The study is designed to test the hypothesis in healthy subjects that candesartan and pioglitazone provide additional vascular relaxing or modulating effects in addition to their blood-pressure and blood glucose level reducing ability, respectively.

Condition	Intervention
Healthy subjects	Drug: Pioglitazone (drug) and/or candesartan (drug)

Further Study Details: 

Primary Outcomes: Vascular reactivity
Secondary Outcomes: Pulse wave velocity; Changes in Angiotensin metabolites
Expected Total Enrollment:  40

The aim of the study is to investigate the effect of oral candesartan and/ or rosiglitazone therapy on the vascular responsiveness of different vasoactive compounds (angiotensin II, insulin, histamine and glyceroltrinitrate) in healthy subjects. Pioglitazone will be given orally (4 weeks 30mg/d, titrated to 45 mg/d for another 4 weeks). Candesartan will be given orally (4 weeks 8mg/d, titrated to 16 mg/d for another 4 weeks) as treatment. Every subject will receive intravenous stimulation with phenylephrine, angiotensin II, histamine, insulin and glyceroltrinitrate before and after an 8 weeks treatment interval with study medication or placebo. In addition, pulse wave velocity will me measured non-invasively before and after treatment.

Ages Eligible for Study:  18 Years   -   40 Years,  Genders Eligible for Study:  Male

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Male
• healthy
• 18 - 40 years old
• non-smoker
• no additional medication

Exclusion Criteria:

• any relevant disease
• smokers
• elevated liver enzymes
• body weight different from Broca Norm > 20%
• allergies

Please refer to this study by ClinicalTrials.gov identifier  NCT00154037

Christoph Schindler, MD      +493514582027    christoph.schindler@tu-dresden.de

Germany
      Institute of Clinical Pharmacology, Medical Faculty, University of Technology, Dresden,  01307,  Germany

Study chairs or principal investigators

Wilhelm Kirch, MD,  Study Chair,  Institute of Clinical Pharmacology   

Study ID Numbers:  IKPD 02-05
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00154037
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13