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| Name | Class |
|---|---|
| Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | INDUSTRY |
The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ) 40/25 mg + OM/HCTZ 20/25 mg matching placebo |
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| 2 | Experimental | olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ)20/25 mg + OM/HCTZ 40/25 matching placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets | Drug | olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Trough Sitting Diastolic Blood Pressure | Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline. Change = Week 16 - Week 8 (baseline). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12 | Change = Week 12 - Week 8 (baseline). | 4 weeks |
| Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline. |
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Inclusion Criteria:
Exclusion Criteria:
Female patients of childbearing potential pregnant, lactating or planning to become pregnant during the trial period.
Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases.
Patients having a history of the following within the last six months:
Patients with clinically significant abnormal laboratory values at screening.
Patients with secondary HTN.
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| Name | Affiliation | Role |
|---|---|---|
| Professor Lars Christian Rump, M.D. | University of Ruhr-Bochum | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bruges | Belgium | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22114906 | Derived | Rosenbaum D, Girerd X. Olmesartan medoxomil combined with hydrochlorothiazide improves 24-hour blood pressure control in moderate-to-severe hypertension. Curr Med Res Opin. 2012 Feb;28(2):179-86. doi: 10.1185/03007995.2011.644626. Epub 2012 Jan 9. |
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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.
Trial is 2 week taper-off phase and 2 treatment periods. Period I - 8-week open-label OM 40mg. Only non-responders eligible to randomise into Period II. Period II - 8-week double-blind patients assigned into one of two arms. Results provided for Period II only.
92 principal investigators screened patients at clinical sites in Europe (8 in Belgium, 17 in Germany, 12 in the Netherlands, 17 in Poland, 19 in Russia, 10 in Slovakia, and 9 in the Ukraine).Sites were either hospitals or general practitioners.
First patient in: 05 December 2006 Last patient out: 07 May 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo | Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo |
| FG001 | OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg | Drug | olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks |
|
4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline).
| 8 weeks |
| Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline. | Change = Week 16 - Week 8 (baseline). | 8 weeks |
| Number of Participants Achieving Blood Pressure Goal. | 8 weeks |
| Brussels |
| Belgium |
| Drongen | Belgium |
| Godinne | Belgium |
| Mouscron | Belgium |
| Wetteren | Belgium |
| Berlin | Germany |
| Dortmund | Germany |
| Essen | Germany |
| Frankfurt | Germany |
| Goch | Germany |
| Hamburg | Germany |
| Kallstadt | Germany |
| Karlsruhe | Germany |
| Kassel | Germany |
| Magdeburg | Germany |
| Marburg | Germany |
| München | Germany |
| Wiesbaden | Germany |
| Wuppertal | Germany |
| 's-Hertogenbosch | Netherlands |
| Alphen aan den Rijn | Netherlands |
| Amsterdam-Zuidoost | Netherlands |
| Andijk | Netherlands |
| De Bilt | Netherlands |
| Ewijk | Netherlands |
| Heerlen | Netherlands |
| Hengelo | Netherlands |
| Landgraaf | Netherlands |
| Nijmegen | Netherlands |
| Oud-Beijerland | Netherlands |
| Ridderkerk | Netherlands |
| The Hague | Netherlands |
| Wildervank | Netherlands |
| Zwijndrecht | Netherlands |
| Bratislava | Slovakia |
| Levice | Slovakia |
| Lučenec | Slovakia |
| Nitra | Slovakia |
| Nové Zámky | Slovakia |
| Vráble | Slovakia |
Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo | Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo |
| BG001 | OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo | Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Mean Trough Sitting Diastolic Blood Pressure | Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline. Change = Week 16 - Week 8 (baseline). | The main analysis will be performed on the full analysis set last observation carried forward (LOCF). Pooling will be applied for small centres. | Posted | Mean | Standard Deviation | mm Hg | 8 weeks |
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| Secondary | Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12 | Change = Week 12 - Week 8 (baseline). | Posted | Mean | Standard Deviation | mm Hg | 4 weeks |
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| Secondary | Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline. | 4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline). | Posted | Mean | Standard Deviation | mm Hg | 8 weeks |
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| Secondary | Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline. | Change = Week 16 - Week 8 (baseline). | Exploratory analysis: ANCOVA was used to compare the differences in change from baseline (Visit 4, Week 8) to Week 16 (Visit 6) in daytime, nighttime and 24-hr ABPM dBP and sBP. | Posted | Mean | Standard Deviation | mm Hg | 8 weeks |
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| Secondary | Number of Participants Achieving Blood Pressure Goal. | Posted | Number | participants | 8 weeks |
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Results of Study shall not be published without prior express written consent and approval of Sponsor. If Contractor wishes to use data generated at Sites by Investigator, such data includes but not limited to data used in collection of metrics, copy of any intended publication, details of use must be sent in writing to Quintiles and Sponsor for review. Sponsor has right to change proposed publication and/or prohibit publication and Contractor must comply with requirements of Sponsor
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | 908-992-6400 | DataSharing@dsi.com |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| D006852 | Hydrochlorothiazide |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Title | Measurements |
|---|---|
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| >=65 years |
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| >= 75 years |
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| Male |
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