Irbesartan in Hypertension

NCT00265967 | Completed Phase 4

• 1 other identifier: L_9917
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Outcome Measures

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.

  at the end of 6th months to 8th

Secondary Outcomes (1)

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

  6-8 weeks

Study Arms (1)

1

EXPERIMENTAL

Irbesartan

Drug: Irbesartan

Interventions

Irbesartan DRUG

Irbesartan 150-300 mg/d for 8 weeks

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Sanofi: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Sanofi-Aventis

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Edibe Taylan

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 14, 2005
• First Posted: December 15, 2005
• Study Start: September 1, 2005
• Primary Completion: February 1, 2007
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

TU (1)