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Irbesartan in Hypertension

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Irbesartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Edibe Taylan, Study Director, Affiliation: Sanofi

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

Clinical Details

Official title: Missed Dose Effect of Irbesartan in Hypertensive Patients and Cardiovascular Risk Profile Monitoring Under Irbesartan Treatment

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: Diastolic blood pressure measurements recorded in patients' diaries, and during visits.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Sanofi-Aventis, Istanbul, Turkey
Additional Information

Starting date: September 2005
Last updated: December 4, 2009

Page last updated: August 20, 2015

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