Stimulation of urine concentration in healthy volunteers

Phase 1

• Conditions: healthy volunteers; the information of this pilot study will be used in the care of patients with diabetes insipidus; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2016-004943-35-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-03
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

healthy volunteers >18 years old
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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

any medical history, inability to give informed consent, pregnancy, medication use

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: to determine whether sildenafil, metformin and simvastatin are effective in stimulating ADH independent urine concentration in man;Secondary Objective: not applicable;Primary end point(s): urine osmolality;Timepoint(s) of evaluation of this end point: 1 week after using one of the drugs

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): serum sodium, blood pressure, side effects;Timepoint(s) of evaluation of this end point: 1 week after using one of the drugs