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Irbesartan, Ciprofibrate and Their Combination Onto the Endothelial Functions

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ClinicalTrials.gov Identifier: NCT00350038
Recruitment Status : Completed
First Posted : July 10, 2006
Last Update Posted : January 23, 2008
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi

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.

Condition or disease Intervention/treatment Phase
Hypertension Dyslipidemia Drug: Irbesartan Drug: Ciprofibrate Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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.
Study Start Date : February 2005
Estimated Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan
U.S. FDA Resources




Primary Outcome Measures :
  1. Microvascular reactivity

Secondary Outcome Measures :
  1. Reach of target blood pressure
  2. Measurements of safety laboratory parameters


Information from the National Library of Medicine

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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.


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

ClinicalTrials.gov Identifier: NCT00350038     History of Changes
Other Study ID Numbers: L_8759
First Posted: July 10, 2006    Key Record Dates
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