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Irbesartan, Ciprofibrate and Their Combination Onto the Endothelial Functions

Primary Purpose

Hypertension, Dyslipidemia

Status

Completed

Phase

Phase 4

Locations

Hungary

Study Type

Interventional

Intervention

Irbesartan

Ciprofibrate

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-aventis

Outcomes

Primary Outcome Measures

Microvascular reactivity

Secondary Outcome Measures

Reach of target blood pressure

Measurements of safety laboratory parameters

Full Information

NCT ID

NCT00350038

First Posted

July 7, 2006

Last Updated

January 18, 2008

Sponsor

Sanofi

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00350038

Brief Title

Irbesartan, Ciprofibrate and Their Combination Onto the Endothelial Functions

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

Collaborators

Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Dyslipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Irbesartan

Intervention Type

Drug

Intervention Name(s)

Ciprofibrate

Primary Outcome Measure Information:

Title

Microvascular reactivity

Secondary Outcome Measure Information:

Title

Reach of target blood pressure

Title

Measurements of safety laboratory parameters

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

László Erős, MD

Organizational Affiliation

Sanofi-aventis, Hungary

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-aventis

City

Budapest

Country

Hungary

12. IPD Sharing Statement

Learn more about this trial

Irbesartan, Ciprofibrate and Their Combination Onto the Endothelial Functions

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