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Investigation of Vascular Relaxing Effects of Candesartan and Pioglitazone.

Information source: Technische Universität Dresden
ClinicalTrials.gov processed this data on August 20, 2015
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: Technische Universität Dresden

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Vascular reactivity

Secondary outcome:

Pulse wave velocity

Changes 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
Last updated: September 12, 2006

Page last updated: August 20, 2015

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