Open-label Study on Treatment of Primary Aldosteronism With Everolimus

• Status: Completed
• Trial end date: 2018-06-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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