Text Size

Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol (IREDIS)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00549133
First received: October 24, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

To show that Irbesartan improves endothelial dysfunction and the procoagulant state which are thought to be the possible mechanisms, inducing a generalized vasculopathy associated with microalbuminuria and vascular events in type II diabetic hypertensive patients


Condition Intervention Phase
Hypertension
Diabetes Mellitus Type 2
 Drug: Irbesartan
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Evaluation of the effect of irbesartan on nitric oxide (NO), which has key role in the endothelial dysfunction and the development of pressure vasomotor response, compared to standard therapy (atenolol)

Secondary Outcome Measures:
  • Evaluation of the effect of irbesartan on chronic inflammatory process and tendency for procoagulation, associated with endothelial dysfunction, compared to atenolol.

Enrollment: 44
Study Start Date: October 2003
Study Completion Date: April 2005
  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • non insulin dependent type II manifest diabetes with glycosilated HbA1c levels over %6.5-8
  • mild to moderate hypertension stage I and stage II according to ESC-ESH 2003 (140-180 mmHg)

Exclusion Criteria:

  • congestive heart failure
  • azotemia
  • insulin dependent diabetes
  • liver insufficiency
  • pregnancy
  • cancer

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: NCT00549133

Locations
Turkey
Sanofi-Aventis
Istanbul, Turkey
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Edibe Taylan Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00549133     History of Changes
Other Study ID Numbers: L_9130
Study First Received: October 24, 2007
Last Updated: October 24, 2007
Health Authority: Turkey: Ministry of Health

Keywords provided by Sanofi:
Microalbuminaria in hypertensive patients with type II diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Atenolol
Irbesartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 23, 2013