mechanism of influence of statins on human adaptive mechanisms in hypoxic circumstances MedDRA version: 9.1 Level: LLT Classification code 10021143 Term: Hypoxia
Conditions
Interventions
Trade Name: Crestor
Pharmaceutical Form: Tablet
INN or Proposed INN: Rosuvastatine
CAS Number: 287714-41-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Trad
Sponsors
Department of Pharmacology-Toxicology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers, 18-50 years of age 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of any cardiovascular disease Hypertension (in supine position: systole >140 mmHg, diastole >90 mmHg) Diabetes Mellitus (fasting glucose >7.0 mmol/L or random glucose >11.0 mmol/L) Hyperlipidemia (fasting total cholesterol >5.5 mmol/L or random cholesterol >6.5 mmol/L) Alanine amino transferase >90 U/L Creatin kinase >440 U/L Raised rabdomyolysis risk: - GFR <80 ml/min - overt clinical signs of hypothyroidism - Myopathy in family history - Alcohol abuse Concomitant chronic use of medication Participation to any drug-investigation during the previous 60 days as checked with VIP check according to CRCN standard procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the influence of caffeine on post occlusive reactive hyperaemia before and after 7 days treatment with rosuvastatin 20mg once daily;Secondary Objective: ;Primary end point(s): forearm bloodflow measured after 3, 5 and 13 minutes of forearm ischemia (post occlussive reactive hyperaemia (PORH)) | — |
Countries
Netherlands
Outcome results
None listed