Irbesartan in Hypertension

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00265967
First received: December 14, 2005
Last updated: December 4, 2009
Last verified: December 2009
  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:


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 April 21, 2014