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Completed

NCT Number: NCT00154037

Investigation of Vascular Relaxing 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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Clinical Pharmacology, Medical Faculty, University of Technology

Dresden, 01307, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pioglitazone (drug) and/or candesartan (drug)

Drug

Primary outcomes

  1. Vascular reactivity

Secondary outcomes

  1. Pulse wave velocity

  2. Changes in Angiotensin metabolites

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

Characterization of Vascular Effects of Candesartan and Pioglitazone.

Important dates

Study start
2005
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Sep 13, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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