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Irbesartan, Ciprofibrate and Their Combination Onto the Endothelial Functions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00350038
First Posted: July 10, 2006
Last Update Posted: January 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350038


Locations
Hungary
Sanofi-aventis
Budapest, Hungary
Sponsors and Collaborators
Sanofi
Bristol-Myers Squibb
Investigators
Study Director: László Erős, MD Sanofi-aventis, Hungary
  More Information

ClinicalTrials.gov Identifier: NCT00350038     History of Changes
Other Study ID Numbers: L_8759
First Submitted: July 7, 2006
First Posted: July 10, 2006
Last Update Posted: January 23, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Irbesartan
Ciprofibrate
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents