NCT03174171

Brief Summary

The overall objective is to evaluate everolimus as an aldosterone-lowering drug in the treatment of primary hyperaldosteronism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2018

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

May 24, 2017

Last Update Submit

January 8, 2019

Conditions

Primary Aldosteronism

Keywords

Everolimus, mTor inhibitor

Outcome Measures

Primary Outcomes (1)

  • Aldosterone level

    Change in aldosterone level after saline infusion test after the treatment period (Day 15) and after the washout period (Day 28) compared to baseline (Day 0).

    28 days

Secondary Outcomes (8)

  • Blood pressure values

    28 days

  • Kidney function

    28 days

  • Steroid hormones in serum

    28 days

  • Level of plasma renin activity

    28 days

  • Level of Potassium

    28 days

  • +3 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Everolimus 0.75 mg b.i.d. orally for 14 days.

Drug: Everolimus 0.75 mg

Interventions

Everolimus 0.75 mgDRUG

Everolimus 0.75 mg b.i.d. orally for 14 days.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with primary aldosteronism
  • Age ≥ 18 years
  • Office blood pressure \<160/90 mmHg on antihypertensive therapy
  • For subjects with reproductive potential, willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study

You may not qualify if:

  • Signs of current infection
  • Neutropenia (leukocyte count \< 1.5 × 109/L or absolute neutrophil count (ANC) \< 0.5 × 109/L)
  • Anemia (hemoglobin \< 11 g/dL for males, \< 10 g/dL for females)
  • Clinically significant kidney or liver disease (creatinine \> 1.5 mg/dL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2 × ULN, alkaline phosphatase \> 2 × ULN, total bilirubin \> 1.5 × ULN)
  • Current immunosuppressive treatment or documented immunodeficiency
  • Uncontrolled congestive heart failure
  • Currently pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Marc Y Donath, Prof.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2017

First Posted

June 2, 2017

Study Start

May 22, 2017

Primary Completion

June 25, 2018

Study Completion

June 25, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)