Hypertension
Conditions
Keywords
Post Menopause, Female, Obese
Brief summary
The purpose of the research is to evaluate the effect of azilsartan medoximil on blood pressure and urinary aldosterone levels in postmenopausal females.
Detailed description
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.
Interventions
DRUGAzilsartan medoximil
All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.
DRUGPlacebo
All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.
Sponsors
Takeda
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Female * Ages 45-70 * Post-menopause: have not had a menstrual period for one year or more * Diagnosed with Stage 1 hypertension * Body Mass Index (BMI) greater than or equal to 28
Exclusion criteria
* Male * Diagnosed with Stage 2 hypertension * Stage 1 hypertension requiring more than one agent * Pregnancy or attempting pregnancy * Use of oral contraceptive pills * Use of hormone replacement therapy * Use of steroids * Stage 3 or greater kidney disease * Diabetes mellitus * untreated hypothyroidism or hyperthyroidism * primary hyperaldosteronism * Cushing's disease * obstructive sleep apnea * chronic illness, e.g. chronic liver disease * NYHA class III or greater heart failure * moderate to severe lung disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour BP (Systolic) | 26 weeks | To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females. |
| 24-hour BP (Diastolic) | 26 weeks | To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in 24-hour Urine Aldosterone Change From Baseline | 26 weeks | To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on urinary aldosterone levels in postmenopausal females |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Placebo Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months. | 11 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Azilsartan Medoximil. | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 61 years | 55 years | 57 years |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 11 |
Outcome results
Primary
24-hour BP (Diastolic)
To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.
Time frame: 26 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoximil. | 24-hour BP (Diastolic) | 75 mmHg | Standard Deviation 8.8 |
| Placebo | 24-hour BP (Diastolic) | 89 mmHg | Standard Deviation 11 |
Primary
24-hour BP (Systolic)
To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.
Time frame: 26 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoximil. | 24-hour BP (Systolic) | 113 mmHg | Standard Deviation 14 |
| Placebo | 24-hour BP (Systolic) | 129 mmHg | Standard Deviation 904 |
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
Time frame: 26 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoximil. | Difference in 24-hour Urine Aldosterone Change From Baseline | -47.3 percentage of changes | Standard Deviation 32.9 |
| Placebo | Difference in 24-hour Urine Aldosterone Change From Baseline | -5.3 percentage of changes | Standard Deviation 52.3 |