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| Name | Class |
|---|---|
| Daiichi Sankyo Taiwan Ltd. | INDUSTRY |
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The purpose of this study is to determine the efficacy and safety of oral administration of olmesartan medoxomil compared to losartan in subjects with mild to moderate hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | olmesartan medoxomil |
|
| 2 | Active Comparator | losartan potassium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olmesartan medoxomil | Drug | olmesartan medoxomil oral tablets, once daily for up to 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change of Sitting dBP From Baseline to Week 12 | The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12. | Baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Hospital | Kaohsiung City | Taiwan | ||||
| Chung Shun Medical University Hospital |
After a taper off period for 1 week, if necessary, and a placebo run-in period for 2 weeks, 130 subjects were randomized to olmesartan 20mg and losartan 50mg by 1:1 ratio.
A total of 181 subjects were screened at 3 study sites in Taiwan from May 2002 to April 2003, and 51 subjects had dropped as screen failure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olmesartan Medoxomil | olmesartan medoxomil oral tablets, once daily for up to 12 weeks |
| FG001 | Losartan Potassium | losartan potassium oral tablets, once daily for up to 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Olmesartan Medoxomil | olmesartan medoxomil oral tablets, once daily for up to 12 weeks |
| BG001 | Losartan Potassium | losartan potassium oral tablets, once daily for up to 12 weeks |
| 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 | Mean Change of Sitting dBP From Baseline to Week 12 | The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12. | Four randomized subjects (3 in olmesartan, 1 in losartan) were excluded from the analysis due to a lack of post-treatment efficacy evaluation. | Posted | Mean | Standard Error | mmHg | Baseline to 12 weeks |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Regulatory Operations | Daiichi Sankyo, Inc. | 732-590-5000 | hmkessler@dsus.com |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| losartan potassium |
| Drug |
losartan oral tablets, once daily for up to 12 weeks |
|
| Taichung |
| Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Randomization criteria not met |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
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| D013777 |
| Tetrazoles |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |