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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019432-12 | EudraCT Number |
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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
| Synexus | OTHER |
| author! et al. BV | UNKNOWN |
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Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eprosartan | Experimental | Eprosartan + Placebo Eprosartan Mesylate |
|
| Eprosartan Mesylate | Active Comparator | Eprosartan Mesylate + Placebo Eprosartan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eprosartan | Drug | Eprosartan 450 mg |
| |
| Eprosartan Mesylate |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline | Change from baseline of diastolic blood pressure (DBP), sitting | 8 weeks |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Dmitri N. Kazei, MD | Abbott Healthcare Products B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 74062 | Berlin | 12627 | Germany | |||
| Site Reference ID/Investigator# 74066 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eprosartan | Eprosartan 450 mg + Placebo Eprosartan Mesylate |
| FG001 | Eprosartan Mesylate | Eprosartan Mesylate 600 mg + Placebo Eprosartan |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Eprosartan mesylate 600 mg |
|
|
| Placebo Eprosartan mesylate | Drug | Placebo Eprosartan mesylate |
|
|
| Placebo Eprosartan | Drug | Placebo Eprosartan |
|
|
| Bochum |
| 44787 |
| Germany |
| Site Reference ID/Investigator# 74065 | Dresden | 01067 | Germany |
| Site Reference ID/Investigator# 93513 | Dresden | 01307 | Germany |
| Site Reference ID/Investigator# 93495 | Essen | 45355 | Germany |
| Site Reference ID/Investigator# 93515 | Frankfurt | 60594 | Germany |
| Site Reference ID/Investigator# 74060 | Frankfurt | 60596 | Germany |
| Site Reference ID/Investigator# 74063 | Görlitz | 02826 | Germany |
| Site Reference ID/Investigator# 93494 | Hamburg | 22143 | Germany |
| Site Reference ID/Investigator# 93493 | Karlsruhe | 76199 | Germany |
| Site Reference ID/Investigator# 74061 | Leipzig | 04103 | Germany |
| Site Reference ID/Investigator# 74064 | Magdeburg | 39104 | Germany |
| Site Reference ID/Investigator# 93514 | Nuremberg | 90402 | Germany |
| Site reference ID/Investigator # 82515 | Barnaul | 656055 | Russia |
| Site reference ID/Investigator # 82520 | Kazan' | 420012 | Russia |
| Site reference ID/Investigator # 82493 | Kemerovo | 650002 | Russia |
| Site reference ID/Investigator # 82516 | Kemerovo | 650055 | Russia |
| Site refernce ID/Investigator # 82521 | Krasnodar | 350086 | Russia |
| Site reference ID/Investigator # 82495 | Novosibirsk | 630008 | Russia |
| Site reference ID/Investigator # 82494 | Novosibirsk | 630047 | Russia |
| Site reference ID/Investigator # 82525 | Novosibirsk | 630068 | Russia |
| Site reference ID/Investigator # 82522 | Saint Petersburg | 192283 | Russia |
| Site reference ID/Investigator # 82517 | Saint Petersburg | 194044 | Russia |
| Site reference ID/Investigator # 82524 | Saint Petersburg | 197022 | Russia |
| Site reference ID/Investiragor # 82523 | Saint Petersburg | 197022 | Russia |
| Site reference ID/Investigator # 82519 | Saint Petersburg | 198205 | Russia |
| Site reference ID/Investigator # 82518 | Saint Petersburg | 198260 | Russia |
| Site reference ID/Investigator # 82527 | Saint Petersburg | 199106 | Russia |
| Site Reference ID/Investigator# 74057 | Birmingham | B15 2SQ | United Kingdom |
| Site Reference ID/Investigator# 74059 | Cardiff | CF14 5GJ | United Kingdom |
| Site Reference ID/Investigator# 74056 | Chorley | PR7 7NA | United Kingdom |
| Site Reference ID/Investigator# 74054 | Glasgow | G20 0SP | United Kingdom |
| Site reference ID/Investigator # 95456 | Glasgow | G45 9AW | United Kingdom |
| Site Reference ID/Investigator# 74053 | Liverpool | L22 0LG | United Kingdom |
| Site reference ID/Investigator # 95457 | London | EC1M 6BQ | United Kingdom |
| Site Reference ID/Investigator# 74055 | Manchester | M16 6SX | United Kingdom |
| Site reference ID/Investigator # 95455 | Northwood | HA6 2RN | United Kingdom |
| Site Reference ID/Investigator# 74058 | Reading | RG2 0TG | United Kingdom |
| Safety Subject Sample |
|
| Full Analysis Set Population |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Full analysis set consists of 330 and 331 patients respectively.
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| ID | Title | Description |
|---|---|---|
| BG000 | Eprosartan | Eprosartan 450 mg + Placebo Eprosartan Mesylate |
| BG001 | Eprosartan Mesylate | Eprosartan Mesylate 600 mg + Placebo Eprosartan |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline | Change from baseline of diastolic blood pressure (DBP), sitting | Full analysis subject sample | Posted | Least Squares Mean | Standard Deviation | mmHg | 8 weeks |
|
|
|
15 weeks (3 run-in and 12 weeks treatment)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eprosartan | Eprosartan 450 mg + Placebo Eprosartan Mesylate | 3 | 332 | 15 | 332 | ||
| EG001 | Eprosartan Mesylate | Eprosartan Mesylate 600 mg + Placebo Eprosartan | 7 | 332 | 18 | 332 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GASTRITIS HAEMORRHAGIC | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA (15.1) | Non-systematic Assessment |
| |
| FOREARM FRACTURE | Injury, poisoning and procedural complications | MedDRA (15.1) | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| MIGRAINE | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| THYROID CYST | Endocrine disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| CYSTIC RUPTURE | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| MENISCAL DEGENERATION | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| POSTMENOPAUSAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director Clinical Services | Abbott | taco.baardman@abbott.com |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C068373 | eprosartan |
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| Male |
|