Investigation of Vascular Relaxing Effects of Candesartan and Pioglitazone. - Full Text View

Sponsor:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00154037

Purpose

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.

Condition	Intervention
Healthy Subjects	Drug: Pioglitazone (drug) and/or candesartan (drug)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Characterization of Vascular Effects of Candesartan and Pioglitazone.

Resource links provided by NLM:

Drug Information available for: Pioglitazone Pioglitazone hydrochloride CV 11974 Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

Vascular reactivity

Secondary Outcome Measures:

Pulse wave velocity
Changes in Angiotensin metabolites

Estimated Enrollment:	40
Study Start Date:	October 2005
Estimated Study Completion Date:	September 2006

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

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154037

Locations

Germany
Institute of Clinical Pharmacology, Medical Faculty, University of Technology
Dresden, Germany, 01307

Sponsors and Collaborators

Dresden University of Technology

Investigators

Study Chair:

Wilhelm Kirch, MD

Institute of Clinical Pharmacology

More Information

No publications provided

Study ID Numbers:	IKPD 02-05
Study First Received:	September 8, 2005
Last Updated:	September 12, 2006
ClinicalTrials.gov Identifier:	NCT00154037 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

vascular reactivity
venodilation
pulse wave velocity

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Candesartan cilexetil
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pioglitazone
Therapeutic Uses

Physiological Effects of Drugs
Candesartan
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010