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The purpose of the study is to test the efficacy and safety of the combination of Calcium Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class) and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not adequately controlled with olmesartan medoxomil alone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | olmesartan medoxomil tablets and a CCB tablet (of the dihydropyridine class), once daily for 8 weeks |
|
| 2 | Experimental | olmesartan medoxomil and a diuretic tablet (of the thiazide class) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olmesartan medoxomil and a CCB | Drug | olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85 | Baseline to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings) | Drug-related adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Research and Development Division | Daiichi Sankyo Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
After the 4 to 6 weeks of olmesartan medoxomil monotherapy period, 105 patients who met the entry criteria for the combination therapy period were randomized to calcium channel blocker (of the dihydropyridine class) combination group or diuretic (of the thiazide class)combination group.
A total of 172 patients were enrolled at 5 centers in Japan from February 12, 2005 to April 30, 2005.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olmesartan Tablets and a Calcium Channel Blocker Tablet | olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks |
| FG001 | Olmesartan Medoxomil Tablets and a Diuretic Tablet | olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class)once daily for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Olmesartan Tablets and a Calcium Channel Blocker Tablet | olmesartan medoxomil tablets and a calcium channel blocker tablet, once daily for 8 weeks |
| BG001 | Olmesartan Medoxomil Tablets and a Diuretic |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85 | Primary analysis was conducted for full analysis set. It excluded the patients who were not administrated study drugs, or did not satisfy entry criteria, or had no data after randomisation. | Posted | Number | Percent of participants | Baseline to week 8 |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard Kessler | Daiichi Sankyo | 732-590-5032 | hmkessler@dsi.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| 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 |
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| olmesartan medoxomil and a diuretic | Drug | olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks |
|
| At week 8 |
| Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values) | Drug-related, laboratory value change adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence. | At week 8 |
| Other |
|
| Withdrawal by Subject |
|
olmesartan medoxomil tablets and a diuretic once daily for 8 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings) | Drug-related adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence. | Safety analysis (Clinical AEs:subjective symptoms / objective findings) was conducted for Safety Population. It excluded the patients who were not administrated study drugs. | Posted | Number | Percent of participants | At week 8 |
|
|
|
|
| Secondary | Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values) | Drug-related, laboratory value change adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence. | Safety analysis (laboratory AEs:abnormal changes in clinical laboratory values) was conducted for Safety Population. It excluded the patients who were not administered study drugs, or had no clinical laboratory data. | Posted | Number | Percent of participants | At week 8 |
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| D013777 |
| Tetrazoles |