Irbesartan in Hypertension

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Bristol-Myers Squibb
• Treatments: Irbesartan

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.