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Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism

NCT02525796 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2023-05-03

Study results available
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Summary

This study will evaluate whether blocking the mineralocorticoid receptor, alone, or in combination with the calcimimetic cinacalcet, can lower parathyroid hormone and calcium levels in primary hyperparathyroidism.

Conditions

  • Primary Hyperparathyroidism

Interventions

DRUG

eplerenone

eplerenone, titrated up to a maximum of 50mg BID

DRUG

amiloride

amiloride, titrated up to a maximum of 10mg BID

DRUG

Placebo

DRUG

Cinacalcet

Cinacalcet, as add-on therapy in addition to eplerenone/amiloride/placebo, titrated up to a maximum of 30mg BID

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Anand Vaidya, MD MMSc · Brigham and Women's Hospital, Harvard Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2021-10-01
Completion
2021-10-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02525796 on ClinicalTrials.gov