Irbesartan, Ciprofibrate and Their Combination Onto the Endothelial Functions

This study has been completed.
Bristol-Myers Squibb
Information provided by:
Sanofi Identifier:
First received: July 7, 2006
Last updated: January 18, 2008
Last verified: January 2008
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
Drug: Irbesartan
Drug: Ciprofibrate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00350038

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

No publications provided Identifier: NCT00350038     History of Changes
Other Study ID Numbers: L_8759
Study First Received: July 7, 2006
Last Updated: January 18, 2008
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 27, 2015