Irbesartan in Hypertension - Full Text View

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: Irbesartan	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Missed Dose Effect of Irbesartan in Hypertensive Patients and Cardiovascular Risk Profile Monitoring Under Irbesartan Treatment

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Irbesartan

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Diastolic blood pressure measurements recorded in patients' diaries, and during visits. [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]

Enrollment:	88
Study Start Date:	September 2005
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Irbesartan	Drug: Irbesartan Irbesartan 150-300 mg/d for 8 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265967

Locations

Turkey
Sanofi-Aventis
Istanbul, Turkey

Sponsors and Collaborators

Sanofi

Bristol-Myers Squibb

Investigators

Study Director:

Edibe Taylan

Sanofi

More Information

No publications provided

Responsible Party:	Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00265967 History of Changes
Other Study ID Numbers:	L_9917
Study First Received:	December 14, 2005
Last Updated:	December 4, 2009
Health Authority:	Turkey: Ministry of Health

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Irbesartan
Antihypertensive Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013