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Stimulation of urine concentration in healthy volunteers

Stimulation of ADH independent urine concentration in healthy volunteers

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2016-004943-35-NL
Enrollment
Unknown
Registered
2017-01-03
Start date
2017-03-01
Completion date
Unknown
Last updated
2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy volunteers

Interventions

Trade Name: Sildenafil Product Name: Sildenafil Product Code: G04BE03 Pharmaceutical Form: Tablet Trade Name: Metformine Product Name: Metformine Product Code: A10BA02 Pharmaceutical Form: Tablet Tr

Sponsors

Radboud University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Netherlands

Contacts

Public ContactSecretariaat Nierziekten

Radboud University Medical Center

secretariaat.nier@radboudumc.nl0031243614761

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026