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Effects of HMG-CoA-reductase inhibition (atorvastatin) on renal sodium excretion, renal hemodynamics, tubular function and vasoactive hormones in healthy subjects under diet with normal and high sodium content.

Effects of HMG-CoA-reductase inhibition (atorvastatin) on renal sodium excretion, renal hemodynamics, tubular function and vasoactive hormones in healthy subjects under diet with normal and high sodium content.

Status
Active, not recruiting
Phases
Phase 1Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-005143-28-DK
Enrollment
Unknown
Registered
2006-10-27
Start date
2006-12-06
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 volunteer trial

Interventions

Trade Name: Zarator Product Name: Atorvastatin, Zarator Pharmaceutical Form: Coated tablet Product Name: NaCl Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Capsule, hard Rout

Sponsors

Medicinsk Forskning
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Men and women, age 20-50 years, BMI=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Clinical or anamnestic signs of disease of the heart, lungs, kidney, liver, brain or endocrine organs; abnormal findings at bloodscreening (hemoglobin, sodium, potassium, albumin, creatinin, bloodsugar, bilirubin, alaninaminotransferease, basic phosphatase); albuminuri; glucose in urine; cancer, hypertension, addiction to alcohol; medical treatment except per oral anticonception; pregnancy or breastfeeding; blooddonation one month before the trail.

Design outcomes

Primary

MeasureTime frame
Main Objective: Investigate the effect of atorvastatin on renal haemodynamics, renal tubular function, vasoactive hormones, bloodpressure and heartrate in healthy humans.;Secondary Objective: Analyse if changes in renal haemodynamics, renal tubular function, vasoactive hormones, bloodpressure and heartrate under treatment with atorvastatin depends on saltcontent in diet in healthy humans.;Primary end point(s): Changes in glomerular filtration rate, clearance of sodium and lithium, fractional excretion of sodium and lithium, urin koncentration of aquapurin-2, total sodium excretion and free water clearance. Changes in koncentration of vasopressin, angiotensin II, aldosterone, atrial- and brain natriuric peptide, renin, bloodpressure and heartrate.—

Countries

Denmark

Outcome results

None listed

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