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Irbesartan, Ciprofibrate and Their Combination Onto the Endothelial Functions

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00350038
First received: July 7, 2006
Last updated: January 18, 2008
Last verified: January 2008
History of Changes
  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
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:

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

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

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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:
Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Ciprofibrate
Irbesartan
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 16, 2013