Status:
COMPLETED
Irbesartan in Hypertension
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00265967
Start Date
September 1 2005
Last Update
December 7 2009
Active Locations (1)
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1
Sanofi-Aventis
Istanbul, Turkey (Türkiye)