NCT00515021

Brief Summary

To determine if nighttime administration of an aldosterone antagonist would effectively lower peak plasma Plasminogen Activator Inhibitor-1 (PAI-1) levels more effectively than morning administration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
8.8 years until next milestone

Results Posted

Study results publicly available

February 1, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

August 9, 2007

Results QC Date

March 16, 2017

Last Update Submit

January 31, 2019

Conditions

Metabolic Syndrome X

Keywords

Metabolic syndromeAldosterone inhibitorDiurnal drug regimenPAI-1 levels

Outcome Measures

Primary Outcomes (2)

  • Plasminogen Activator Inhibitor-1 (PAI-1) Levels

    baseline PAI-1 levels prior to drug administration

    Baseline

  • Plasminogen Activator Inhibitor-1 (PAI-1) Levels

    PAI-1 levels after Eplerenone 50mg daily for 2 weeks then 100mg daily for 4 weeks. Time of administration varied in the arms, either morning or night time dosing.

    after 6 weeks on Eplerenone

Study Arms (2)

Daytime then nightime dosing

EXPERIMENTAL

Eplerenone - 50mg, by mouth, daily, in the morning x 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks then patients cross over to 50mg, by mouth, daily, in the evening x 2 weeks followed by 100mg, by mouth, daily, in the evening x 4 weeks.

Drug: Eplerenone (Morning)Drug: Eplerenone (Night-time)

Nighttime then daytime dosing

EXPERIMENTAL

Eplerenone - 50mg, by mouth, daily, in the evening x 2 weeks followed by 100mg, by mouth, daily, in the evening x 4 weeks then patients cross over to 50mg, by mouth, daily, in the morning x 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks.

Drug: Eplerenone (Morning)Drug: Eplerenone (Night-time)

Interventions

Eplerenone (Morning)DRUG

Eplerenone - 50mg, by mouth, daily, in the morning x 2 weeks followed by 4 weeks at 100mg. 100mg, by mouth, daily, in the morning x 4 weeks then patients cross over to 100mg, by mouth, daily, in the evening x another 4 weeks.

Also known as: Inspra
Daytime then nightime dosingNighttime then daytime dosing
Eplerenone (Night-time)DRUG

Eplerenone - 50mg, by mouth, daily in the evening x 2 weeks followed by 4 weeks at 100mg

Also known as: Inspra
Daytime then nightime dosingNighttime then daytime dosing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age18-65
  • Metabolic Syndrome (3 or more of the following):
  • Blood pressure 130/85 or greater
  • Central obesity (Waist - Male \> 40", Female \> 35")
  • Fasting glucose ≥ 110 mg/dl
  • Low HDL (Male \< 40 mg/dl, Female \< 50 mg/dl)
  • Elevated Triglycerides (\> 150 mg/dl)

You may not qualify if:

  • Cigarette Use
  • Renal insufficiency
  • Coronary Artery Disease
  • Diabetes
  • Blindness
  • Cerebrovascular Disease
  • Secondary hypertension (renal artery stenosis, pheo, etc.)
  • RAAS disease (Primary Aldosteronism, etc.)
  • Other chronic illness (cancer, autoimmune or liver disease)
  • Pregnancy
  • Anemia (Hgb \< 12 mg/dl)
  • Evening or Night Shift work
  • Transmeridian travel in previous 6 months
  • History of sleep disorders
  • Hypokalemia (serum potassium \< 3.5 milliequivalent (mEq/L)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-8802, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
James Muldowney
Organization
Vanderbilt University Medical Center
james.muldowney@vanderbilt.edu
615-936-1720

Study Officials

  • James A Muldowney, III, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 9, 2007

First Posted

August 13, 2007

Study Start

April 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

February 1, 2019

Results First Posted

February 1, 2019

Record last verified: 2019-01

Locations

US(1)