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NCT00350038 Clinical Trial

Irbesartan, Ciprofibrate and Their Combination Onto the Endothelial Functions

Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00350038
Other study ID # L_8759
Secondary ID
Status Completed
Phase Phase 4
First received July 7, 2006
Last updated January 18, 2008
Start date February 2005
Est. completion date August 2007

Study information
Verified date January 2008
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Hungary: National Institute of Pharmacy
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 70 Years
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Irbesartan

• Ciprofibrate

Locations
Country Name City State
Hungary Sanofi-aventis Budapest

Sponsors (2)
Lead Sponsor Collaborator
Sanofi Bristol-Myers Squibb

Country where clinical trial is conducted

Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Primary Microvascular reactivity
Secondary Reach of target blood pressure
Secondary Measurements of safety laboratory parameters
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