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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003131-23 EudraCT number |
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This study will analyse the dose-dependent effect of olmesartan medoxomil on the change in arterial stiffness in subjects with hypertension and metabolic syndrome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | A 3-week placebo run-in period. |
|
| 2 | Experimental | Olmesartan medoxomil oral tablets, at lowest study dosage for 52-week double-blind treatment period |
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| 3 | Experimental | Olmesartan medoxomil oral tablets at the lowest dosage for 4 weeks followed by a higher dosage for 48 weeks. |
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| 4 | Experimental | Olmesartan medoxomil oral tablets at the lowest dosage for 4 weeks followed by a higher dosage for 4 weeks followed by the highest study dose for 44 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olmesartan medoxomil | Drug | dosage form: oral tablet; frequency: daily; duration: 52 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in carotid-femoral pulse wave velocity (PWV) | Up to 1 year of double-blind treatment | |
| The change from baseline in carotid-femoral PWV, after adjustment for change from baseline in mean blood pressure (MBP)as measured at the same visit | Up to 1 year of double-blind treatment |
| Measure | Description | Time Frame |
|---|---|---|
| On blood pressure (BP) lowering, assessed by conventional BP measurement and 24h ambulatory BP measurement (24h-ABPM) | Up to 1 year of double-blind treatment | |
| On central pulse pressure (PP) and augmentation index (AI) | Up to 1 year of double-blind treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent | Belgium | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25001274 | Derived | Laurent S, Boutouyrie P; Vascular Mechanism Collaboration. Dose-dependent arterial destiffening and inward remodeling after olmesartan in hypertensives with metabolic syndrome. Hypertension. 2014 Oct;64(4):709-16. doi: 10.1161/HYPERTENSIONAHA.114.03282. Epub 2014 Jul 7. |
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De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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| placebo |
| Drug |
dosage form: tablet; frequency: daily; duration: 3 weeks |
|
| olmesartan medoxomil | Drug | dosage form: oral tablet; frequency: daily; duration: 52 weeks |
|
| olmesartan medoxomil | Drug | dosage form: oral tablet; frequency: daily; duration: 52 weeks |
|
| On common carotid stiffness, intima-media thickness (IMT), and internal diameter | Up to 1 year of double-blind treatment |
| Nuremberg |
| Germany |
| Monza | Italy |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
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