyrosin |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.300 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | L-Tryptophan |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.270 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | L-Phenylalanine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.570 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | L-Threonin |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.646 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | L-Serin |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.510 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | L-Prolin |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.595 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glycin |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.3 | Concentration number | 0.510 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | L-Alanin |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.951 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | L-Valin |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.393 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | L-Methionin |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.850 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | L-Isoleucin |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.850 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | L-Leucin |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.020 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | L-Lysin Hydrochloride |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.955 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | L-Histidin |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.714 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | L-Arginin |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.071 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium chloride |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.380 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Calcium chloride dihydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.184 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Magnesium chloride hexahydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.051 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium lactate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4.48 |
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) | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | Physioneal 35 Glucose 1,36 % w/v / 13,6 mg/ml - Peritonealdialyselösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Vertriebs GmbH, 1031 Wien |
D.2.1.2 | Country which granted the Marketing Authorisation | Austria |
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 | Physioneal 35 Glucose 1.36% |
D.3.4 | Pharmaceutical form | Solution for peritoneal dialysis |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intraperitoneal use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glucose monohydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 15.0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium chloride |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.67 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Calcium chloride dihydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.257 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Magnesium chloride hexahydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.051 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium bicarbonate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.10 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium (S)-lactate solution |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.12 |
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) | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | Physioneal 35 Glucose 2,27 % w/v / 22,7 mg/ml - Peritonealdialyselösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Vertriebs GmbH, 1031 Wien |
D.2.1.2 | Country which granted the Marketing Authorisation | Austria |
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 | Physioneal 35 Glucose 2.27% |
D.3.4 | Pharmaceutical form | Solution for peritoneal dialysis |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intraperitoneal use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glucose monohydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 25.0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium chloride |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.67 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Calcium chloride dihydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.257 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Magnesium chloride hexahydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.051 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium (S)-lactate solution |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.12 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium bicarbonate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.10 |
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) | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | Physioneal 40 Glucose 1,36 % w/v / 13,6 mg/ml - Peritonealdialyselösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Vertriebs GmbH, 1031 Wien |
D.2.1.2 | Country which granted the Marketing Authorisation | Austria |
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 | Physioneal 40 Glucose 1.36% |
D.3.4 | Pharmaceutical form | Solution for peritoneal dialysis |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intraperitoneal use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glucose monohydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 15.0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium chloride |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.38 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Calcium chloride dihydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.184 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Magnesium chloride hexahydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.051 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium bicarbonate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.10 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium (S)-lactate solution |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.68 |
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) | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | 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 | Physioneal 40 Glucose 2,27 % w/v / 22,7 mg/ml - Peritonealdialyselösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Vertriebs GmbH, 1031 Wien |
D.2.1.2 | Country which granted the Marketing Authorisation | Austria |
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 | Physioneal 40 Glucose 2.27% |
D.3.4 | Pharmaceutical form | Solution for peritoneal dialysis |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intraperitoneal use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glucose monohydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 25.0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium chloride |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.38 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Calcium chloride dihydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.184 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Magnesium chloride hexahydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.051 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium bicarbonate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.10 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium (S)-lactate solution |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.68 |
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) | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | 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 | Physioneal 40 Glucose 3,86 % w/v / 38,6 mg/ml - Peritonealdialyselösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Vertriebs GmbH, 1031 Wien |
D.2.1.2 | Country which granted the Marketing Authorisation | Austria |
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 | Physioneal 40 Glucose 3.86% |
D.3.4 | Pharmaceutical form | Solution for peritoneal dialysis |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intraperitoneal use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glucose monohydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 42.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium chloride |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.38 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Calcium chloride dihydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.184 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Magnesium chloride hexahydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.051 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium bicarbonate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.10 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium (S)-lactate solution |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.68 |
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) | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
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 | Information not present in EudraCT |
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.2.1.1.1 | Trade name | Dianeal PD1 Glucose 1,36 % w/v/13,6 mg/ml - Peritonealdialyselösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Vertriebs GmbH, Wien |
D.2.1.2 | Country which granted the Marketing Authorisation | Austria |
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 | Dianeal PD1 Glucose 1.27% |
D.3.4 | Pharmaceutical form | Solution for peritoneal dialysis |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intraperitoneal use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glucose anhydrous |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 13.6 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium chloride |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.67 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Calcium chloride dihydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.257 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Magnesium chloride hexahydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.152 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium (S)-lactate solution |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.92 |
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) | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
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 | Information not present in EudraCT |
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: 9 | ||
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.2.1.1.1 | Trade name | Dianeal PD1 Glucose 2,27 % w/v/22,7 mg/ml - Peritonealdialyselösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Vertriebs GmbH, Wien |
D.2.1.2 | Country which granted the Marketing Authorisation | Austria |
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 | Dianeal PD1 Glucose 2.27% |
D.3.4 | Pharmaceutical form | Solution for peritoneal dialysis |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intraperitoneal use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glucose anhydrous |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 22.7 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium chloride |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.67 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Calcium chloride dihydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.257 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Magnesium chloride hexahydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.152 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium (S)-lactate solution |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.92 |
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) | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
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 | Information not present in EudraCT |
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: 10 | ||
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.2.1.1.1 | Trade name | Dianeal PD1 Glucose 3,86 % w/v/38,6 mg/ml - Peritonealdialyselösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Vertriebs GmbH, Wien |
D.2.1.2 | Country which granted the Marketing Authorisation | Austria |
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 | Dianeal PD1 Glucose 3.86% |
D.3.4 | Pharmaceutical form | Solution for peritoneal dialysis |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intraperitoneal use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glucose anhydrous |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 38.6 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium chloride |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.67 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Calcium chloride dihydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.257 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Magnesium chloride hexahydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.152 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium (S)-lactate solution |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.92 |
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) | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
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 | Information not present in EudraCT |
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: 11 | ||
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.2.1.1.1 | Trade name | Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml - Peritonealdialyselösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Vertriebs GmbH, Wien |
D.2.1.2 | Country which granted the Marketing Authorisation | Austria |
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 | Dianeal PD4 Glucose 1.36% |
D.3.4 | Pharmaceutical form | Solution for peritoneal dialysis |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intraperitoneal use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glucose anhydrous |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 13.6 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium chloride |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.38 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Calcium chloride dihydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.184 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Magnesium chloride hexahydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.051 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium (S)-lactate solution |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4.48 |
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) | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
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 | Information not present in EudraCT |
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: 12 | ||
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.2.1.1.1 | Trade name | Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml - Peritonealdialyselösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Vertriebs GmbH, Wien |
D.2.1.2 | Country which granted the Marketing Authorisation | Austria |
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 | Dianeal PD4 Glucose 2.27% |
D.3.4 | Pharmaceutical form | Solution for peritoneal dialysis |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intraperitoneal use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glucose anhydrous |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 22.7 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium chloride |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.38 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Calcium chloride dihydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.184 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Magnesium chloride hexahydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.051 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium (S)-lactate solution |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4.48 |
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) | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
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 | Information not present in EudraCT |
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: 13 | ||
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.2.1.1.1 | Trade name | Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml - Peritonealdialyselösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Vertriebs GmbH, Wien |
D.2.1.2 | Country which granted the Marketing Authorisation | Austria |
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 | Dianeal PD4 Glucose 3.86% |
D.3.4 | Pharmaceutical form | Solution for peritoneal dialysis |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intraperitoneal use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glucose anhydrous |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 38.6 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium chloride |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.38 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Calcium chloride dihydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.184 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Magnesium chloride hexahydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.051 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium (S)-lactate solution |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4.48 |
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) | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
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 | Information not present in EudraCT |
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: 14 | ||
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 | PHYSIONEAL 35 Glucose 3,86 % w/v / 38,6 mg/ml - Peritonealdialyselösung |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Vertriebs GmbH, 1031 Wien |
D.2.1.2 | Country which granted the Marketing Authorisation | Austria |
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 | Physioneal 35 Glucose 3.86% |
D.3.4 | Pharmaceutical form | Solution for peritoneal dialysis |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intraperitoneal use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glucose monohydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 42.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium chloride |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.67 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Calcium chloride dihydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.257 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Magnesium chloride hexahydrate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.051 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium bicarbonate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.10 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Sodium (S)-lactate solution |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.12 |
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) | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.13 | Another type of medicinal product | No |
D.8 Information on Placebo
|
---|
E. General Information on the Trial
|
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
E.1 Medical condition or disease under investigation | ||||||||||||||
E.1.1 | Medical condition(s) being investigated |
|
||||||||||||
MedDRA Classification | ||||||||||||||
E.1.2 Medical condition or disease under investigation | ||||||||||||||
|
||||||||||||||
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 | 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 | Yes | ||||||||||||
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) | No | ||||||||||||
E.7.4 | Therapeutic use (Phase IV) | Yes | ||||||||||||
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 | Yes | ||||||||||||
E.8.1.6 | Cross over | No | ||||||||||||
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) | Yes | ||||||||||||
E.8.2.2 | Placebo | No | ||||||||||||
E.8.2.3 | Other | Yes | ||||||||||||
E.8.2.3.1 | Comparator description |
|
||||||||||||
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 | ||||||||||||
E.8.5 | The trial involves multiple Member States | Yes | ||||||||||||
E.8.5.1 | Number of sites anticipated in the EEA | 39 | ||||||||||||
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 |
|
||||||||||||
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 | 2 | ||||||||||||
E.8.9.1 | In the Member State concerned months | 0 | ||||||||||||
E.8.9.1 | In the Member State concerned days | 0 | ||||||||||||
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 | 0 | ||||||||||||
E.8.9.2 | In all countries concerned by the trial days | 0 |
F. Population of Trial Subjects
|
|||
---|---|---|---|
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) | Yes | |
F.1.3 | Elderly (>=65 years) | Yes | |
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 | No | |
F.3.3.7 | Others | No | |
F.4 Planned number of subjects to be included | |||
F.4.1 | In the member state | 15 | |
F.4.2 | For a multinational trial | ||
F.4.2.1 | In the EEA | 94 | |
F.4.2.2 | In the whole clinical trial | 236 | |
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) |
|
G. Investigator Networks to be involved in the Trial
|
---|
N. Review by the Competent Authority or Ethics Committee in the country concerned
|
||
---|---|---|
N. | Competent Authority Decision | Authorised |
N. | Date of Competent Authority Decision | 2008-01-09 |
N. | Ethics Committee Opinion of the trial application | Favourable |
N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion |
|
N. | Date of Ethics Committee Opinion | 2008-01-09 |
P. End of Trial
|
||
---|---|---|
P. | End of Trial Status | Completed |