Trial Outcomes & Findings for Effect of Azilsartan on Aldosterone in Postmenopausal Females (NCT NCT01774591)

NCT ID: NCT01774591

Last Updated: 2017-11-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 26 weeks
• Results posted on: 2017-11-09

Participant Flow

Participant milestones

Measure	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.	Placebo Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
Overall Study STARTED	10	11
Overall Study COMPLETED	9	7
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Measure	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.	Placebo Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
Overall Study Physician Decision	1	1
Overall Study Withdrawal by Subject	0	1
Overall Study Adverse Event	0	2

Baseline Characteristics

Effect of Azilsartan on Aldosterone in Postmenopausal Females

Baseline characteristics by cohort

Measure	Azilsartan Medoximil. n=10 Participants Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.	Placebo n=11 Participants Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.	Total n=21 Participants Total of all reporting groups
Age, Continuous	61 years n=5 Participants	55 years n=7 Participants	57 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 26 weeks

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

Outcome measures

Measure	Azilsartan Medoximil. n=10 Participants Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.	Placebo n=11 Participants Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
24-hour BP (Systolic)	113 mmHg Standard Deviation 14	129 mmHg Standard Deviation 904

PRIMARY outcome

Timeframe: 26 weeks

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

Outcome measures

Measure	Azilsartan Medoximil. n=10 Participants Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.	Placebo n=11 Participants Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
24-hour BP (Diastolic)	75 mmHg Standard Deviation 8.8	89 mmHg Standard Deviation 11

SECONDARY outcome

Timeframe: 26 weeks

To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on urinary aldosterone levels in postmenopausal females

Outcome measures

Measure	Azilsartan Medoximil. n=10 Participants Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.	Placebo n=11 Participants Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
Difference in 24-hour Urine Aldosterone Change From Baseline	-47.3 percentage of changes Standard Deviation 32.9	-5.3 percentage of changes Standard Deviation 52.3

Adverse Events

Azilsartan Medoximil.

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Azilsartan Medoximil. n=10 participants at risk Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day and followed for six months.	Placebo n=11 participants at risk Subjects randomized to the placebo arm took 80 mg of placebo tablets by mouth each day and followed for six months.
Vascular disorders Hypotension	10.0% 1/10 • 6 months	0.00% 0/11 • 6 months
Skin and subcutaneous tissue disorders Edema	10.0% 1/10 • 6 months	0.00% 0/11 • 6 months
Hepatobiliary disorders Hypertension	10.0% 1/10 • 6 months	0.00% 0/11 • 6 months

Additional Information

George L. Bakris, MD

University of Chicago

Phone: 773-702-7936

Email: bbrisky@medicine.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place