Trial | NCT01214746  Report issue

Official Title

The Effects of Atorvastatin on the Nitric Oxide-system in Healthy Young Man

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    atorvastatin ...

  • Study Participants

    26
It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in healthy man.
Subjects will be examined on two examination days. 4 days prior to each examination day subjects are treated with either atorvastatin or placebo. During treatment periods subject are given a standardized diet.

On the examination days subject are given L-NMMA(L-NG-monomethyl Arginine citrate), a NO inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. Renal function, central hemodynamic and vasoactive hormones are evaluated prior, during and after L-NMMA infusion.

Renal function is measured by renal clearance of 51Cr-EDTA and urinary sodium, potassium and albumin concentration. Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC)will be measured to evaluate channel activity in the nephron.

Central blood pressure, pulse wave analysis, and augmentation index are measured using SphygmoCor® from Atcor.

The vasoactive hormones aldosterone, renin, angiotensin II, atrial natriuretic peptide (ANP), brain natriuretic (BNP) and endothelin is measured in plasma
Study Started
May 31
2010
Primary Completion
Jun 30
2011
Study Completion
Jun 30
2011
Last Update
Aug 16
2011
Estimate

Drug Placebo

1 tablet Unikalk 1 time pr day for 5 days

  • Other names: Unikalk

Drug Atorvastatin

Zarator, 80 mg pr day for 5 days

  • Other names: Zarator

Placebo Placebo Comparator

Atorvastatin Active Comparator

Criteria 

Inclusion Criteria:

Men and women, age 18-40 years
Body Mass Index (BMI) 18,5-30 kg/m2

Exclusion Criteria:

Arterial hypertension (>140 mmHg systolic and/or 90 mmHg diastolic)
Anamnestic or clinical signs of heart, lung, lever, kidney and brain disease
Neoplastic disease
Alcohol abuse,
Drug abuse
Medical treatment except oral anticontraceptive
Smoking
Pregnancy or
Abnormal blood and urine sample
Abnormal ECG
Blood donation within a month before examination
No Results Posted