Irbesartan in Hypertension

Overview

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

Full Title of Study: “Missed Dose Effect of Irbesartan in Hypertensive Patients and Cardiovascular Risk Profile Monitoring Under Irbesartan Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2007

Interventions

  • Drug: Irbesartan
    • Irbesartan 150-300 mg/d for 8 weeks

Arms, Groups and Cohorts

  • Experimental: 1
    • Irbesartan

Clinical Trial Outcome Measures

Primary 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

Secondary Measures

  • Diastolic blood pressure measurements recorded in patients’ diaries, and during visits.
    • Time Frame: 6-8 weeks

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Collaborator
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Medical Affairs Study Director, sanofi-aventis
  • Overall Official(s)
    • Edibe Taylan, Study Director, Sanofi

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