Effects Of Eplerenone On Serum Aldesterone And Plasma Renin Activity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

Healthy Volunteers - eplerenone versus placebo.

Group Type EXPERIMENTAL

Eplerenone or Placebo

Intervention Type DRUG

Eplerenone 100 mg or Placebo, daily for 10 days.

Interventions

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Eplerenone or Placebo

Eplerenone 100 mg or Placebo, daily for 10 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes