Trial Outcomes & Findings for The Role of Mineralocorticoid Receptors in Vascular Function (NCT NCT00759525)

Last Updated: 2016-10-26

Results Overview

At the end of each 14-day intervention (Glycyrrhinitic acid or Placebo), vascular endothelial function was assessed by measuring forearm blood flow and comparing to Baseline. The outcome measure depicted below reflects the change in forearm blood flow from Baseline after completing the glycyrrhinitic acid regimen as well as the change in forearm blood flow from Baseline after taking the matching placebo.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

15 participants

Primary outcome timeframe

Outcome was measured at the end of each study period (i.e. 14 days after Baseline measurements were taken)

Results posted on

2016-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	Glycyrrhetinic Acid First, Then Placebo Glycyrrhetic Acid-130 mg/day for 14 days followed by placebo	Placebo First, Then Glycyrrhetinic Acid Placebo followed by Glycyrrhetic Acid-130 mg/day for 14 days
First Intervention (14 Days) STARTED	7	8
First Intervention (14 Days) COMPLETED	7	8
First Intervention (14 Days) NOT COMPLETED	0	0
Washout (14 Days) STARTED	7	8
Washout (14 Days) COMPLETED	7	8
Washout (14 Days) NOT COMPLETED	0	0
Second Intervention (14 Days) STARTED	7	8
Second Intervention (14 Days) COMPLETED	7	8
Second Intervention (14 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Role of Mineralocorticoid Receptors in Vascular Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=15 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	27 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Outcome was measured at the end of each study period (i.e. 14 days after Baseline measurements were taken)

Outcome measures

Outcome measures
Measure	Glycyrrhinitic Acid n=15 Participants All of the 15 subjects received both glycyrrhinitic acid (130mg/day) (GA) for a 14-day period and placebo for a 14-day period. Approximately half of the subjects received GA before placebo; the other half received placebo before GA. There was a 2-week washout period between the two conditions.	Placebo n=15 Participants All of the 15 subjects received both glycyrrhinitic acid (130mg/day) (GA) for a 14-day period and placebo for a 14-day period. Approximately half of the subjects received GA before placebo; the other half received placebo before GA. There was a 2-week washout period between the two conditions.
Forearm Blood Flow	1.87 ml/100ml of tissue/min Standard Error 0.26	1.34 ml/100ml of tissue/min Standard Error 0.20

Adverse Events

Glycyrrhetinic Acid First, Then Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo First, Then Glycyrrhetinic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark A. Creager, MD

Brigham and Women's Hospital

Phone: 617-732-5267

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place