Status:
COMPLETED
Effects Of Eplerenone On Serum Aldesterone And Plasma Renin Activity
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00990223
Start Date
October 1 2009
End Date
November 1 2009
Last Update
December 22 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Miami, Florida, United States, 33143
2
Pfizer Investigational Site
South Miami, Florida, United States, 33143