Macrolides for KCNJ5 - Mutated Aldosterone-Producing Adenoma (MAPA)
NCT03414918 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 342
Last updated 2018-01-30
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
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