Investigation of Vascular Relaxing Effects of Candesartan and Pioglitazone.

• Sponsor: Technische Universität Dresden (Other)
• Overall Status: Completed
• CT.gov ID: NCT00154037
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 11
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: Pioglitazone (drug) and/or candesartan (drug)	N/A

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Characterization of Vascular Effects of Candesartan and Pioglitazone.
• Study Start Date: Oct 1, 2005
• Study Completion Date: Sep 1, 2006

Outcome Measures

Primary Outcome Measures

1. Vascular reactivity []

Secondary Outcome Measures

1. Pulse wave velocity []

2. Changes in Angiotensin metabolites []

Eligibility Criteria

Criteria

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

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

Locations

	Site	City	State	Country	Postal Code
1	Institute of Clinical Pharmacology, Medical Faculty, University of Technology	Dresden		Germany	01307

Sponsors and Collaborators

• Technische Universität Dresden

Investigators

• Study Chair: Wilhelm Kirch, MD, Institute of Clinical Pharmacology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00154037
• Other Study ID Numbers: IKPD 02-05
• First Posted: Sep 12, 2005
• Last Update Posted: Sep 13, 2006
• Last Verified: Sep 1, 2006

• Keywords provided by , ,: vascular reactivity; venodilation; pulse wave velocity
• Additional relevant MeSH terms: Pioglitazone; Candesartan

Study Results

No Results Posted as of Sep 13, 2006