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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Essential Hypertension |
| Intervention: |
Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| The trial was conducted between April 2006 and April 2008 in 9 European countries at 58 investigational sites. The countries participating were: Austria, Belgium, France, Germany, Italy, The Netherlands, Portugal, Switzerland, and United Kingdom. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
| Description | |
|---|---|
| Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed | Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. |
| Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed | |
|---|---|
| STARTED | 694 |
| COMPLETED | 601 [1] |
| NOT COMPLETED | 93 |
| Adverse Event | 21 |
| Withdrawal by Subject | 17 |
| Did not meet entry criteria | 55 |
| [1] | Some participants had multiple reasons for discontinuation |
|---|
Baseline Characteristics
| Description | |
|---|---|
| Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed | Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. |
| Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed | |
|---|---|
|
Number of Participants
[units: participants] |
694 |
|
Age
[units: years] Mean ± Standard Deviation |
58.16 ± 12.06 |
|
Gender
[units: participants] |
|
| Female | 337 |
| Male | 357 |
|
Region of Enrollment
[units: participants] |
|
| Portugal | 12 |
| France | 121 |
| Belgium | 94 |
| Austria | 35 |
| Netherlands | 43 |
| Germany | 207 |
| United Kingdom | 141 |
| Italy | 35 |
| Switzerland | 6 |
|
Weight
[units: kg] Mean ± Standard Deviation |
82.16 ± 16.09 |
|
Body Mass Index
[units: kg/m^2] Mean ± Standard Deviation |
28.86 ± 4.69 |
|
Ethnicity
[units: Participants] |
|
| Caucasian | 678 |
| Black | 13 |
| Asian | 3 |
Outcome Measures
| 1. Primary: | The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved. [ Time Frame: Baseline to ≤20 weeks ] |
| 2. Secondary: | Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved [ Time Frame: Baseline to ≤20 weeks ] |
| 3. Secondary: | Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved. [ Time Frame: Baseline to ≤20 weeks ] |
| 4. Secondary: | Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved [ Time Frame: Baseline to ≤20 weeks ] |
| 5. Secondary: | Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment [ Time Frame: Baseline to ≤20 weeks ] |
| 6. Secondary: | Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment [ Time Frame: Baseline to ≤20 weeks ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | Senior Manager - Study Coordination, Daiichi Sankyo Europe, GmbH |
| ClinicalTrials.gov Identifier: | NCT00311155 History of Changes |
| Other Study ID Numbers: | SP-OLM-03-05, 2005-004659-36 |
| Study First Received: | April 3, 2006 |
| Results First Received: | October 12, 2010 |
| Last Updated: | November 23, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |