ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Irbesartan in Hypertension

This study has been completed.

Sponsors and Collaborators: Sanofi-Aventis
Bristol-Myers Squibb
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00265967
  Purpose

Study objectives:

  • To demonstrate the effect of irbesartan on the regulation of diastolic blood pressure, in case of missing one dose after a period of administration for 6 to 8 weeks
  • To evaluate the safety of irbesartan

Condition Intervention Phase
Hypertension
Drug: Irbesartan
Phase IV

MedlinePlus related topics:   High Blood Pressure   

ChemIDplus related topics:   Irbesartan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Missed Dose Effect of Irbesartan in Hypertensive Patients and Cardiovascular Risk Profile Monitoring Under Irbesartan Treatment

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Changes in 24 hours mean ambulatory blood pressure on the missing dose day. Frequency, severity, seriousness of adverse events emerging during the treatment , and their relation with the study drug. [ Time Frame: at the end of 6th months to 8th ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diastolic blood pressure measurements recorded in patients' diaries, and during visits. [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]

Enrollment:   88
Study Start Date:   September 2005
Primary Completion Date:   February 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Irbesartan
Drug: Irbesartan
Irbesartan 150-300 mg/d for 8 weeks

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Having an average value of ≥ 95 mmHg and ≤ 109 mmHg in diastolic blood pressure measurement or an average diastolic blood pressure value of ≥ 85 mmHg in 24-hours arterial blood pressure measurement,
  • Received no treatment within the last 3 months.

Exclusion Criteria:

  • Premenopausal women having at least one of the following conditions,

    • Not surgically sterile,
    • Are nursing,
    • Having childbearing potential and not using a reasonable contraception method or not thinking to continue the method throughout the study. Reasonable contraception methods are: intrauterine device, oral or implantable or injectable contraception methods. No methods other than these are accepted.
  • Patients routinely sleeping within the day since she/he works at nightshift and whose working hours continue in a time shift from midnight to 04:00 A.M.
  • Patients with average systolic blood pressure = 180 mmHg in sitting position or average diastolic blood pressure is ≥110 mmHg in sitting position at baseline visit
  • Having known or suspected secondary hypertension
  • Having renal and/or hepatic failure together with the following laboratory criteria:

    • Having elevated values of SGPT (ALT) or SGOT (ALT) (at least twice the upper limit of normal range)
    • Having serum creatinine levels of > 2.3 mg/dL (or > 203 μmol/L)
  • With bilateral renal artery stenosis or single kidney and unilateral renal artery stenosis or those in post-renal transplantation or with single kidney,
  • Having symptomatic sodium insufficiency, hypokalemia or hyperkalemia,
  • With volume deficiency,
  • With primary hyperaldosteronism,
  • With biliary obstructive disorders,
  • Having congestive heart failure (New York Heart Association (NYHA)-functional class CHF III-IV),
  • With unstable angina pectoris occurring within 3 months before he or she signed the informed consent.
  • With stroke occurring within 6 months before he or she signed the informed consent,
  • With myocardial infarction or having cardiac surgery within three months before he or she signed the informed consent,
  • Underwent PTCA (percutaneous transluminal coronary revascularization) within three months before he or she signed the informed consent,
  • Having continuous tachycardia, atrial fibrillation, atrial flutter or other clinical arrythmias defined by the investigator
  • With hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically related aortic or mitral valve stenosis,
  • With insulin-dependant diabetes mellitus whose blood sugar regulation could not be controlled within the last 3 months after a HbA1C measurement in which it is equal to 10%.
  • With a history of drug or alcohol addiction within the last 6 months before she or he signed the informed consent,
  • Receiving a drug other than those defined in protocol for blood pressure regulation,
  • Who have been participated in any investigational study within the prior month before she or he signed the informed consent
  • With a known hypersensitivity against any drug which will be used.

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: NCT00265967

Locations
Turkey
Sanofi-Aventis    
      Istanbul, Turkey

Sponsors and Collaborators
Sanofi-Aventis
Bristol-Myers Squibb

Investigators
Study Director:     Edibe Taylan     Sanofi-Aventis    
  More Information


CSR synopsis  This link exits the ClinicalTrials.gov site
 

Responsible Party:   sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:   L_9917
First Received:   December 14, 2005
Last Updated:   September 28, 2008
ClinicalTrials.gov Identifier:   NCT00265967
Health Authority:   Turkey: Ministry of Health

Study placed in the following topic categories:
Irbesartan
Vascular Diseases
Angiotensin II
Hypertension

Additional relevant MeSH terms:
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers