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In patients naive to treatment or after a 2-week washout period for patients whose treatment was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme: monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary | Drug | olmesartan medoxomil tablets,or olmesartan medoxomil/hydrochlorothiazide tablets, if necessary + amlodipine tablets, if necessary. All interventions are once-daily for 4 to 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy) | Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level | 4 - 9 wks of olmesartan monotherapy |
| 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) | 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)If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks | 4 to 9 weeks on combination therapy |
| Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide) | Number of patients that achieved a blood pressure goal of less than 130/85 in second titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks. | 4 to 9 weeks |
| Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine) | Number of patients that achieved a blood pressure goal of less than 130/85 in third titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide + amlodipine 5 mg). This combination was maintained as long as the participant's blood pressure remained within predefined parameters. If not, participant discontinued for lack of efficacy. | 4 - 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olmesartan + Hydrochlorothiazide + Amlodipine |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Olmesartan + Hydrochlorothiazide + Amlodipine |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy) | Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level | In this first dosage group 144 started and 38 patients met their blood pressure goal; therefore, 106 started the first titration regimen. There were no dropouts. | Posted | Number | Participants | 4 - 9 wks of olmesartan monotherapy |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard Kessler | Daiichi Sankyo Pharma Development | 732-590-5032 | hmkessler@dsus.com |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| D006852 | Hydrochlorothiazide |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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) | 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)If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks | In this first titration group 106 patients started and 33 achieved their blood pressure goal. There were no dropouts and 73 subject started the second titration regimen. | Posted | Number | Participants | 4 to 9 weeks on combination therapy |
|
|
|
| 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) | Number of patients that achieved a blood pressure goal of less than 130/85 in second titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks. | 73 patients started the second titration regimen and 41 met their blood pressure goal. There were no dropouts. 32 started the final titration regimen. | Posted | Number | Participants | 4 to 9 weeks |
|
|
|
| Primary | Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine) | Number of patients that achieved a blood pressure goal of less than 130/85 in third titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide + amlodipine 5 mg). This combination was maintained as long as the participant's blood pressure remained within predefined parameters. If not, participant discontinued for lack of efficacy. | 32 subjects started the third and final titration regimen and 12 met their blood pressure goals. 20 dropped out for lack of efficacy. | Posted | Number | Participants | 4 - 9 weeks |
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| 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 |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |