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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
The purpose of this study is to assess the efficacy and safety of Irbesartan 150/12.5 mg and 300/25 mg in patients with hypertension not controlled by monotherapy.
The primary and secondary endpoints applied to sub-groups defined by age, race, diabetes, metabolic syndrome and prior HTN therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRBESARTAN | Drug | 150/12.5 mg tablets one or two tablets orally per day |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the mean SBP | from baseline to week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean DBP | from baseline to week 18. | |
| Changes in mean SBP and DBP | from baseline to week 10 | |
| SBP and DBP response and control rates |
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Inclusion Criteria:
Note: Female patients must be post-menopausal for one year, surgically sterilized, or using a medically accepted method of contraception (intrauterine device, oral contraceptives, barrier method with spermicide) and must agree to use an effective method of contraception throughout the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Mooney | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Bridgewater | New Jersey | 08807 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| at weeks 10 and 18 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |