Effects Of Eplerenone On Serum Aldesterone And Plasma Renin Activity

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

To evaluate the changes in serum aldosterone and plasma renin activity on Day 0 and on Days 1 and 10 after administration of 100 mg of eplerenone daily for 10 days.

Key facts

Study ID

NCT00990223

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

20

Starts

2009-10-01

Expected to finish

2009-11-01

Last updated by the study team

2020-12-22

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if…

• Evidence or history of clinically significant disease
• Subjects with a supine BP greater than or equal to 140 mm Hg systolic or greater than or equal to 90 mm Hg diastolic or <100 mm Hg systolic and <60 mm Hg diastolic on a single measurement, as described in the protocol
• Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing
• History of sensitivity to eplerenone, spironolactone or related compounds.
• Serum potassium >5.0 mEq/L at screening or Day 0

Where it is running

• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — South Miami, Florida, United States

Full record on ClinicalTrials.gov

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