Irbesartan in Hypertension

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Irbesartan

• Registration Number: NCT00265967
• Lead Sponsor: Sanofi

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 the safety of irbesartan

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-12-14
• Study First Submitted QC: 2005-12-14
• Study First Posted: 2005-12-15
• Primary Completion: 2007-02
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Irbesartan	Irbesartan

Primary Outcome Measures

Name	Time	Method
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.	at the end of 6th months to 8th

Secondary Outcome Measures

Name	Time	Method
Diastolic blood pressure measurements recorded in patients' diaries, and during visits.	6-8 weeks

Trial Locations

Locations (1)

Sanofi-Aventis; 🇹🇷 Istanbul, Turkey