Irbesartan, Ciprofibrate and Their Combination Onto the Endothelial Functions

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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...

Brief Summary

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.”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Drug: Irbesartan
  • Drug: Ciprofibrate

Outcome Measures for this Clinical Trial

Primary Measures

  • Microvascular reactivity

Secondary Measures

  • Reach of target blood pressure
  • Measurements of safety laboratory parameters

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

László Erős, MD Study Director Sanofi-aventis, Hungary  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00350038

Study ID Number: L_8759

ClinicalTrials.gov Identifier: NCT00350038

Health Authority: Hungary: National Institute of Pharmacy

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00350038