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| Study Type: | Interventional |
|---|---|
| Study Design: | Control: Uncontrolled, 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 study pop. was defined by the inclusion criteria. This study was carried out in 14 centers in Brazil with inclusion 2 months after the first study subject, started in Aug 06. After the screening visit, the patients that met inclusion and exclusion criteria were selected to participate in the study. The last patient out was in Jul 07. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| A wash out period was needed in case of a previous inefficient antihypertensive medication, so it was interrupted from 2 to 3 wks before the enrollment. The patient could be excluded considering the exclusion criteria. |
| Description | |
|---|---|
| Olmesartan + Hydrochlorothiazide + Amlodipine |
|
| Olmesartan + Hydrochlorothiazide + Amlodipine | |
|---|---|
| STARTED | 144 |
| COMPLETED | 124 |
| NOT COMPLETED | 20 |
| Lack of Efficacy | 20 |
Baseline Characteristics
| Description | |
|---|---|
| Olmesartan + Hydrochlorothiazide + Amlodipine |
|
| Olmesartan + Hydrochlorothiazide + Amlodipine | |
|---|---|
|
Number of Participants [units: participants] |
144 |
|
Age [units: participants] |
|
| <=18 years | 0 |
| Between 18 and 65 years | 132 |
| >=65 years | 12 |
|
Gender [units: participants] |
|
| Female | 74 |
| Male | 70 |
|
Race/Ethnicity, Customized [units: Participants] |
|
| Black | 24 |
| White | 83 |
| Asian | 7 |
| Other | 30 |
|
Region of Enrollment [units: participants] |
|
| Brazil | 144 |
Outcome Measures
| 1. Primary: | Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy) [ Time Frame: 4 - 9 wks of olmesartan monotherapy ] |
| 2. Primary: | Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide) [ Time Frame: 4 to 9 weeks on combination therapy ] |
| 3. Primary: | Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide) [ Time Frame: 4 to 9 weeks ] |
| 4. Primary: | Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine) [ Time Frame: 4 - 9 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: | Daiichi Sankyo Brazil ( Medical Affairs Manager ) |
| Study ID Numbers: | SPB-OM-0106 |
| Study First Received: | February 11, 2009 |
| Results First Received: | February 11, 2009 |
| Last Updated: | May 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00890591 History of Changes |
| Health Authority: | Brazil: Ethics Committee |