Investigation of Vascular Relaxing Effects of Candesartan and Pioglitazone.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Subjects

Keywords

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vascular reactivity venodilation pulse wave velocity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pioglitazone (drug) and/or candesartan (drug)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Wilhelm Kirch, MD

Role: STUDY_CHAIR

Institute of Clinical Pharmacology

Locations

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Institute of Clinical Pharmacology, Medical Faculty, University of Technology

Dresden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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IKPD 02-05

Identifier Type: -

Identifier Source: org_study_id