Working… Menu
Trial record 14 of 112 for:    EPLERENONE

Effects Of Eplerenone On Serum Aldesterone And Plasma Renin Activity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00990223
Recruitment Status : Completed
First Posted : October 6, 2009
Last Update Posted : February 17, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Eplerenone or Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Official Title: A Phase 1, Double-Blind (Sponsor Open), Randomized, Placebo-Controlled Trial To Evaluate The Effects Of 100 MG Once Daily Of Eplerenone On Serum Aldesterone And Plasma Renin Activity During 10 Days Of Dosing In Healthy Volunteers
Study Start Date : October 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Arm Intervention/treatment
Experimental: Cohort 1
Healthy Volunteers - eplerenone versus placebo.
Drug: Eplerenone or Placebo
Eplerenone 100 mg or Placebo, daily for 10 days.

Primary Outcome Measures :
  1. Area under the effect curve (AUEC) for serum aldosterone and PRA on Day 0 and on Days 1 and 10 after administration of 100 mg of eplerenone [ Time Frame: 11 days ]

Secondary Outcome Measures :
  1. Single Dose PK for eplerenone: Cmax, Tmax, and AUCtau; Multiple Dose PK for eplerenone: Cmax(ss), Tmax(ss), AUC(,tau,ss), half life, Cmin(ss), Cave(ss), accumulation ratios AUC(tau,ss)/AUC(tau,sd) and Cmax(ss)/Cmax(sd). [ Time Frame: 13 days ]
  2. Safety and tolerability of eplerenone as determined by adverse event reporting, clinical laboratory results, vital signs (supine blood pressure and heart rate), physical examinations and ECGs. [ Time Frame: 13 days ]
  3. Change from baseline (Day 0) to Day 8 in exploratory mRNA gene expression biomarkers (SGK1: Serum/glucocorticoid regulated kinase 1 gene, ENaCα: Epithelial Sodium Channel alpha subunit, ENaCγ: Epithelial Sodium Channel gamma subunit, [ Time Frame: 9 days ]
  4. MR: Mineralcorticoid Receptor, ACTβ: Beta Actin) after administration of eplerenone or placebo. These results will not be included in the study report. [ Time Frame: 9 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00990223

Layout table for location information
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33143
Pfizer Investigational Site
South Miami, Florida, United States, 33143
Sponsors and Collaborators
Layout table for investigator information
Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00990223     History of Changes
Other Study ID Numbers: A6141115
First Posted: October 6, 2009    Key Record Dates
Last Update Posted: February 17, 2011
Last Verified: February 2011
Keywords provided by Pfizer:
Eplerenone Aldosterone and Plasma Renin Activity responses Pharmacodynamics
Additional relevant MeSH terms:
Layout table for MeSH terms
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Antihypertensive Agents