Investigation of Vascular Relaxing Effects of Candesartan and Pioglitazone.
September 12, 2006 updated by: Technische Universität Dresden
Characterization of Vascular Effects of Candesartan and Pioglitazone.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dresden, Germany, 01307
- Institute of Clinical Pharmacology, Medical Faculty, University of Technology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Vascular reactivity
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Secondary Outcome Measures
Outcome Measure |
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Pulse wave velocity
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Changes in Angiotensin metabolites
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Study Completion
September 1, 2006
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
September 13, 2006
Last Update Submitted That Met QC Criteria
September 12, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IKPD 02-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.