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Effects Of Eplerenone On Serum Aldesterone And Plasma Renin Activity

Last updated on December 16, 2017

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Study Location
Pfizer Investigational Site
Miami, Florida, 33143 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 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

NCT00990223
Pfizer
Completed
Effects Of Eplerenone On Serum Aldesterone And Plasma Renin Activity

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Effects Of Eplerenone On Serum Aldesterone And Plasma Renin Activity
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Healthy Volunteers
Drug: Eplerenone or Placebo
Eplerenone 100 mg or Placebo, daily for 10 days.
Experimental: Cohort 1
Healthy Volunteers - eplerenone versus placebo.
Intervention: Drug: Eplerenone or Placebo
Eudy RJ, Sahasrabudhe V, Sweeney K, Tugnait M, King-Ahmad A, Near K, Loria P, Banker ME, Piotrowski DW, Boustany-Kari CM. The use of plasma aldosterone and urinary sodium to potassium ratio as translatable quantitative biomarkers of mineralocorticoid receptor antagonism. J Transl Med. 2011 Oct 21;9:180. doi: 10.1186/1479-5876-9-180.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2009
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00990223
A6141115
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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