Skip to main content
OpenTrials
Completed

NCT Number: NCT00265967

Irbesartan in Hypertension

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irbesartan

Drug

Irbesartan 150-300 mg/d for 8 weeks

Primary outcomes

  1. 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

Secondary outcomes

  1. Diastolic blood pressure measurements recorded in patients' diaries, and during visits.

    Time frame: 6-8 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
First posted
Dec 15, 2005
Registry last updated
Dec 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.