Macrolides for KCNJ5 - Mutated Aldosterone-Producing Adenoma (MAPA)

NCT03414918 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2018-01-30

No results posted yet for this study

Summary

This study evaluates if :

1 ) the plasma aldosterone concentration and blood pressure change in response to roxithromycin could be useful for the screening of PA patients carrying a KCNJ5-mutated APA; 2) the change of PAC in response to mutated KCNJ5 channel is truly occurring in KCNJ5-mutated APA.

Conditions

  • Hyperaldosteronism

Interventions

DRUG

Clarithromycin

Hypertensive patients will be exposed to a single oral dose of 150 mg of roxithromycin. A 150-mg oral dose of roxithromycin should yield peak plasma concentrations of 5-12 mcg/mL14, which are higher than the IC50 measured in vitro (0.18-0.53 mcg/mL).

Sponsors & Collaborators

  • DMG Paris Descartes

    collaborator OTHER
  • University Hospital Padova

    lead OTHER

Principal Investigators

  • Gian Paolo Rossi, MD · University of Padova

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-03-31
Primary Completion
2019-01-31
Completion
2020-01-31

Countries

  • Italy

Study Locations

More Related Trials

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 NCT03414918 on ClinicalTrials.gov