Treatment of congenital nephrogenic diabetes insipidus with riociguat or sildenafil

Phase 1

• Conditions: ephrogenic diabetes insipidus because of AVP2R-mutation; MedDRA version: 20.0 Level: LLT Classification code 10012626 Term: Diabetes nephrogenic (excludes glycosuria) System Organ Class: 100000004857; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2016-001591-30-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-09
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 2

Inclusion Criteria

Age > 18 year
- Mentally capable of understanding the test
- Nephrogenic diabetes insipidus
- Followed at the Odense University Hospital
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Other known relevant disease including malignity
- Contraindications to riociguat or sildenafil (e.g. treatment with nitrovasodilators).
- Systolic blood pressure < 95mmHg

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified