Irbesartan, Ciprofibrate and Their Combination Onto the Endothelial Functions

This study has been completed.

Sponsors and Collaborators:	Sanofi-Aventis Bristol-Myers Squibb
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00350038

Purpose

The rationale of the study is to clarify whether the supplementation of irbesartan with ciprofibrate could increase the antihypertensive effect, could improve the endothelial functions, and/or could affect the atherogenic small-dense LDL-, oxydized LDL concentrations, onto the paraoxinase activity and on the CRP and insulin levels.

Condition	Intervention	Phase
Hypertension Dyslipidemia	Drug: Irbesartan Drug: Ciprofibrate	Phase IV

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Irbesartan Ciprofibrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Investigations of the Effects of Aprovel, Lipanor and Their Combination Onto the Endothelial Functions of Dyslipidemic Patients Measure by Laser Doppler Flow-Metry.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Microvascular reactivity

Secondary Outcome Measures:

Reach of target blood pressure
Measurements of safety laboratory parameters

Estimated Enrollment:	60
Study Start Date:	February 2005
Estimated Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	45 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

hypertensive + dyslipidemic + damaged endothelial function

Exclusion Criteria:

hepatic and kidney damage,
IDDM (Insulin Dependent Diabetes Mellitus)
Freckson V type hyperlipoproteinaemia

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350038

Locations

Hungary
Sanofi-aventis
Budapest, Hungary

Sponsors and Collaborators

Sanofi-Aventis

Bristol-Myers Squibb

Investigators

Study Director:

László Erős, MD

Sanofi-aventis, Hungary

More Information

Posting of Clinical Study Results This link exits the ClinicalTrials.gov site

Study ID Numbers:	L_8759
Study First Received:	July 7, 2006
Last Updated:	January 18, 2008
ClinicalTrials.gov Identifier:	NCT00350038
Health Authority:	Hungary: National Institute of Pharmacy

Study placed in the following topic categories:

Metabolic Diseases
Ciprofibrate
Irbesartan
Vascular Diseases
Angiotensin II

Metabolic disorder
Dyslipidemias
Lipid Metabolism Disorders
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009