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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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The purpose of the research is to evaluate the effect of azilsartan medoximil on blood pressure and urinary aldosterone levels in postmenopausal females.
The study is a randomized, placebo-controlled trial of post-menopausal females with stage 1 hypertension. The goal is to randomize 40 post-menopausal females with stage 1 hypertension and assess whether azilsartan reduces urinary aldosterone levels. We will compare subjects having azilsartan medoximil (treatment group) with placebo group. Additionally, a small sub-study comparing pre-menopausal and post-menopausal female aldosterone levels was performed as well as the presence of aldosterone production in fat cell cultures of a subset of 3 patients in the randomized trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| azilsartan medoximil. | Active Comparator | Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day. |
|
| Placebo | Placebo Comparator | Subjects randomized to the placebo arm will take 80 mg of placebo tablets by mouth each day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azilsartan medoximil | Drug | All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour BP (Systolic) | To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females. | 26 weeks |
| 24-hour BP (Diastolic) | To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in 24-hour Urine Aldosterone Change From Baseline | To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on urinary aldosterone levels in postmenopausal females | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Bakris, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Azilsartan Medoximil. | Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months. |
| FG001 | Placebo | Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Azilsartan Medoximil. | Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 24-hour BP (Systolic) | To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females. | Posted | Mean | Standard Deviation | mmHg | 26 weeks |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azilsartan Medoximil. | Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George L. Bakris, MD | University of Chicago | 773-702-7936 | bbrisky@medicine.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| C521273 | azilsartan |
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|
| Placebo | Drug | All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months. |
|
| Adverse Event |
|
Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Difference in 24-hour Urine Aldosterone Change From Baseline | To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on urinary aldosterone levels in postmenopausal females | Posted | Mean | Standard Deviation | percentage of changes | 26 weeks |
|
|
|
| Primary | 24-hour BP (Diastolic) | To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females. | Posted | Mean | Standard Deviation | mmHg | 26 weeks |
|
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | Placebo | Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months. | 0 | 11 | 0 | 11 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypertension | Hepatobiliary disorders | Systematic Assessment |
|
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| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |