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Effect of Statin Use on Aldosterone Secretion

NCT02871687 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2022-09-29

No results posted yet for this study

Summary

The purpose of this research protocol is to determine if the same effects are observed in vivo in humans through a randomized controlled study. Data regarding a novel mechanism of the widely used statin class of medications on the mineralocorticoid pathway would likely have significant clinical implications on the future management of hypertension and other cardiovascular disease given the known pleiotropy of aldosterone action.

Conditions

  • Healthy Subjects

Interventions

DRUG

Simvastatin

Simvastatin 20 mg daily followed by potential increase to 40 mg simvastatin according to dose escalation procedure

DRUG

Pravastatin

Pravastatin 40 mg daily followed by potential increase to 80 mg pravastatin according to dose escalation procedure

OTHER

Placebo

Placebo prepared by Investigation Drug Services at Brigham and Women's Hospital

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Jonathan Williams, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02871687 on ClinicalTrials.gov