Is augmentation of PORH by rosuvastatin adenosine-receptor mediated? - rosucaf2

• Conditions: mechanism of influence of statins on human adaptive mechanisms in hypoxic circumstances; MedDRA version: 9.1Level: LLTClassification code 10021143Term: Hypoxia

• Registration Number: EUCTR2008-005985-30-NL
• Lead Sponsor: Department of Pharmacology-Toxicology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

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

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.

Study & Design

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