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Irbesartan in Hypertension
This study has been completed.
Study NCT00265967   Information provided by Sanofi-Aventis
First Received: December 14, 2005   Last Updated: September 28, 2008   History of Changes

December 14, 2005
September 28, 2008
September 2005
February 2007   (final data collection date for primary outcome measure)
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 ]
Changes in 24 hour 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.
Complete list of historical versions of study NCT00265967 on ClinicalTrials.gov Archive Site
Diastolic blood pressure measurements recorded in patients' diaries, and during visits. [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
Diastolic blood pressure measurements recorded in patients’ diaries, and during visits.
 
Irbesartan in Hypertension
Missed Dose Effect of Irbesartan in Hypertensive Patients and Cardiovascular Risk Profile Monitoring Under Irbesartan Treatment

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
 
Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Hypertension
Drug: Irbesartan
Experimental: Irbesartan
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
88
 
February 2007   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00265967
Medical Affairs Study Director, sanofi-aventis
L_9917
Sanofi-Aventis
Bristol-Myers Squibb
Study Director: Edibe Taylan Sanofi-Aventis
Sanofi-Aventis
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP