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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
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

Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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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 Identifier: NCT00350038     History of Changes
Other Study ID Numbers: L_8759
Study First Received: July 7, 2006
Last Updated: January 18, 2008

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Hypolipidemic Agents
Lipid Regulating Agents processed this record on September 21, 2017