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...
Date First Received: July 7, 2006
Last Updated: January 18, 2008
Verified by: Sanofi-Aventis, January 2008
Clinical Trial Phase: Phase 4 | Start Date: February 2005
Overall Status: Completed
Estimated Enrollment: 60
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.”
Condition Keyword(s):
Intervention(s):
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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 Sponsor Information
Lead Sponsor: Sanofi-Aventis
Overall Clinical Trial Officials and Contacts
László Erős, MD Study Director Sanofi-aventis, Hungary
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
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
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
