Investigation of Vascular Relaxing Effects of Candesartan and Pioglitazone.
Information source: Dresden University of Technology
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Subjects
Intervention: Pioglitazone (drug) and/or candesartan (drug) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Dresden University of Technology Official(s) and/or principal investigator(s):
Wilhelm Kirch, MD, Study Chair, Affiliation: Institute of Clinical Pharmacology
Summary
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.
Clinical Details
Official title: Characterization of Vascular Effects of Candesartan and Pioglitazone.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Vascular reactivity
Secondary outcome: Pulse wave velocityChanges in Angiotensin metabolites
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Male.
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
Locations and Contacts
Institute of Clinical Pharmacology, Medical Faculty, University of Technology, Dresden 01307, Germany
Additional Information
Starting date: October 2005
Ending date: September 2006
Last updated: September 12, 2006
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