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Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM)

NCT02277587 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2019-04-25

No results posted yet for this study

Summary

This is a randomized, controlled, open, three-armed, multi-centre study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on anthropometric parameters, metabolic syndrome, infectious, immunological profile, cardiovascular system, bone mass and quality of life in patients affected by primary or secondary adrenal insufficiency.

Conditions

  • Primary Adrenal Insufficiency
  • Secondary Adrenal Insufficiency

Interventions

DRUG

Plenadren

Oral Tablets: 20-25-30 mg

DRUG

Conventional glucocorticoid therapy

Oral Tablets: 20-25-30- 37.5 mg

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Andrea M Isidori, MD, PhD · Dept. Experimental Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Italy

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 NCT02277587 on ClinicalTrials.gov