Effect of Azilsartan on Aldosterone in Postmenopausal Females

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT01774591
• Collaborator: Takeda (Industry)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Azilsartan medoximil; Drug: Placebo	N/A

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

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Azilsartan on Aldosterone in Postmenopausal Females
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: azilsartan medoximil. Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day.	Drug: Azilsartan medoximil; All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.; Other Names: Edarbi
Placebo Comparator: Placebo Subjects randomized to the placebo arm will take 80 mg of placebo tablets by mouth each day	Drug: Placebo; All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.

Outcome Measures

Primary Outcome Measures

1. 24-hour BP (Systolic) [26 weeks]

   To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.

2. 24-hour BP (Diastolic) [26 weeks]

   To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago
• Takeda

Investigators

• Principal Investigator: George Bakris, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT01774591
• Other Study ID Numbers: 12-1179
• First Posted: Jan 24, 2013
• Last Update Posted: Nov 9, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by University of Chicago: Post Menopause; Female; Obese
• Additional relevant MeSH terms: Hypertension; Azilsartan medoxomil

Study Results

Participant Flow

Arm/Group Title	Azilsartan Medoximil.	Placebo
Arm/Group Description	Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.	Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
Period Title: Overall Study
STARTED	10	11
COMPLETED	9	7
NOT COMPLETED	1	4

Baseline Characteristics

Arm/Group Title	Azilsartan Medoximil.	Placebo	Total
Arm/Group Description	Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.	Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.	Total of all reporting groups
Overall Participants	10	11	21
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	61	55	57
Sex: Female, Male (Count of Participants)
Female	10 100%	11 100%	21 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	24-hour BP (Systolic)
Description	To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.
Time Frame	26 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Azilsartan Medoximil.	Placebo
Arm/Group Description	Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.	Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
Measure Participants	10	11
Mean (Standard Deviation) [mmHg]	113 (14)	129 (904)

2. Secondary Outcome

Title	Difference in 24-hour Urine Aldosterone Change From Baseline
Description	To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on urinary aldosterone levels in postmenopausal females
Time Frame	26 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Azilsartan Medoximil.	Placebo
Arm/Group Description	Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.	Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
Measure Participants	10	11
Mean (Standard Deviation) [percentage of changes]	-47.3 (32.9)	-5.3 (52.3)

3. Primary Outcome

Title	24-hour BP (Diastolic)
Description	To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.
Time Frame	26 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Azilsartan Medoximil.	Placebo
Arm/Group Description	Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.	Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
Measure Participants	10	11
Mean (Standard Deviation) [mmHg]	75 (8.8)	89 (11)

Adverse Events

Time Frame	6 months
Arm/Group Title	Azilsartan Medoximil.		Placebo
Arm/Group Description	Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.		Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
All Cause Mortality
	Azilsartan Medoximil.		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Azilsartan Medoximil.		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Azilsartan Medoximil.		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/10 (30%)		0/11 (0%)
Hepatobiliary disorders
Hypertension	1/10 (10%)		0/11 (0%)
Skin and subcutaneous tissue disorders
Edema	1/10 (10%)		0/11 (0%)
Vascular disorders
Hypotension	1/10 (10%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.