Phase 4 Completed N=20 Randomized Triple-blind Basic Science

Diurnal Variation of Plasminogen Activator Inhibitor-1

Metabolic Syndrome X

Source: ClinicalTrials.gov NCT00515021 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcomePrimary: Plasminogen Activator Inhibitor-1 (PAI-1) Levels — 41.5; 42.9 ng/ml

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Plasminogen Activator Inhibitor-1 (PAI-1) Levels	39.9; 40.4	—

Eligibility Criteria

Inclusion Criteria

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 150 mg/dl)

Exclusion Criteria

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 5.5 mEq/L
Reported hypersensitivity to HCTZ or eplerenone

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00515021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.