Official Title: “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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2007

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Irbesartan

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
    Safety Issue?: No

Secondary Measures

• Diastolic blood pressure measurements recorded in patients' diaries, and during visits.
  • Time Frame: 6-8 weeks
    Safety Issue?: No

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Edibe Taylan Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00265967

Study ID Number: L_9917

ClinicalTrials.gov Identifier: NCT00265967

Health Authority: Turkey: Ministry of Health

CSR synopsis