HypertensionNCT01774591
Effect of Azilsartan on Aldosterone in Postmenopausal Females
A study testing Azilsartan medoximil in people with Hypertension, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of the research is to evaluate the effect of azilsartan medoximil on blood pressure and urinary aldosterone levels in postmenopausal females. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- Azilsartan medoximil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the research is to evaluate the effect of azilsartan medoximil on blood pressure and urinary aldosterone levels in postmenopausal females.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Azilsartan medoximil, Placebo
- Keywords
- Post Menopause, Female, Obese
- Medical subject headings
- Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azilsartan medoximilDrug
Also called Edarbi
All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.
PlaceboDrug
All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.
| Study group | Role | What they receive |
|---|---|---|
| azilsartan medoximil. | Active comparator | Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day. Receives: Drug: Azilsartan medoximil |
| Placebo | Placebo comparator | Subjects randomized to the placebo arm will take 80 mg of placebo tablets by mouth each day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour BP (Systolic)
To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.
Measured: 26 weeks
24-hour BP (Diastolic)
To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.
Measured: 26 weeks
Secondary outcomes (1)
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
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- George Bakris, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774591
- Sponsor's protocol ID
- 12-1179
- Status last verified
- Oct 2017
- First submitted
- 22 Jan 2013
- Last updated
- 9 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Azilsartan on Aldosterone in Postmenopausal Females
- ClinicalTrials.gov ID
- NCT01774591
- Acronym / sponsor ID
- 12-1179
- Conditions
- Hypertension
- Keywords
- Post Menopause, Female, Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Jan 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Posted 9 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| azilsartan medoximil. | Active comparator | Drug: Azilsartan medoximilSubjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects randomized to the placebo arm will take 80 mg of placebo tablets by mouth each day |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- Male
- Diagnosed with Stage 2 hypertension
- Stage 1 hypertension requiring more than one agent
- Pregnancy or attempting pregnancy
- Use of oral contraceptive pills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azilsartan medoximilAlso: EdarbiAll subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months. | Drug | azilsartan medoximil. |
| PlaceboAll subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months. | Drug | Placebo |
Primary outcome
24-hour BP (Systolic)
Time frame: 26 weeks
To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.
24-hour BP (Diastolic)
Time frame: 26 weeks
To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.
1 secondary outcome
Difference in 24-hour Urine Aldosterone Change From Baseline
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Bakris, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azilsartan medoximil in people with Hypertension, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour BP (Systolic) (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.